# US 8,454,694 B2 · Interbody device and plate for spinal stabilization and instruments for positioning same

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- Number: US 8,454,694 B2
- Document ID: US8454694B2
- Status: Granted
- Kind: B2
- Application number: 13/040,035
- Filed: 2011-03-03
- Published: 2012-09-06
- Granted: 2013-06-04
- Earliest claimed: 2011-03-03
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: William Armstrong; Thomas Carls; John A. Cowan; James Duncan; Richard A. Hynes; Anthony J. Melkent; Jean-Pierre Mobasser; D. Hal Silcox
- Inventors: William Armstrong; Thomas Carls; John A. Cowan; James Duncan; Richard A. Hynes; Anthony J. Melkent; Jean-Pierre Mobasser; D. Hal Silcox
- Web page: https://patentgrep.com/patent/US8454694B2

## CPC

- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61B 17/7059: {Cortical plates (A61B17/7007, A61B17/7058 take precedence)}
- A61B 17/808: {Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms}
- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- 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 2/4611: {of spinal prostheses}
- A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping}
- A61F 2/4603: {for insertion or extraction of endoprosthetic joints or of accessories thereof}
- A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30365: {with additional means for limiting said rotation}
- A61F 2002/30383: {made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove}
- A61F 2002/30517: {using a locking plate}
- A61F 2002/3054: {about a connection axis or implantation axis for selecting any one of a plurality of radial orientations between two modular parts, e.g. Morse taper connections, at discrete positions, angular positions or continuous positions}
- A61F 2002/30576: {with extending fixation tabs}
- A61F 2002/30578: {having apertures, e.g. for receiving fixation screws}
- A61F 2002/30593: {hollow}
- A61F 2002/30624: {Hinged joint, e.g. with transverse axle restricting the movement}
- A61F 2002/30777: {Oblong apertures}
- A61F 2002/30779: {arcuate}
- A61F 2002/3082: {Grooves}
- A61F 2002/30904: {serrated profile, i.e. saw-toothed}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2002/4622: {having the shape of a forceps or a clamp}
- 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 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00329: Glasses, e.g. bioglass
- A61F 2310/00353: Bone cement, e.g. polymethylmethacrylate or PMMA
- A61F 2310/00359: Bone or bony tissue
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61F 2310/00371: Collagen
- A61F 2310/00377: Fibrin
- 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

Systems, methods and devices for providing stabilization between first and second vertebrae are provided. More particularly, in one form a system includes an implant configured to be positioned in a disc space between the first and second vertebrae and a freestanding plate for engagement with extradiscal surfaces of the first and second vertebrae. The system also includes an insertion instrument with an engaging portion configured to releasably engage with the implant and the plate such that the implant and plate can be positioned together relative to the first and second vertebrae. In one aspect, an angular orientation of the implant relative to the plate is adjustable when the implant and the plate are engaged by the instrument. In this or another aspect, the implant and plate are held in a contiguous relationship when engaged by the instrument. However, different forms and applications are also envisioned.

## Claims

### Claim 1

A system for providing spinal stabilization, comprising:
an implant including a body extending from a leading end to an opposite trailing end, said body including a superior bone engaging surface and an opposite inferior bone engaging surface, said superior and inferior bone engaging surfaces engaging respective endplates of upper and lower vertebrae when said implant is positioned in a spinal disc space between the upper and lower vertebrae;
a plate for engagement with the upper and lower vertebrae, said plate including a body extending between an upper end and an opposite lower end, said plate body including a top surface and an opposite bottom surface facing the upper and lower vertebrae when said plate is engaged therewith, said plate including a plurality of holes and a retaining element rotatably disposed on an outer surface of said plate, said retaining element comprising a plurality of arms separated by gaps such that said retaining element is rotatable between a first position where said arms do not cover said plurality of holes and a second position where said arms cover said plurality of holes; and
an insertion instrument including an engaging portion configured to releasably engage with said implant and said plate, wherein an angular orientation of said implant relative to said plate is adjustable when said implant and said plate are engaged by said instrument.

### Claim 2 (depends on 1)

The system of claim 1, wherein rotation of said plate relative to said instrument is limited when said implant and said plate are engaged by said insertion instrument.

### Claim 3 (depends on 2)

The system of claim 2, wherein engagement of said implant and said plate with said instrument prevents displacement of said implant relative to said plate and upon disengagement of said implant and said plate from said instrument said implant is freely displaceable relative to said plate.

### Claim 4 (depends on 1)

The system of claim 1, wherein said implant includes a first pair of receptacles positioned on opposite sides of said implant between said superior and inferior bone engaging surfaces and said plate includes a second pair of receptacles positioned on opposite sides of said plate between said top and bottom surfaces.

### Claim 5 (depends on 4)

The system of claim 4, wherein said engaging portion of said instrument includes a pair of oppositely positioned tines, said tines each including a first projection configured to be positioned in a respective one of said first pair of receptacles and a second projection configured to be positioned in a respective one of said second pair of receptacles.

### Claim 6 (depends on 5)

The system of claim 5, wherein said plate includes first and second grooves formed in said opposite sides and extending between said top and bottom surfaces, and a respective one of said second pair of receptacles is positioned in each of said first and second grooves.

### Claim 7 (depends on 6)

The system of claim 6, wherein said implant includes a first notch extending from a first one of said first pair of receptacles and opening through said trailing end of said implant and a second notch extending from a second one of said first pair of receptacles and opening through said trailing end of said implant.

