IMPLANTABLE VERTEBRAL FRAME SYSTEMS AND RELATED METHODS FOR SPINAL REPAIR

• US 20100152784A1
• Filed: 11/11/2009
• Published: 06/17/2010
• Est. Priority Date: 08/07/2007
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Transcorp, Inc
• Inventors: Veldman, Roger, Tuinstra, Scott, Lowry, David, O'Farrell, Desmond
• Granted Patent: US 8,709,054 B2
• Time in Patent Office: Days
• US Class Current: 606/282
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1728 for holes for bone plates or plate screws
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/8028 Cushions, i.e. elements forming interface between bone plate and bone
• CPC Class Codes: A61B 17/8042 the additional component being a cover over the screw head
• CPC Class Codes: A61B 17/808 Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30121 with lobes
• CPC Class Codes: A61F 2002/30123 with two diametrically opposed lobes
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws

Abstract

A system for performing surgical repair of the spine includes a distractor and a permanently implanted bone plate system. A surgical repair methodology is also disclosed that employs an implanted bone plate system with a substantially void internal volume which is attached to adjacent vertebrae subsequent to the distraction and adjustment of curvature of the vertebrae and prior to the excision of disc and/or end plate tissue through the bone plate. The device further facilitates the subsequent delivery of an interbody repair device for the purpose of either fusion or dynamic stabilization, such as by disc arthroplasty. The plate may be permanently implanted, such as when a fusion between the attached vertebral bodies is desired, but it need not be permanently implanted

Claims

1. A system for establishing and securing adjacent vertebrae in a defined spacial relationship, the system comprising:

at least one distraction device configured for temporary placement between adjacent vertebrae for achieving a desired spatial relationship between the vertebrae, the distraction device comprising a wedge portion and a head portion, the wedge portion having at least two non-parallel faces and configured to enter an intervertebral space between the adjacent vertebrae, the head portion having a height in a craniocaudal direction larger than a height of the wedge portion in the same direction to prevent the head portion from entering the intervertebral space;

at least one implantable vertebral frame configured to span between the adjacent vertebrae, the frame being configured to attach to each of the adjacent vertebra while the distraction device is in place to postoperatively maintain the desired spatial relationship between the vertebrae after the distraction device is removed, the frame having at least one internal operating aperture there-through for providing access to the intervertebral space, the aperture being configured to fit over the head portion of the distraction device, the aperture having a height in the craniocaudal direction nominally larger than the height of the head portion;

at least one interbody repair implant sized in relationship to the aperture of the frame to fit there-through and into the intervertebral space; and

at least one retention member attachable to the frame to cover at least a portion of the aperture.

2. The system of claim 1, wherein said frame is configured to span between and remain postoperatively attached to at least three adjacent vertebrae.

3. The system of claim 1, wherein said frame comprises external walls having integrally manufactured retractor blade engaging features.

4. The system of claim 1, wherein said frame has a plurality of through holes to facilitate attachment of said frame to adjacent vertebrae by means of bone screws.

5. The system of claim 1, wherein said frame has a plurality of protrusions thereon to facilitate attachment of said frame to the adjacent vertebrae by means of impingement into the bone tissue of the adjacent vertebrae.

6. The system of claim 1 wherein said retention member is configured to retain the interbody implant in its surgically established position.

7. The system of claim 1 wherein the frame is configured to receive bone screws there-through to attach the frame to the vertebrae, the retention member adapted to at least partially cover the bone screws when the member is attached to the frame to prevent back-out of the screws.

8. A method for applying the system in claim 1, wherein the adjacent vertebrae are distracted and spacially oriented with the distraction device, the vertebral frame is secured to the adjacent vertebrae, the damaged tissue is excised through the operating aperture in the vertebral frame, the vertebral interspace is prepared to receive the repair implant, said implant being placed through the operating aperture into said prepared interspace, and the retention member is then installed onto the vertebral frame.

