Intervertebral implants, systems, and methods of use

• US 9,220,604 B2
• Filed: 12/21/2011
• Issued: 12/29/2015
• Est. Priority Date: 12/21/2010
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: McDonough, William P., Strausbaugh, William L., Chronister, Benjamin, Pepe, Thomas, Coover, Michael, Coffman, Katharine, Kueenzi, Thomas, Chan, Edwin, Pakzaban, Peyman, Schmura, Kurt
• Primary Examiner(s): Hoffman, Mary
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US13/333,065
• Publication Number:
  US 20120179259A1
• Time in Patent Office: 1,469 Days
• Field of Search: 606246-249, 623/17.11, 623/17.16
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: 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
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30477 using sharp protrusions, e.g. spikes, for anchoring into connecting prosthetic part
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/4622 having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00131 Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00299 : based on metal nitrides
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue

Abstract

An intervertebral implant frame that is configured to be attached to a spacer body can include a pair of arms that extend longitudinally from a support member such that the arms extend substantially around the spacer body. The arms may be configured to expand, crimp, or otherwise engage the spacer body to thereby hold the spacer body to the frame. The spacer body may be made from bone graft.

Claims

1. An intervertebral implant frame comprising:

a support member that defines an inner surface and an outer surface opposite the inner surface, and at least two fixation element receiving apertures that each extend along a respective central axis, each of the fixation element receiving apertures configured to receive a respective bone fixation element to thereby attach the intervertebral implant frame to first and second vertebral bodies, respectively when the intervertebral implant frame is disposed in an intervertebral space defined by first and second surfaces of the first and second vertebral bodies, respectively;

a first arm that extends from the support member and includes a first inner spacer contacting surface, the first arm defining a first terminal end; and

a second arm that extends from the support member and includes a second inner spacer contacting surface spaced from the first inner spacer contacting surface along a first direction, the second arm further including a first vertebral body contacting surface and a second vertebral body contacting surface spaced from the first vertebral contacting along a second direction, the second arm defining a second terminal end, each of the first and second outer terminal ends spaced from the support member along a third direction that is substantially perpendicular to the to both the first direction and the second direction so as to define a first length and a second length, respectively, the first and second lengths each sized to be greater than a third length measured from an anterior end of the first vertebral body to a centroid of the first vertebral body;

wherein

     1) the first and second inner spacer contacting surfaces define at least first and second respective contact locations, and at least one of the first and second arms is flexible so as to be movable between a first position, whereby the frame defines a first distance between the first and second contact locations along the first direction, and a second position, whereby the frame defines a second distance between the first and second contact locations along the first direction, the second distance greater than the first distance, such that when in the second position, the at least one of the first and second arms is biased toward the first position, and

     2) the central axis of at least one of the at least two fixation element receiving apertures exits the outer surface of the support member at a location between the first and second vertebral body contacting surfaces with respect to the second direction.

2. The intervertebral implant frame of claim 1, wherein the first and second lengths are each between about 3.5 mm and about 12 mm.

3. The intervertebral implant frame of claim 2, wherein the first and second lengths are each between about 6.0 mm and about 10 mm.

4. The intervertebral implant frame of claim 1, wherein the first and second lengths each define a value, respectively, such that the support member, the first arm, and the second arm collectively extend around at least 51% but no more than 99% of a perimeter of a spacer body when the spacer body is retained by the intervertebral implant frame.

5. The intervertebral implant frame of claim 4, wherein the first and second lengths each define a value, respectively, such that the support member, the first arm, and the second arm collectively extend around at least 80% but no more than 99% of the perimeter of the spacer body when the spacer body is retained by the intervertebral implant frame.

6. The intervertebral implant frame of claim 1, wherein the first and second arms are capable of retaining a spacer body consisting of cancellous bone.

7. The intervertebral implant frame of claim 1, wherein the first and second arms each include at least one retention member that extends out of the respective spacer contacting surface, and is configured to engage a spacer body.

