# US 9,867,718 B2 · Intervertebral implants, systems, and methods of use

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- Number: US 9,867,718 B2
- Document ID: US9867718B2
- Status: Granted
- Kind: B2
- Application number: 14/520,690
- Filed: 2014-10-22
- Published: 2016-04-28
- Granted: 2018-01-16
- Earliest claimed: 2014-10-22
- Assignees: DePuy Synthes Products, Inc.
- Applicants: DePuy Synthes Products, Inc.
- Inventors: Kurt Schmura; Edwin Chan; Benjamin Chronister; Raymond Murphy; Michael Jacene
- Web page: https://patentgrep.com/patent/US9867718B2

## CPC

- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- 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 2/4637: {for connecting or disconnecting two parts of a prosthesis}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61F 2002/30057: {made from both cortical and cancellous adjacent parts}
- A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped}
- A61F 2002/30387: {Dovetail connection}
- A61F 2002/30433: {using additional screws, bolts, dowels, rivets or washers e.g. connecting screws}
- A61F 2002/30774: {internally-threaded}
- A61F 2002/30787: {inclined obliquely with respect to each other}
- A61F 2002/30904: {serrated profile, i.e. saw-toothed}
- A61F 2002/4628: {with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping}
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00359: Bone or bony tissue
- 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

An intervertebral implant frame that is configured to engage a spacer can include a pair of arms that extend longitudinally from a support member such that the arms engage the spacer. The spacer can be made from bone graft, and include a first spacer body made of cortical bone, and a second spacer body made of cancellous bone.

## Claims

### Claim 1

An intervertebral implant configured to be inserted into an intervertebral space, the intervertebral implant comprising:
a spacer including:
a cortical spacer body comprising a cortical bone graft material;
a cancellous spacer body comprising a cancellous bone graft material, the cancellous spacer body disposed proximal with respect to at least a portion of the cortical spacer body,
wherein the spacer defines a proximal end that comprises the cancellous spacer body and none of the cortical spacer body, and a distal end that is spaced from the proximal end in a distal direction, the distal end comprising the cortical spacer body and none of the cancellous spacer body; and
a frame including a support member disposed proximal with respect to the cancellous spacer body and configured to extend along a portion of the cancellous spacer body, such that the cancellous spacer body is disposed between the support member and the at least a portion of the cortical spacer body,
wherein the frame defines at least one fixation element receiving aperture that extends through the support member, such that a fixation element inserted through the fixation element receiving aperture toward the spacer travels from the support member and through the cancellous bone graft material without passing through any of the cortical bone graft material.

### Claim 2 (depends on 1)

The intervertebral implant as recited in claim 1, wherein the frame further includes first and second opposed arms that extend from the support member and are configured to engage the cortical spacer body.

### Claim 3 (depends on 2)

The intervertebral implant as recited in claim 2, wherein the frame includes at least one retention member that extends from the first arm along a direction toward the second arm, and at least one retention member that extends out from the second arm along a direction toward the first arm, and the cortical spacer body is configured to receive the retention members so as to attach the frame to the spacer.

### Claim 4 (depends on 3)

The intervertebral implant as recited in claim 3, wherein the cortical spacer body defines at least one groove sized to receive the at least one retention member.

### Claim 5 (depends on 3)

The intervertebral implant as recited in claim 3, wherein the at least one retention member is configured to bite into the cortical spacer body so as to create a recess that retains the at least one retention member.

### Claim 6 (depends on 1)

The intervertebral implant as recited in claim 1, wherein the spacer includes opposed side surfaces spaced from each other along a lateral direction that is perpendicular to the distal direction,
wherein the intervertebral implant is configured for insertion in the distal direction, wherein the distal direction is oriented along a lateral approach, an anterior-posterior approach, or an oblique approach into the intervertebral space.

### Claim 7 (depends on 6)

The intervertebral implant as recited in claim 6, wherein the distal end has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, the proximal end has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, and the width of the distal end is less than the width of the proximal end.

### Claim 8 (depends on 1)

The intervertebral implant as recited in claim 1, wherein the frame defines four fixation element receiving apertures that extend through the support member, such that four fixation elements that are inserted through respective ones of the four fixation element receiving apertures and pass entirely through the spacer travel through the cancellous bone graft material without passing through any of the cortical bone graft material.

