Spinal stabilization systems and methods

• US 7,691,132 B2
• Filed: 11/21/2005
• Issued: 04/06/2010
• Est. Priority Date: 10/30/2002
• Status: Active Grant

• Current Assignee: Zimmer Biomet Spine, Inc. (Zimvie Incorporated)
• Original Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Landry, Michael E., Jones, Robert J., Wagner, Erik J., Forton, Charles R., Khoo, Larry T.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): SWIGER III, JAMES L
• Application Number:
  US11/284,282
• Publication Number:
  US 20060084993A1
• Time in Patent Office: 1,597 Days
• Field of Search: 606246-279, 606/104, 606/60, 606/99, 606/86.A, 606/914, 606/916, 606300-301, 606/305
• US Class Current: 606/279
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1655 for tapping
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/701 Longitudinal elements with a non-circular, e.g. rectangular, cross-section A61B17/7005, A61B17/7007 take precedence
• CPC Class Codes: A61B 17/7011 Longitudinal element being non-straight, e.g. curved, angled or branched adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7035 Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped
• CPC Class Codes: A61B 17/708 with tubular extensions coaxially mounted on the bone anchors
• CPC Class Codes: A61B 17/7082 for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws driving other bone screws A61B17/8875
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/7085 for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
• CPC Class Codes: A61B 17/7091 for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/861 specially shaped for gripping driver
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8875 : Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/8897 : Guide wires or guide pins
• CPC Class Codes: A61B 2017/0256 : for the spine
• CPC Class Codes: A61B 2090/031 : torque limiting
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: Y10S 606/914 : Toolkit for installing or removing spinal positioner or stabilizer

Abstract

A spinal stabilization system may be formed in a patient. In some embodiments, a minimally invasive procedure may be used to form a spinal stabilization system in a patient. Bone fastener assemblies may be coupled to vertebrae. Each bone fastener assembly may include a bone fastener and a collar. The collar may be rotated and/or angulated relative to the bone fastener. Detachable members may be coupled to the collar to allow for formation of the spinal stabilization system through a small skin incision. The detachable members may allow for alignment of the collars to facilitate insertion of an elongated member in the collars. An elongated member may be positioned in the collars and a closure member may be used to secure the elongated member to the collars.

Claims

1. A method for inserting a spinal stabilization system in a human spine, comprising:

making an incision in skin near human vertebrae to be stabilized;

pulling the incision toward a first one of the human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to the first human vertebra;

pulling the incision toward a second one of the human vertebrae to be stabilized;

inserting a second bone fastener assembly in the incision and securing the second bone fastener assembly to the second human vertebra;

creating a tissue plane between the first bone fastener assembly and the second human vertebra to be stabilized; and

releasing the incision before creating the tissue plane.

2. The method of claim 1, wherein the incision is made in skin above and substantially between the human vertebrae to be stabilized.

3. The method of claim 1, wherein insertion angles of the bone fastener assemblies are determined by patient anatomy.

4. The method of claim 1, wherein the tissue plane is substantially trapezoidal.

5. The method of claim 1, further comprising using an estimating tool to estimate a length of an elongated member needed to couple the bone fastener assemblies.

6. The method of claim 1, wherein the first bone fastener assembly is coupled to a first sleeve, and wherein the second bone fastener assembly is coupled to a second sleeve.

7. The method of claim 6, wherein an angle of at least one of the sleeves relative to a surface of the skin may be adjusted to maintain a size of the incision.

8. The method of claim 6, further comprising guiding an elongated member down channels in the sleeves, through the incision, and through a tissue plane toward the bone fastener assemblies.

9. The method of claim 8, further comprising bending the elongated member before inserting the elongated member in the sleeves, wherein the elongated member is bent to inhibit increasing a length of the incision.

10. The method of claim 6, wherein an adjustable positioner is used to guide an elongated member down the sleeves, through a tissue plane, and into the bone fastener assemblies.

11. The method of claim 10, further comprising rotating the elongated member subcutaneously to position the elongated member in the bone fastener assemblies.

12. The method of claim 11, wherein the elongated member is rotated subcutaneously without visualization.

13. The method of claim 6, further comprising securing an elongated member to the bone fastener assemblies.

14. The method of claim 6, further comprising securing an elongated member to each bone fastener assembly with a closure member and counter torquing at least one of the sleeves above the incision while a tool portion of a closure member is sheared off.

15. The method of claim 6, further comprising removing the sleeves from the bone fastener assemblies from above the incision.

16. The method of claim 1, further comprising inserting an elongated member in the bone fastener assemblies and securing the elongated member to the bone fastener assemblies with closure members.

17. A method for inserting a spinal stabilization system in a human spine, the method comprising:

making an incision in skin near human vertebrae to be stabilized;

pulling the incision toward a first one of the human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to the first human vertebra, wherein the first bone fastener assembly is coupled to a first sleeve;

pulling the incision toward a second one of the human vertebrae to be stabilized; and

inserting a second bone fastener assembly in the incision and securing the second bone fastener assembly to the second human vertebra, wherein the second bone fastener assembly is coupled to a second sleeve;

wherein relative movement of the sleeves is substantially unconstrained prior to insertion of an elongated member.