8. The intervertebral implant frame of claim 1, wherein the first arm and the second arm are angled toward each other such that the inner surface of the support member and the first inner spacer contacting surface form an angle that is less than 90°

, and the inner surface of the support member and the second inner spacer contacting surface form an angle that is less than 90°

.

9. The intervertebral implant frame of claim 1, wherein the first and second lengths are between about 50% and 100% of an anterior-posterior length of the intervertebral space.

10. The intervertebral implant frame of claim 1, wherein the first and second arms each include a substantially straight portion that extends from the support member, and a distal bent portion that extends inward from a distal end of the substantially straight portion at an angle such that the bent portions are configured to contact a distal surface of a spacer body when the intervertebral implant frame is retaining the spacer body to thereby prevent the spacer body from separating from the intervertebral implant frame.

11. The intervertebral implant frame of claim 1, wherein the first and second arms each define a respective distal portion and a respective proximal portion, the distal portions each define a superior vertebral body contacting surface and an inferior vertebral body contacting surface, the proximal portions each define a superior vertebral body contacting surface and an inferior vertebral body contacting surface.

12. The intervertebral implant frame of claim 11, wherein a line drawn between the superior vertebral body contacting surfaces of the first arm forms an angle between about 0°

and about −

5°

with respect to an insertion direction of the intervertebral implant frame, and a line drawn between the superior vertebral body contacting surfaces of the second arm forms an angle between about 0° and

about −

5°

with respect to the insertion direction of the intervertebral implant frame.

13. The intervertebral implant frame of claim 12, wherein a line drawn between the inferior vertebral body contacting surfaces of the first arm forms an angle between about 0°

and about 5°

with respect to the insertion direction of the intervertebral implant frame, and a line drawn between the inferior vertebral body contacting surfaces of the second arm forms an angle between about 0° and

about 5°

with respect to the insertion direction of the intervertebral implant frame.

14. The intervertebral implant frame of claim 1, wherein the first and second arms each include a superior cut-out and an inferior cut-out to thereby provide visual access to the superior vertebral body and to the inferior vertebral body respectively when the intervertebral implant frame is disposed in the intervertebral space.

15. The intervertebral implant frame of claim 14, wherein the first and second arms each include a window that extends through the first and second arms to thereby provide visual access to a spacer body through the first and second arms when the intervertebral implant frame is retaining the spacer body.

16. The intervertebral implant frame of claim 1, wherein the first and second arms each include an expansion instrument engagement member.

17. The intervertebral implant frame of claim 16, wherein the expansion instrument engagement members each define a dove-tailed slot.

18. The intervertebral implant frame of claim 17, wherein the dove-tailed slots are each open at their distal ends, such that an expansion instrument can engage the dove-tailed slots in a direction that is opposite to an insertion direction of the intervertebral implant frame.

19. The intervertebral implant frame of claim 16, wherein the expansion instrument engagement members each define a slot that extends through the first and second arms.

20. The intervertebral implant frame of claim 1, wherein at least one of the first and second arms is flexible so as to be movable between the second position to a third position whereby the frame defines a third distance between the first and second contact locations along the first direction, the third distance less than the second distance.

21. An intervertebral implant frame comprising:

a support member that defines an inner surface and at least two fixation element receiving apertures that are each configured to receive a respective bone fixation element to thereby attach the frame to first and second vertebral bodies when the intervertebral implant frame is disposed in an intervertebral space defined by the first and second vertebral bodies;

a first flexible arm that extends from the support member and defines a first inner spacer contacting surface, a first outer surface opposite the first inner spacer contacting surface, and a first engagement member defined by the first outer surface;

a second flexible arm that extends from the support member and defines a second inner spacer contacting surface that is spaced from the first inner spacer contacting surface, a second outer surface opposite the second inner spacer contacting surface, and a second engagement member defined by the second outer surface, wherein the inner surface of the support member and the first and second inner spacer contacting surfaces at least partially define a void configured to receive a spacer body that ingrows with the first and second vertebral bodies when the spacer is disposed in the intervertebral space;

wherein the first and second engagement members are configured to receive respective first and second expansion forces from an expansion instrument prior to insertion of the spacer body into the void, such that at least one of the first and second flexible arms elastically expands with respect to the other of the first and second arms in response to the expansion force.