### Claim 9 (depends on 8)

An intervertebral implant assembly comprising:
the intervertebral implant as recited in claim 8; and
the fixation elements as recited in claim 8.

### Claim 10 (depends on 1)

The intervertebral implant as recited in claim 1, wherein the at least one fixation element receiving aperture comprises a plurality of fixation element receiving apertures that extends through the support member, and all fixation elements that are inserted through respective ones of the fixation element receiving apertures pass entirely through the spacer travel through the cancellous bone graft material without passing through any of the cortical bone graft material.

### Claim 11

An intervertebral implant comprising:
a spacer including a cortical spacer body that comprises a cortical bone graft material, and a cancellous spacer body that comprises a cancellous bone graft material; and
a frame including a support member configured to extend along a portion of the cancellous spacer body, the frame further including first and second opposed arms that extend from the support member and are configured to engage the cortical spacer body;
wherein the frame defines at least one fixation element receiving aperture that extends through the support member, such that a fixation element inserted through the fixation element receiving aperture toward the spacer travels from the support member and through the cancellous bone graft material without passing through any of the cortical bone graft material, and
wherein the spacer defines a proximal end surface and a distal end surface opposite the proximal end surface in a distal direction, the proximal end surface comprising the cancellous spacer body and none of the cortical spacer body, and the distal end surface comprising the cortical spacer body and none of the cancellous spacer body.

### Claim 12 (depends on 11)

The intervertebral implant as recited in claim 11, wherein 1) the spacer defines a top surface that extends from the proximal end surface to the distal end surface, and a bottom surface opposite the top surface, the bottom surface extending from the proximal end surface to the distal end surface, 2) the at least one fixation element creates at least one channel in the cancellous spacer body after it extends through the at least one fixation element receiving aperture, and 3) the at least one channel defines a first opening in the proximal end surface and a second opening in the top surface.

### Claim 13 (depends on 12)

The intervertebral implant as recited in claim 12, wherein the spacer further defines a pair of opposed side surfaces that extend between the proximal end surface and the distal end surface, the opposed side surfaces spaced from each other along a lateral direction, the distal end surface has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, the proximal end surface has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, and the width of the distal end is less than the width of the proximal end.

### Claim 14 (depends on 12)

The intervertebral implant as recited in claim 12, wherein the first opening is completely encircled by the proximal end surface.

### Claim 15 (depends on 12)

The intervertebral implant as recited in claim 12, wherein the at least one channel is open at an intersection of the proximal end surface and the top surface.

### Claim 16 (depends on 12)

The intervertebral implant as recited in claim 12, wherein the at least one channel is open at an intersection of the proximal end surface and the bottom surface.

### Claim 17

An intervertebral implant assembly comprising:
a spacer including a cortical spacer body comprising a cortical bone graft material, and a cancellous spacer body comprising a cancellous bone graft material, wherein the cortical spacer body at least partially surrounds the cancellous spacer body, such that a proximal end of the spacer comprises the cancellous spacer body and none of the cortical spacer body, and a distal end of the spacer comprises the cortical spacer body and none of the cancellous spacer body, the distal end opposite the proximal end in a distal direction;
a frame including a support member and first and second opposed arms that extend from the support member and are configured to engage the cortical spacer body so as to retain the spacer in a void that is defined by the support member and the first and second opposed arms; and
an expansion instrument including a first base and a first expansion arm that extends from the first base and is configured to be attached to the first arm of the frame, and a second base and a second expansion arm that extends from the second base and is configured to be attached to the second arm of the frame,
wherein the first base and the first expansion arm are separate from the second base and the second expansion arm, and a portion of one of the first and second bases is translatable in a portion of the other of the first and second bases as the first and second bases translate with respect to each other in their respective entireties so as to cause movement of at least one of the first and second expansion arms relative to the other of the first and second expansion arms, which in turn causes the respective at least one of the first and second arms of the frame to flex away from the other of the first and second arms of the frame.

