EXPANDABLE VERTEBRAL BODY REPLACEMENT DEVICE AND METHOD

• US 20110319996A1
• Filed: 12/04/2009
• Published: 12/29/2011
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Barrall, Ben
• Granted Patent: US 8,632,592 B2
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: 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
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2002/30115 circular-O-shaped
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30584 filled with gas
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30738 Sleeves
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30843 Pyramidally-shaped
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/443 having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/4693 : hydraulic
• CPC Class Codes: A61F 2002/4694 : pneumatic
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

Vertebral body replacement apparatuses, systems, and methods are provided. In various examples, an implantable device is configured to be inserted between a first vertebral body and a second vertebral body. The implantable device includes a first endplate configured to contact the first vertebral body. A second endplate is configured to contact the second vertebral body. An expansion bladder is disposed between and coupled to the first endplate and the second endplate. The expansion bladder includes a first chamber and a second chamber. The first chamber and the second chamber are sealed from fluid communication with one another. An injection port is disposed through one of the first endplate or second endplate. The injection port includes a first channel in fluid communication with the first chamber and a second channel in fluid communication with the second chamber.

Claims

1. An implantable device for insertion between a first vertebral body and a second vertebral body, the implantable device comprising:

a first endplate configured to contact the first vertebral body;

a second endplate configured to contact the second vertebral body;

an expansion bladder disposed between and coupled to the first endplate and the second endplate, the expansion bladder including a first chamber and a second chamber, the first chamber and the second chamber being sealed from fluid communication with one another; and

an injection port disposed through one of the first endplate or second endplate, the injection port including a first channel in fluid communication with the first chamber and a second channel in fluid communication with the second chamber.

2. The implantable device of claim 1, wherein the second chamber surrounds the first chamber.

3. The implantable device of claim 1, wherein the second chamber is substantially concentrically disposed around the first chamber.

4. The implantable device of claim 1, wherein the expansion bladder is configured to expand with filling of at least one of the first and second chambers with a material, wherein expansion of the expansion bladder causes the first and second endplates to move apart from each other.

5. The implantable device of claim 4, wherein at least one of the first and second chambers is configured to be at least partially filled with saline.

6. The implantable device of claim 4, wherein at least one of the first and second chambers is configured to be at least partially filled with air.

7. The implantable device of claim 4, wherein at least one of the first and second chambers is configured to be at least partially filled with a structural support material.

8. The implantable device of claim 7, wherein the structural support material includes polymethylmethacrylate.

9. The implantable device of claim 1, wherein at least one of the first and second endplates is annular.

10. The implantable device of claim 9, wherein both of the first and second endplates are annular.

11. The implantable device of claim 10, wherein the first chamber of the expansion bladder is disposed at open areas of the annular first and second endplates.

12. The implantable device of claim 1, wherein the expansion bladder includes two or more first chambers.

13. The implantable device of claim 1, wherein the expansion bladder includes two or more second chambers.

14. A vertebral body replacement system comprising:

an implantable device for insertion between a first vertebral body and a second vertebral body, the implantable device comprising;

a first endplate configured to contact the first vertebral body;

a second endplate configured to contact the second vertebral body;

an expansion bladder disposed between and coupled to the first endplate and the second endplate, the expansion bladder including a first chamber and a second chamber, the first chamber and the second chamber being sealed from fluid communication with one another; and

an injection port disposed through one of the first endplate or second endplate, the injection port including a first channel in fluid communication with the first chamber and a second channel in fluid communication with the second chamber; and

a fill material introducer configured to fluidly communicate with at least one of the first and second channels to at least partially fill at least one of the first and second chambers with a material.

15. The vertebral body replacement system of claim 14, wherein the fill material introducer includes a first fill material introducer configured to fluidly communicate with the first channel to at least partially fill the first chamber with a first material and a second fill material introducer configured to fluidly communicate with the second channel to at least partially fill the second chamber with a second material.

16. The vertebral body replacement system of claim 15, wherein the first material includes an expansion fluid and the second material includes a structural support material.

17. The vertebral body replacement system of claim 14, wherein the second chamber surrounds the first chamber.

18. The vertebral body replacement system of claim 14, wherein the second chamber is substantially concentrically disposed around the first chamber.

19. The vertebral body replacement system of claim 14, wherein the expansion bladder is configured to expand with filling of at least one of the first and second chambers with the material, wherein expansion of the expansion bladder causes the first and second endplates to move apart from each other.

20. A method of vertebral body replacement, the method comprising:

inserting an implantable device between a first vertebral body and a second vertebral body, the implantable device including a first endplate configured to contact the first vertebral body, a second endplate configured to contact the second vertebral body, and an expansion bladder disposed between and coupled to the first endplate and the second endplate, the expansion bladder including a first chamber and a second chamber, the first chamber and the second chamber being sealed from fluid communication with one another;

introducing an expansion fluid into the first chamber of the expansion bladder to separate the first and second endplates of the implantable device to achieve a final height of the implantable device; and

introducing a structural support material into the second chamber of the expansion bladder to maintain the final height of the implantable device.

21. The method of claim 20, comprising evacuating the expansion fluid from the first chamber after introducing the structural support material into the second chamber of the expansion bladder.

22. The method of claim 21, comprising introducing a substance into the first chamber after evacuation of the expansion fluid.

23. The method of claim 22, wherein introducing the substance into the first chamber includes introducing a therapeutic substance into the first chamber.

24. The method of claim of claim 20, wherein introducing the expansion fluid includes separating the first and second endplates of the implantable device to cause the first endplate to contact the first vertebral body and to cause the second endplate to contact the second vertebral body.

25. A method of treatment of a spine including a damaged or diseased vertebral body disposed between first and second vertebral bodies, the method comprising:

providing an access channel to the spine;

removing the damaged or diseased vertebral body;

inserting, through the access channel, an implantable device between the first vertebral body and the second vertebral body, the implantable device including a first endplate configured to contact the first vertebral body, a second endplate configured to contact the second vertebral body, and an expansion bladder disposed between and coupled to the first endplate and the second endplate, the expansion bladder including a first chamber and a second chamber, the first chamber and the second chamber being sealed from fluid communication with one another;

introducing an expansion fluid into the first chamber of the expansion bladder to separate the first and second endplates of the implantable device to achieve a final height of the implantable device, wherein the first endplate is in contact with the first vertebral body and the second endplate is in contact with the second vertebral body; and

introducing a structural support material into the second chamber of the expansion bladder to maintain the final height of the implantable device.

26. The method of claim 25, comprising evacuating the expansion fluid from the first chamber after introducing the structural support material into the second chamber of the expansion bladder.

27. The method of claim 26, comprising introducing a substance into the first chamber after evacuation of the expansion fluid.

28. The method of claim 27, wherein introducing the substance into the first chamber includes introducing a therapeutic substance into the first chamber.

29. The method of claim 25, comprising sealing the access channel following insertion of the implantable device.

30. The method of claim 25, wherein inserting the implantable device includes inserting the implantable device with an initial height of the implantable device that is less than the final height.