9. A method for applying the system in claim 1, wherein the vertebral frame is attached to one or more vertebrae, the vertebrae are then distracted and spacially oriented by operating through the operating aperture in the vertebral frame, the vertebral frame is secured to each adjacent vertebrae, the damaged tissue is excised through the operating aperture in the vertebral frame, the vertebral interspace is prepared through the operating aperture to receive the repair implant, said interbody implant is inserted through the operating aperture into the prepared interspace and the retention member is installed onto the vertebral frame.

10. A method of fusing two or more adjacent vertebral bodies in a portion of a spinal column, the method comprising:

axially distracting adjacent vertebral bodies of the spinal column into a final prescribed spatial relationship using a distraction device placed between the vertebral bodies and engaging upon vertebral end plate tissue, the distraction device having a head portion that protrudes from between the adjacent vertebral bodies in an anterior direction;

centering a vertebral fixation frame relative to the distraction device in a craniocaudal direction by aligning a operating aperture through the frame with the head portion of the distracting device, the vertebral fixation frame configured to contact a surface of each of the vertebral bodies and comprising an implantable plate;

securing the vertebral fixation frame to the distracted adjacent vertebral bodies over the distraction device such that the vertebral bodies are maintained in their final prescribed spatial relationship after the fixation frame securing step is complete;

after the fixation frame securing step is complete, removing the distraction device from between the vertebral bodies through the operating aperture in the vertebral frame;

after the distraction device removing step, preparing a vertebral interspace to receive an interbody fusion implant by at least removing vertebral disc material through the aperture in the secured vertebral fixation frame, the adjacent vertebral bodies remaining in their final prescribed spatial relationship during the preparing step;

inserting the interbody fusion implant through the operating aperture and into the prepared interspace, and

maintaining the vertebral fixation frame in its originally secured position on the vertebral bodies postoperatively.

11. The method of claim 10, further comprising the step of excising bone material through the operating aperture in the vertebral frame.

12. The method of claim 11, wherein the step of excising bone material is performed entirely through the operating aperture of the vertebral frame.

13. The method of claim 10, further comprising the step of installing an interbody implant retention member onto the vertebral frame.

14. The method of claim 10, wherein the vertebral frame is secured to more than two adjacent vertebral bodies.

15. The method of claim 10, wherein the vertebral frame is maintained in an installed position permanently, generally from the time it is first secured to the vertebral bodies.

16. A system for establishing and securing adjacent vertebrae in a defined spacial relationship, the system comprising:

at least one implantable vertebral frame configured to span between the adjacent vertebrae, the frame being configured to attach to each of the adjacent vertebra to postoperatively maintain a desired spatial relationship between the vertebrae, the frame having at least one internal operating aperture there-through for providing access to the intervertebral space;

at least one interbody repair implant sized in relationship to the aperture of the frame to fit there-through and into the intervertebral space; and

at least one retention member attachable to the frame to cover at least a portion of the aperture, the retention member having a locking portion movable between an unlocked position and a locked position, the locking portion preventing the retention member from being separated from the frame when in the locked position.

17. The system of claim 16 wherein the locking portion comprises at least one section that contacts a posterior side of the frame when the locking portion is in the locked position.

18. The system of claim 16 wherein the locking portion comprises two sections that contact the posterior side of the frame on opposite sides of the operating aperture when the locking portion is in the locked position.

19. The system of claim 16 wherein the retention member further comprises at least one screw cover portion, wherein the screw cover portion covers at least part of a screw securing the frame to one of the adjacent vertebrae, the screw cover portion preventing the screw from backing out of the vertebra.

20. The system of claim 19 wherein the retention member further comprises two screw cover portions.

21. The system of claim 19 wherein the retention member further comprises four screw cover portions.

22. The system of claim 16 wherein the retention member further comprises a transitory locking portion having at least one resilient arm engageable with the frame for maintaining the retention member on the frame before the locking portion is moved from the unlocked position to the locked position.