Transcorporeal spinal decompression and repair systems and related methods

• US 9,763,801 B2
• Filed: 04/30/2013
• Issued: 09/19/2017
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Lowry, David, O'Farrell, Desmond, Tuinstra, Scott, Veldman, Roger
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US13/874,273
• Publication Number:
  US 20130245765A1
• Time in Patent Office: 1,603 Days
• Field of Search: 606 86 R
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• 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 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/809 with bone-penetrating elements, e.g. blades or prongs bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites

Abstract

A system and method are provided for making an access channel through a vertebral body to access a site of neural compression, decompressing it, and repairing the channel to restore vertebral integrity. System elements include an implantable vertebral plate, a guidance device for orienting bone cutting tools and controlling the path of a cutting tool, a bone cutting tool to make a channel in the vertebral body, a tool for opening or partially-resecting the posterior longitudinal ligament of the spine, a tool for retrieving a herniated disc, an implantable device with osteogenic material to fill the access channel, and a retention device that lockably-engages the bone plate to retain it in position after insertion. System elements may be included in a surgery to decompress an individual nerve root, the spinal cord, or the cauda equina when compressed, for example, by any of a herniated disc, an osteophyte, a thickened ligament arising from degenerative changes within the spine, a hematoma, or a tumor.

Claims

1. A surgical system to form and repair an access channel through a vertebral body, the channel having an anterior surface entry and a posterior surface opening, the system comprising:

a trajectory control tool comprising a fastening portion configured to detachably secure the tool to the anterior surface of the vertebral body, the tool further comprising a trajectory control sleeve configured to receive at least a portion of a bone cutting tool, the sleeve configured to guide the cutting tool to form the access channel with a prescribed trajectory from the anterior entry to the prescribed posterior opening, the fastening portion being laterally spaced apart from the sleeve by a predetermined distance on the anterior surface of the vertebral body; and

a repair implant comprising a plug portion and a fastening portion separated by the same predetermined distance as in the trajectory control tool, the plug configured to fill at least a portion of the access channel and the fastening portion configured to permanently retain the repair implant on the vertebral body,

wherein the fastening portion of the repair implant includes a bore with a countersunk portion for mating with the head of a bone screw,

wherein the plug portion of the repair implant comprises a porous cage with a porosity sufficient to permit through movement of blood and bone cells,

wherein the porous cage includes a closeable cap configured to increase pressure within the cage as the cap is closed.

2. The surgical system of claim 1 wherein the prescribed trajectory has a compound angle according to a cranio-caudal axis and a medial lateral axis with respect to a reference plane tangential to the access channel entry on the anterior surface of the vertebral body.

3. The surgical system of claim 1 wherein the trajectory control sleeve includes a contact surface for engaging a corresponding surface on the bone cutting tool, the surfaces configured so as to limit the penetration of the cutting tool into the vertebral body to a prescribed depth.

4. The surgical system of claim 1 wherein the porous cage is configured to allow bone material to be placed in the cage and be in intimate contact with an interior surface of the access channel.

5. The surgical system of claim 1 wherein the porous cage is integrally formed with a plate portion of the repair implant, the plate portion being configured to contact the anterior surface of the vertebral body.

6. The surgical system of claim 1 wherein the composition of the porous cage comprises any of a polymer, a metal, metallic alloy, or a ceramic.

7. The surgical system of claim 6 wherein the polymer of the composition may include polyetheretherketone (PEEK), PEEK-reinforced carbon fiber, or hydroxyapatite-reinforced PEEK.

8. The surgical system of claim 1 wherein the porous cage includes a closeable opening through which bone material may be passed.

9. The surgical system of claim 1 wherein the porous cage includes a minimally compressive internal element adapted to enhance compressive force applied to contents of the porous cage upon application of compressive force to the cage.

10. The surgical system of claim 1 wherein a posterior surface of the repair implant includes one or more penetrating elements configured to impinge into the vertebral bone tissue.

11. The surgical system of claim 1 wherein a posterior surface of the repair implant is of sufficiently porous composition to support in-growth of bone.

12. The surgical system of claim 1 wherein the bone-cutting tool is any of a drill, a ream, a core cutter or a trephine.

13. The surgical system of claim 1 wherein a cutting element of the bone-cutting tool has a cutting diameter between about 5 mm and about 7 mm.

14. The surgical system of claim 1 wherein the plug portion of the repair implant has an external geometry complementary to the internal geometry of the access channel.

15. The surgical system of claim 1 wherein the repair implant includes an osteogenic agent.

16. The surgical system of claim 1 wherein the fastening portion of the trajectory control tool comprises a sleeve configured to removably receive an elongated fastening element for securing the tool to the vertebral body.

17. The surgical system of claim 16 further comprising an elongated fastening element having a proximal end and a distal end, the distal end being configured to thread into the vertebral body, the fastening element having a length sufficient to extend the proximal end outside of a patient when the distal end is threaded into the vertebral body.

18. A method for performing a procedure through a vertebral body overlaying a site in need of a medical procedure comprising:

forming a screw hole in an anterior surface of the vertebral body;

temporarily attaching a trajectory control sleeve on the anterior surface by inserting a fastener into the screw hole;

inserting at least a portion of a bone cutting tool through the trajectory control sleeve;

forming an access channel with a prescribed trajectory from an entry point on the anterior surface to an opening on the posterior surface of the vertebral body in the locale of the site in need of the procedure by removing bone with the bone cutting tool;

removing the trajectory control sleeve from the vertebral body;

performing the medical procedure through the access channel and the opening on the posterior surface of the vertebral body;

installing a repair implant at least partially within the access channel, wherein the repair implant comprises a plug formed by a cylindrical sidewall, wherein the cylindrical sidewall includes a plurality of holes that extend from an outer surface of the sidewall to an inner surface of the sidewall;

fastening the repair implant to the vertebral body using the previously formed screw hole;

harvesting bone tissue from the vertebral body when forming the access channel and placing the harvested bone tissue within a porous cage of the repair implant; and

perfusing at least some bone tissue or bone-associated biological fluid from the repair implant into the vertebral body,

wherein the repair implant includes a bore with a countersunk portion for mating with a screw.

19. The method of claim 18 wherein performing the surgical procedure includes decompressing a neural element.

20. The method of claim 19 wherein decompressing a neural element includes decompressing any of an individual nerve root, a spinal cord, a cauda equine, or a combination thereof.

21. The method of claim 18 wherein the site in need of a medical procedure may include a portion or the whole of a herniated disc, an osteophyte, a thickened ligament, a tumor, a hematoma, a degenerative cyst, or any other compressing pathology.

22. The method of claim 18 further comprising providing an osteogenic agent within the repair implant before installing the repair implant for stimulating bone growth within the repair implant.

23. The method of claim 18 further comprising creating intimate contact between the bone tissue within the repair implant and bone tissue of the vertebral body.

24. The method of claim 18 wherein the perfusing step comprises compressing bone tissue inside the porous cage.

25. The method of claim 24 wherein the compressing step is at least partially performed after the porous cage has been placed inside the access channel.