18. A method for inserting a spinal stabilization system in a human spine, the method comprising:

making an incision in skin near human vertebrae to be stabilized;

pulling the incision toward a first one of the human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to the first human vertebra, wherein the first bone fastener assembly is coupled to a first sleeve;

pulling the incision toward a second one of the human vertebrae to be stabilized; and

inserting a second bone fastener assembly in the incision and securing the second bone fastener assembly to the second human vertebra, wherein the second bone fastener assembly is coupled to a second sleeve;

wherein the sleeves cross substantially at or near the incision following insertion of the bone fastener assemblies.

19. A method for inserting a spinal stabilization system in a human spine, the method comprising:

making an incision in skin near human vertebrae to be stabilized;

pulling the incision toward a first one of the human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to the first human vertebra, wherein the first bone fastener assembly is coupled to a first sleeve;

pulling the incision toward a second one of the human vertebrae to be stabilized;

inserting a second bone fastener assembly in the incision and securing the second bone fastener assembly to the second human vertebra, wherein the second bone fastener assembly is coupled to a second sleeve; and

initially inserting an elongated member substantially longitudinally down one of the sleeves.

20. A method for inserting a spinal stabilization system in a human spine, comprising:

making an incision in skin near human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to a first one of the human vertebrae to be stabilized, wherein the first bone fastener assembly is coupled to a first sleeve;

creating a substantially trapezoidal tissue plane near the human vertebrae to be stabilized, wherein the substantially trapezoidal plane has a dimension near the human vertebrae that is larger than the opposite dimension near the incision;

securing a second bone fastener assembly to a second one of the human vertebrae to be stabilized, wherein the second bone fastener assembly is coupled to a second sleeve;

inserting a first end region of an elongate member in a passage of the first sleeve and a second end region of the elongate member in a passage of the second sleeve; and

after the first end region of the elongate member is inserted into the passage of the first sleeve and the second end region of the elongate member is inserted into the passage of the second sleeve, moving the elongate member through the passages of the first sleeve and the second sleeve to position the first end region of the elongate member in a slot of the first bone fastener assembly and the second end region of the elongate member in a slot of the second bone fastener assembly.

21. The method claim 20, wherein the incision is made above and substantially between the human vertebrae to be stabilized.

22. The method claim 20, further comprising moving the incision to create the substantially trapezoidal tissue plane.

23. The method claim 20, wherein the human vertebrae to be stabilized comprise two human vertebrae, and wherein the substantially trapezoidal plane is near the two human vertebrae.

24. The method claim 20, wherein the human vertebrae to be stabilized comprise three human vertebrae, and wherein the substantially trapezoidal plane is near the three human vertebrae.

25. The method claim 20, further comprising securing inserting a third bone fastener assembly to a third one of the human vertebrae to be stabilized.

26. A method for inserting a spinal stabilization system in a human spine, comprising:

making an incision near human vertebrae to be stabilized;

inserting a first bone fastener assembly in the incision and securing the first bone fastener assembly to a first one of the human vertebrae, wherein a first sleeve is coupled to the first bone fastener assembly;

creating a tissue plane between the first bone fastener assembly and another one of the human vertebrae to be stabilized;

securing one or more other bone fastener assemblies to another one of the human vertebrae to be stabilized, wherein at least one second sleeve is coupled to at least one of the one or more other bone fastener assemblies;

inserting a first end region of the elongated member in at least one channel in the first sleeve and a second end region of the elongate member in at least one channel in the second sleeve; and

after inserting the first end region of the elongate member in at least one channel in the first sleeve and the second end region of the elongate member in at least one channel in the second sleeve, advancing the elongated member through the incision and/or tissue plane toward the bone fastener assemblies.

27. The method of claim 26, wherein a shape of the tissue plane is substantially trapezoidal.

28. The method of claim 26, further comprising securing the elongated member to the bone fastener assemblies.

29. The method of claim 26, further comprising securing an elongated member to each bone fastener assembly with a closure member and counter torquing at least one of the sleeves above the incision while a tool portion of a closure member is sheared off.

30. The method of claim 26, further comprising removing the sleeves from the bone fastener assemblies from above the incision.

31. A method of inserting a spinal stabilization system in a human spine, comprising:

making an incision in skin near human vertebrae to be stabilized;

inserting a first bone fastener assembly coupled to a first sleeve in the incision and securing the first bone fastener assembly to a first one of the human vertebrae;

allowing the incision to determine an angle of the first sleeve relative to a bone fastener of the first bone fastener assembly;

creating a tissue plane between the first sleeve and another one or more of the human vertebrae to be stabilized;

inserting one or more other bone fastener assemblies, each coupled to a sleeve, in the incision and securing each of the other bone fastener assemblies to another one of the human vertebrae to be stabilized; and

guiding an elongated member down at least one channel in at least one of the sleeves, through the incision, and though the tissue plane toward the bone fastener assemblies.

32. The method of claim 31, further comprising moving the incision toward the first one of the human vertebrae to be stabilized before inserting the first bone fastener assembly.

33. The method of claim 31, further comprising using the first sleeve to move the incision toward the first one of the human vertebrae to be stabilized before inserting the first bone fastener assembly.

34. The method of claim 31, wherein the tissue plane has a substantially trapezoidal shape.

35. The method of claim 31, further comprising advancing the elongated member through the tissue plane without visualization.

36. The method of claim 31, further comprising rotating the elongated member subcutaneously without visualization and securing the elongated member to the bone fastener assemblies.