# US 11,896,497 B2 · Intervertebral spacer

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- Number: US 11,896,497 B2
- Document ID: US11896497B2
- Status: Granted
- Kind: B2
- Application number: 17/340,406
- Filed: 2021-06-07
- Published: 2021-09-23
- Granted: 2024-02-13
- Earliest claimed: 2008-10-13
- Assignees: Globus Medical, Inc.
- Applicants: Globus Medical, Inc.
- Inventors: Noah Hansell; Marcin Niemiec; William S. Rhoda; Michael Meccariello
- Web page: https://patentgrep.com/patent/US11896497B2

## CPC

- A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61F 2/4611: {of spinal prostheses}
- A61F 2/30734: {Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped}
- A61F 2002/30364: {Rotation about the common longitudinal axis}
- A61F 2002/30365: {with additional means for limiting said rotation}
- A61F 2002/30538: {for adjusting angular orientation}
- A61F 2002/30593: {hollow}
- A61F 2002/30594: {slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots}
- A61F 2002/30616: {Sets comprising a plurality of prosthetic parts of different sizes or orientations}
- A61F 2002/30622: {Implant for fusing a joint or bone material}
- A61F 2002/30785: {parallel}
- A61F 2002/3082: {Grooves}
- A61F 2002/30843: {Pyramidally-shaped}
- A61F 2002/30904: {serrated profile, i.e. saw-toothed}
- 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 2002/4629: {connected to the endoprosthesis or implant via a threaded connection}
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2250/0006: for adjusting angular orientation
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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

Disclosed is an assembly and method for implant installation between adjacent vertebral bodies of a patient. The implant has a support body and a rotatable insert therein and the support body is curved for installation between adjacent vertebral bodies transforaminally. An installation instrument is also disclosed for removable attachment to implant and engagement with the rotatable insert to selectively permit rotation between the insert and the support body. The installation instrument extends along a longitudinal tool axis and when the installation instrument is in a first position the insert is rotationally fixed with respect to the support body and when the installation instrument is in a second position the support body may rotate with respect to the insert.

## Claims

### Claim 1

An assembly for implant installation between adjacent vertebral bodies of a patient, comprising:
an implant having a support body and a rotatable insert therein;
the support body having a proximal end portion and a distal end portion and the support body being configured and dimensioned for installation between adjacent vertebral bodies;
wherein the support body includes a superior surface and an inferior surface,
wherein the support body defines a longitudinal opening extending between the superior surface and the inferior surface, and positioned between the proximal end and the distal portion to accommodate the rotatable insert therein, and
wherein the insert is rotatable about a central longitudinal axis within the longitudinal opening to permit the support body to rotate about the insert and the central longitudinal axis; and
wherein the insert includes a threaded hole extending transverse to the longitudinal axis to interface with an installation instrument and a counter-torque slot adjacent the threaded hole and extending transversely to the threaded hole.

### Claim 2 (depends on 1)

The assembly of claim 1, further comprising the installation instrument removably attached to the proximal end portion of the support body and engageable with the rotatable insert to selectively permit rotation between the insert and the support body, the installation instrument extending along a longitudinal tool axis.

### Claim 3 (depends on 1)

The assembly of claim 1, further comprising an alignment indicator disposed on a superior surface of the insert and aligned with the threaded hole.

### Claim 4 (depends on 2)

The assembly of claim 2, wherein the installation instrument includes a central shaft having a threaded tip portion for threaded engagement with the threaded hole of the rotatable insert.

### Claim 5 (depends on 4)

The assembly of claim 4, wherein the installation instrument comprises an implant stabilizer configured and dimensioned to engage the support body, an insert stabilizer configured and dimensioned to engage the rotatable insert, and wherein the central shaft extends through the implant and insert stabilizers.