22. The intervertebral implant frame of claim 21 wherein the first and second arms each have a length that is between about 3.5 mm and about 12 mm.

23. The intervertebral implant frame of claim 22, wherein the first and second arms each have a length that is between about 6.0 mm and about 10 mm.

24. The intervertebral implant frame of claim 21, wherein the first and second arms each have a length such that the support member, the first arm, and the second arm extend around at least 51% but no more than 99% of the spacer body when the spacer body is retained by the intervertebral implant frame.

25. The intervertebral implant frame of claim 21, wherein the first and second arms are capable of retaining a spacer body consisting of cancellous bone, cortical bone, or both cancellous and cortical bone.

26. The intervertebral implant frame of claim 21, wherein the first and second arms each include at least one retention member that extends out of the first and second spacer contacting surfaces, respectively, and is configured to engage the spacer body.

27. The intervertebral implant frame of claim 26, wherein the first arm and the second arm are angled toward each other such that the inner surface of the support member and the first inner spacer contacting surface forms an angle that is less than 90°

, and the inner surface of the support member and the second inner spacer contacting surface forms an angle that is less than 90°

.

28. The intervertebral implant frame of claim 21, wherein the first vertebral body is a superior vertebral body, the second vertebral body is an inferior vertebral body, the first and second arms each define a respective distal portion and a respective proximal portion, the distal portions each define a superior vertebral body contacting surface and an inferior vertebral body contacting surface, the proximal portions each define a superior vertebral body contacting surface and an inferior vertebral body contacting surface.

29. The intervertebral implant frame of claim 28, wherein a line drawn between the superior vertebral body contacting surfaces of the first arm forms an angle between about 0°

and about −

5°

with respect to an insertion direction of the intervertebral implant frame, the insertion direction substantially perpendicular to the first direction, and a line drawn between the superior vertebral body contacting surfaces of the second arm forms an angle between about 0° and

about −

5°

with respect to the insertion direction of the intervertebral implant frame.

30. The intervertebral implant frame of claim 29, wherein a line drawn between the inferior vertebral body contacting surfaces of the first arm forms an angle between about 0°

and about 5°

with respect to the insertion direction of the intervertebral implant frame, and a line drawn between the inferior vertebral body contacting surfaces of the second arm forms an angle between about 0° and

about 5°

with respect to the insertion direction of the intervertebral implant frame.

31. The intervertebral implant frame of claim 21, wherein the first vertebral body is a superior vertebral body, the second vertebral body is an inferior vertebral body, the first and second arms each include a superior cut-out and an inferior cut-out to thereby provide visual access to the superior vertebral body and inferior vertebral body when the intervertebral implant frame is disposed in the intervertebral space.

32. The intervertebral implant frame of claim 31, wherein the first and second arms each include a window that extends through the first and second arms to thereby provide visual access to the spacer body through the first and second arms when the intervertebral implant frame is retaining the spacer body.

33. The intervertebral implant frame of claim 21, wherein the engagement members each define a dove-tailed slot.

34. The intervertebral implant frame of claim 33, wherein the dove-tailed slots are each open at their distal ends, such that the expansion instrument engages the dove-tailed slots in a direction that is:

1) opposite to an insertion direction of the intervertebral implant frame, and

     2) substantially perpendicular to the first direction.

35. The intervertebral implant frame of claim 21, wherein the engagement members each define a slot that extends through the first and second arms.

36. The intervertebral implant frame of claim 21, wherein the first and second arms are configured to retain a first spacer body having a first maximum width and a second spacer body having a second maximum width that is different than the first maximum width.

37. The intervertebral implant frame of claim 21, wherein a first of the at least two fixation element receiving apertures is spaced from a second of the at least two fixation element receiving apertures by a first distance measured in a first direction, and the first and second engagement members are spaced from one another by a second distance measured in the first direction such that the second distance is greater than the first distance.