### Claim 8 (depends on 7)

The system of claim 7, wherein said tines are positioned in respective ones of said first notch and said first groove and said second notch and said second groove when said implant and said plate are engaged by said instrument.

### Claim 9 (depends on 5)

The system of claim 5, wherein said first projections of said tines include a generally cylindrical shaped configuration and said second projections of said tines include a generally racetrack shaped configuration.

### Claim 10 (depends on 5)

The system of claim 5, wherein said first projections of said tines are positioned at a distal end of said instrument and said second projections of said tines are spaced proximally of said first projections.

### Claim 11 (depends on 1)

The system of claim 1, wherein said plate body includes a pair of holes adjacent to said upper end that extend through said top and bottom surfaces and a second pair of holes adjacent to said lower end that extend through said top and bottom surfaces, and further comprising a first pair of bone engaging fasteners extending through said first pair of holes for engagement with the upper vertebra and a second pair of bone engaging fasteners extending through said second pair of holes for engagement with the lower vertebra.

### Claim 12 (depends on 1)

The system of claim 1, wherein said plurality of holes are configured to facilitate insertion of one or more bone engaging fasteners through said insertion instrument and said plate into engagement with said vertebrae.

### Claim 13 (depends on 1)

The system of claim 1, wherein said retaining element is positioned equidistant between said upper and lower ends of said plate body and equidistant between opposite sides of said plate body.

### Claim 14

A system for providing spinal stabilization, comprising:
an implant including a body extending from a leading end to an opposite trailing end, said body including a superior bone engaging surface and an opposite inferior bone engaging surface, said superior and inferior bone engaging surfaces engaging respective endplates of upper and lower vertebrae when said implant is positioned in a spinal disc space between the upper and lower vertebrae;
a plate for engagement with the upper and lower vertebrae, said plate including a body extending between an upper end and an opposite lower end, said plate body including a proximal surface, an opposite distal surface, and a distal facing intermediate portion configured to cooperate with said trailing end of said implant, said plate including a plurality of holes and a retaining element rotatably disposed on an outer surface of said plate, said retaining element comprising a plurality of arms separated by gaps such that said retaining element is rotatable between a first position where said arms do not cover said plurality of holes and a second position where said arms cover said plurality of holes; and
an insertion instrument including an engaging portion configured to releasably engage with said implant and said plate, wherein said implant and said plate are held in a contiguous relationship when engaged by said instrument and said implant is displaceable from said plate upon disengagement of said instrument.

### Claim 15 (depends on 14)

The system of claim 14, wherein said trailing end of said implant cooperates with said intermediate portion of said plate when said implant and said plate are held in said contiguous relationship.

### Claim 16 (depends on 15)

The system of claim 15, wherein said trailing end of said implant is convexly rounded between said superior and inferior bone engaging surfaces and said intermediate portion of said plate includes a concave portion configured to receive at least a portion of said trailing end of said implant when said implant and said plate are held in said contiguous relationship.

### Claim 17 (depends on 16)

The system of claim 16, wherein said concave portion of said intermediate portion is offset distally from portions of said distal surface at said upper and lower ends of said plate.

### Claim 18 (depends on 15)

The system of claim 15, wherein said intermediate portion of said plate includes a convex portion, and said trailing end of said implant is concave between said superior and inferior bone engaging surfaces and configured to receive at least a portion of said intermediate portion of said plate when said implant and said plate are held in said contiguous relationship.

### Claim 19 (depends on 14)

The system of claim 14, wherein an angular orientation of said implant relative to said plate is adjustable when said implant and said plate are held in said contiguous relationship by said instrument.

### Claim 20 (depends on 14)

The system of claim 14, wherein said insertion instrument includes a plurality of guide holes configured to facilitate insertion of one or more bone engaging fasteners through said insertion instrument and said plate into engagement with said vertebrae.

### Claim 21

A method for providing spinal stabilization between first and second vertebrae, comprising:
providing an implant including a body extending from a leading end to an opposite trailing end, said body including a superior bone engaging surface and an opposite inferior bone engaging surface;
providing a plate for engagement with the first and second vertebrae, said plate including a body extending between an upper end and an opposite lower end, said plate including a plurality of holes and a retaining element rotatably disposed on an outer surface of said plate, said retaining element comprising a plurality of arms separated by gaps such that said retaining element is rotatable between a first position where said arms do not cover said plurality of holes and a second position where said arms cover said plurality of holes;
engaging an insertion instrument with said implant and said plate, said engaging including retaining said implant and said plate in a contiguous, uncoupled arrangement; and
inserting said leading end of said implant in a spinal disc space between the first and second vertebrae with said insertion instrument and advancing said implant into the disc space until a bottom surface of said plate contacts extradiscal surfaces of the first and second vertebrae.

### Claim 22 (depends on 21)

The method of claim 21, which further includes rotating said implant relative to said plate when said insertion instrument is engaged with said implant and said plate and said implant and said plate are retained in said contiguous, uncoupled arrangement.

### Claim 23 (depends on 21)

The method of claim 21, which further includes:
engaging said upper end of said plate to the first vertebra with at least one fastener and said lower end of said plate to the second vertebra with at least one fastener; and
disengaging said insertion instrument from said plate and said implant, wherein said disengaging allows displacement of said implant away from said plate.