### Claim 6 (depends on 5)

The assembly of claim 5, wherein the implant stabilizer has a generally cylindrical body extending from a proximal end to a distal end, and wherein the distal end comprises a forked free end having a pair of tongs spaced apart and extending distally therefrom and the tongs are configured and dimensioned to engage the one or more grooves of the implant to stabilize the implant with respect to the tongs and prevent rotation of the support body with respect to the longitudinal tool axis.

### Claim 7 (depends on 6)

The assembly of claim 6, wherein each of the superior surface and the inferior surface comprises a plurality of protrusions.

### Claim 8 (depends on 1)

The assembly of claim 1, wherein the insert includes a circumferential rib and the support body includes a correspondingly shaped indentation, and the insert is captured within the longitudinal opening of the support body when the insert is inserted therein.

### Claim 9 (depends on 8)

The assembly of claim 8, wherein the proximal end portion has a rounded shape and includes one or more grooves on lateral sides of the implant to engage the installation instrument and wherein the grooves are in communication with the longitudinal opening to allow a part of the installation instrument to engage the rotatable insert.

### Claim 10 (depends on 1)

The assembly of claim 1, further comprising a second longitudinal opening surrounded at least in part by one or more protrusions.

### Claim 11 (depends on 1)

The assembly of claim 1, wherein the support body further includes a groove that extends adjacent the proximal end portion and extends along an interior curved wall of the support body.

### Claim 12 (depends on 1)

The assembly of claim 1, wherein the insert includes a circumferential rib that mates to a corresponding indentation shaped on the support body.

### Claim 13 (depends on 1)

The assembly of claim 1, wherein the installation instrument comprises an implant stabilizer and an insert stabilizer.

### Claim 14

A method for implant installation between adjacent vertebral bodies of a patient, comprising the steps of:
assembling an implant onto an insertion tool;
the implant having a support body and a rotatable insert therein;
the support body having a proximal end portion and a distal end portion and the support body being configured and dimensioned for installation between adjacent vertebral bodies;
wherein the support body includes a superior surface and an inferior surface,
wherein the support body defines a longitudinal opening extending therethrough from the superior surface to the inferior surface and positioned in between the proximal end and the distal portion to accommodate the rotatable insert therein,
wherein the insert is rotatable about a central longitudinal axis within the longitudinal opening to permit the support body to rotate about the insert and the central longitudinal axis;
wherein the insert includes a threaded hole extending transverse to the longitudinal axis to interface with an installation instrument and a counter-torque slot adjacent the threaded hole and extending transversely to the threaded hole;
inserting the installation instrument through the threaded hole such that at least one projection contacts the counter-torque slot;
using the inserted installation instrument, inserting the implant into a patient between adjacent vertebral bodies of a patient such that the implant rotates with respect to the longitudinal tool axis.

### Claim 15 (depends on 14)

The method of claim 14, wherein the step of inserting the implant includes:
moving the installation instrument to a first position wherein the insert is rotationally fixed with respect to the support body and the implant is rotationally fixed with respect to the longitudinal tool axis;
placing the implant into a patient to locate the implant between adjacent vertebral bodies of a patient;
advancing the implant between the adjacent vertebral bodies into an intervertebral space therebetween;
moving the installation instrument to a second position wherein the support body is rotatable with respect to the insert;
advancing the implant further into the intervertebral space such that the implant rotates with respect to the longitudinal tool axis.

### Claim 16 (depends on 15)

The method of claim 15, wherein the distal end of the implant is tapered and configured to separate the adjacent vertebral bodies when the installation instrument is in a first position and the implant is advanced into the intervertebral space.

### Claim 17 (depends on 15)

The method of claim 15, wherein a lock is provided on the installation instrument to prevent the instrument from disengaging from the implant during impaction.

### Claim 18 (depends on 15)

The method of claim 15, wherein the implant and insert remain implanted in the patient.

### Claim 19 (depends on 15)

The method of claim 15, wherein the superior surface and the inferior surface comprise protrusions.