38. An intervertebral implant frame comprising:

a support member that defines an inner surface and at least two fixation element receiving apertures that are each configured to receive a respective bone fixation element to thereby affix the frame to superior and inferior vertebral bodies when the intervertebral implant frame is disposed in an intervertebral space that is defined by the superior and inferior vertebral bodies;

a first arm that extends from the support member and includes a first inner spacer contacting surface, and a first crimpable arm; and

a second arm that extends from the support member and includes a second inner spacer contacting surface spaced from the first inner spacer contacting surface along a first direction, and a second crimpable arm,

wherein the inner surface of the support member, and the first and second inner spacer contacting surfaces together define a void that is configured to receive a spacer body, and the first crimpable arm is configured to be bent toward the second arm, the second crimpable arm is configured to be bent toward the first arm to thereby engage the spacer body and retain the spacer body within the void, the intervertebral implant frame has a first position in which the spacer body can be disposed between the first arm and the second arm, and the intervertebral has a second position in which the first crimpable arm and the second crimpable arm are crimped toward each other to thereby apply a retention force to the spacer body.

39. The intervertebral implant frame of claim 38, wherein (i) the first arm includes a first hinge and the second arm includes a second hinge, and (ii) the first crimpable arm is configured to rotate about the first hinge and the second crimpable arm is configured to rotate about the second hinge.

40. The intervertebral implant frame of claim 38, wherein the first arm includes a third crimpable arm, and the second arm includes a fourth crimpable arm.

41. The intervertebral implant frame of claim 40, wherein (i) the first arm includes a third hinge and the second arm includes a fourth hinge, and (ii) the crimpable arm is configured to rotate about the third hinge and the fourth crimpable arm is configured to rotate about the fourth hinge.

42. The intervertebral implant frame of claim 38, wherein the first and second crimpable arms define crimping tabs that are configured to engage respective side surfaces of the spacer body.

43. The intervertebral implant frame of claim 42, wherein (i) the first arm includes a first hinge and the second arm includes a second hinge, and (ii) the first crimp tab is configured to rotate about the first hinge and the second crimp tab is configured to rotate about the second hinge.

44. The intervertebral implant frame of claim 43, wherein:

the first crimp tab includes a first inner spacer contacting surface configured to contact the spacer body when the spacer body is retained within the void, a first outer surface opposite the first inner spacer contacting surface, and a first engagement member defined by the first outer surface configured to receive a first expansion force from an expansion instrument prior to insertion of the spacer body into the void;

the second crimp tab includes a second inner spacer contacting surface configured to contact the spacer body when the spacer body is retained within the void, a second outer surface opposite the second inner spacer contacting surface, and a second engagement member defined by the second outer surface configured to receive a second expansion force from an expansion instrument prior to insertion of the spacer body into the void.

45. The intervertebral implant frame of claim 38, wherein the crimping tabs are disposed along an upper and lower edge of the first and second arms.

46. An intervertebral implant frame comprising:

a support member that defines an inner surface and at least two fixation element receiving apertures that are each configured to receive a respective bone fixation element to thereby attach the frame to first and second vertebral bodies when the intervertebral implant frame is disposed in an intervertebral space defined by the first and second vertebral bodies;

a first flexible arm that extends from the support member and defines a first inner spacer contacting surface;

a second flexible arm that extends from the support member and defines a second inner spacer contacting surface that is spaced from the first inner spacer contacting surface, wherein the inner surface of the support member and the first and second inner spacer contacting surfaces at least partially define a void configured to receive a spacer body that ingrows with the first and second vertebral bodies when the spacer is disposed in the intervertebral space;

wherein the first and second flexible arms include respective first and second engagement members define respective first and second dove-tailed slots that are configured to receive respective first and second expansion forces from an expansion instrument prior to insertion of the spacer body into the void, such that at least one of the first and second flexible arms elastically expands with respect to the other of the first and second arms in response to the expansion force.

47. The intervertebral implant frame of claim 46, wherein the first and second dove-tailed slots are each open at respective distal ends, such that the expansion instrument engages the dove-tailed slots in a direction that is opposite to an insertion direction of the intervertebral implant frame.