### Claim 18 (depends on 17)

The intervertebral implant assembly as recited in claim 17, wherein the first expansion arm defines a projection that is inserted into a receiving aperture of the first arm of the frame, so as to attach the first expansion arm to the first arm of the frame, and the second expansion arm defines a projection that is inserted into a receiving aperture of the second arm of the frame, so as to attach the second expansion arm to the second arm of the frame.

### Claim 19 (depends on 17)

The intervertebral implant assembly as recited in claim 17, wherein the first expansion arm is monolithic with the first base, and the second expansion arm is monolithic with the second base.

### Claim 20 (depends on 17)

The intervertebral implant assembly as recited in claim 17, wherein the first expansion arm is coupled to the first base, and the second expansion arm is coupled to the second base.

### Claim 21 (depends on 17)

The intervertebral implant assembly as recited in claim 17, wherein the cancellous spacer body is disposed proximal with respect to at least a portion of the cortical spacer body, and the support member is disposed proximal with respect to the cancellous spacer body and configured to extend along a portion of the cancellous spacer body, such that the cancellous spacer body is disposed between the support member and the at least a portion of the cortical spacer body.

### Claim 22 (depends on 21)

The intervertebral implant assembly as recited in claim 21, wherein the frame defines at least one fixation element receiving aperture that extends through the support member, such that a fixation element inserted through the fixation element receiving aperture toward the spacer travels from the support member and through the cancellous bone graft material without passing through any of the cortical bone graft material.

### Claim 23 (depends on 22)

The intervertebral implant assembly as recited in claim 22, wherein the spacer includes opposed sides spaced from each other along a lateral direction that is perpendicular to the distal direction,
wherein the intervertebral implant is configured for insertion in the distal direction, wherein the distal direction is oriented along a lateral approach, an anterior-posterior approach, or an oblique approach into the intervertebral space.

### Claim 24 (depends on 23)

The intervertebral implant assembly as recited in claim 23, wherein the cortical spacer body and the cancellous spacer body define an interface therebetween at each of the opposed sides between the proximal end and the distal end.

### Claim 25 (depends on 22)

The intervertebral implant assembly as recited in claim 22, wherein 1) the spacer defines a proximal end surface, a distal end surface, a top surface that extends from the proximal end surface to the distal end surface, and a bottom surface opposite the top surface, the bottom surface extending from the proximal end surface to the distal end surface, 2) the at least one fixation element creates at least one channel in the cancellous spacer body after it extends through the at least one fixation element receiving aperture, and 3) the at least one channel defines a first opening in the proximal end surface and a second opening in the top surface.

### Claim 26 (depends on 25)

The intervertebral implant assembly as recited in claim 25, wherein at least a portion of the proximal end surface is defined by the cancellous spacer body.

### Claim 27 (depends on 25)

The intervertebral implant assembly as recited in claim 25, wherein the spacer further defines a pair of opposed side surfaces that extend between the proximal end surface and the distal end surface, the opposed side surfaces spaced from each other along a lateral direction, the distal end surface has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, the proximal end surface has a width along the lateral direction from one of the side surfaces to the other of the side surfaces, and the width of the distal end is less than the width of the proximal end.

### Claim 28 (depends on 25)

The intervertebral implant assembly as recited in claim 25, wherein the first opening is completely encircled by the proximal end surface.

### Claim 29 (depends on 25)

The intervertebral implant assembly as recited in claim 25, wherein the at least one channel is open at an intersection of the proximal end surface and the top surface.

### Claim 30 (depends on 25)

The intervertebral implant assembly as recited in claim 25, wherein the at least one channel is open at an intersection of the proximal end surface and the bottom surface.

### Claim 31 (depends on 17)

The intervertebral implant assembly as recited in claim 17, wherein the frame includes at least one retention member that extends from the first arm along a direction toward the second arm, and at least one retention member that extends out from the second arm along a direction toward the first arm, and the cortical spacer body is configured to receive the retention members so as to attach the frame to the spacer.

### Claim 32 (depends on 31)

The intervertebral implant assembly as recited in claim 31, wherein the cortical spacer body defines at least one groove sized to receive a respective one of the at least one retention members.

### Claim 33 (depends on 31)

The intervertebral implant assembly as recited in claim 31, wherein a respective one of the at least one retention members is configured to bite into the cortical spacer body so as to create a recess that retains the respective one of the at least one retention members.
