Minimally invasive fixation system

• US 7,758,584 B2
• Filed: 04/11/2007
• Issued: 07/20/2010
• Est. Priority Date: 04/11/2006
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Rossney, Mark, Bankoski, Brian R., Bundra, Caryn E., Woodburn, William N. Sr., Solitario, Ralph C. Jr., McDivitt, Eric, Hanson, Shaun, Rathbun, David
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): NEGRELLI, CHRISTINA L
• Application Number:
  US11/734,201
• Publication Number:
  US 20070270842A1
• Time in Patent Office: 1,196 Days
• Field of Search: 606/61, 606/86, 606/104, 606/246, 606/96, 606/99, 606264-279, 606300-321
• US Class Current: 606/104
• 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 17/7076 for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
• CPC Class Codes: A61B 17/7079 Tools requiring anchors to be already mounted on an implanted longitudinal or transverse element, e.g. where said element guides the anchor motion
• 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 17/865 Packages or dispensers for bone screws or threaded wires
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

A minimally invasive fixation system and method for providing access to a surgical site. The fixation system may include a holding assembly, the holding assembling preferably including a lateral implant holder which may be attached to a pedicle screw and a sleeve positioned in connection with the lateral implant holder to prevent the lateral implant holder from separating from the pedicle screw. The sleeve may further include a tissue protection portion to keep the tissue out of the surgical site. A holding sleeve may be operably connected to the holding assembly and pedicle screw and may be used to insert the pedicle screw into the body. Multiple constructs may be inserted into the body so that a portion of the holding assembly extends from the body and provides access to and visualization of the surgical site. A rod holder may also be used to insert a rod into the head of the screw. The rod may be held by the rod holder so that the rod may be angulated as the rod is inserted into the screw heads. Once the rod is positioned in the screw heads, locking caps and/or set screws may be positioned over the rod and engage the screw heads so that the position of the rod may be fixed with respect to the screws. In some embodiments, a movement mechanism may be used to move the screws relative to each other to compress and/or distract the vertebrae.

Claims

1. A fixation system comprising:

a first bone anchor having a first U-shaped channel, the first bone anchor being sized and configured to be selectively insertable into a first bone tissue;

a second bone anchor having a second U-shaped channel, the second bone anchor being sized and configured to be selectively insertable into a second bone tissue;

a first holding assembly comprising a first lateral implant holder and a first sleeve, the first lateral implant holder having a distal end sized and configured to selectively receive the first bone anchor, the first sleeve having a distal end, a first tissue protection portion, and a first passageway sized and configured to selectively receive the first lateral implant holder; and

a second holding assembly comprising a second lateral implant holder and a second sleeve, the second lateral implant holder having a distal end sized and configured to selectively receive the second bone anchor, the second sleeve having a distal end, a second tissue protection portion, and a second passageway sized and configured to selectively receive the second lateral implant holder;

wherein the first tissue protection portion includes a first helical shaped cutout and the second tissue protection portion includes a second helical shaped cutout, the first and second helical shaped cutouts being sized and configured to permit the first and second tissue protection portions to intermesh so that an opening is created to enable a rod to be inserted through the opening and into the first and second U-shaped channels of the first and second bone anchors, respectively.

2. The fixation system of claim 1, wherein the first helical shaped cutout of the first tissue protection portion spirals in a first direction.

3. The fixation system of claim 2, wherein the second helical shaped cutout of the second tissue protection portion spirals in a second direction which is different from the first direction.

4. The fixation system of claim 1, wherein the first helical shaped cutout extends in a first direction and the second helical shaped cutout extends in a second direction different from the first direction.

5. The fixation system of claim 1, wherein each of the distal ends of the first and second lateral implant holders has a receiving assembly for selectively receiving one of the bone anchors.

6. The fixation system of claim 5, wherein the receiving assembly has a plurality of selectively displaceable arms, the receiving assembly having a first position wherein the bone anchor can be inserted or removed from the receiving assembly, the receiving assembly having a second position wherein the bone anchor is retained by the receiving assembly.

7. The fixation system of claim 6, wherein, in the second position, the distal end of the sleeve is positioned proximate the distal end of its respective lateral implant holder to secure the bone anchor to the lateral implant holder.

8. The fixation system of claim 7, further comprising a mechanism for selectively moving the sleeve relative to the lateral implant holder.

9. The fixation system of claim 1, wherein the distal end of first lateral implant holder has a chamfered portion.

10. The fixation system of claim 1 further comprising a holding sleeve constructed and arranged to be operably associated with one of the holding assemblies.

11. The fixation system of claim 10, wherein the holding sleeve comprises a handle and an elongated member.

12. The fixation system of claim 11, wherein the elongated member has a distal end constructed and arranged to selectively contact the bone anchor such that the bone anchor is not pivotable relative to at least one of the lateral implant holder and the sleeve.

13. The fixation system of claim 12, wherein the distal end of the elongated member has a plurality of selectively displaceable arms, the arms being displaceable relative to each other.

14. The fixation system of claim 12, wherein the elongated member has a passageway therethrough, the passageway being sized and configured to receive a driving mechanism.

15. The fixation system of claim 14, wherein the driving mechanism is constructed and arranged to engage the bone anchor to drive the bone anchor into the bone tissue.

16. The fixation system of claim 1 further comprising a loading station, wherein the loading station has a base and a sliding platform, the sliding platform constructed and arranged to engage with at least one of the lateral implant holder and sleeve.

17. The fixation system of claim 1 further comprising a rod holder having an elongated body, a shaft housed within the elongated body, and a retaining assembly constructed and arranged to selectively retain a rod, wherein the shaft is displaceable between a first position wherein the rod can be retained and a second position wherein the rod can be released.

18. The fixation system of claim 17 wherein the retaining assembly includes a displaceable bar, wherein the shaft pushes the bar toward the rod such that the bar contacts the rod when the shaft is in the first position.

19. The fixation system of claim 17, wherein the rod holder further includes a handle constructed and arranged to move the shaft between the first position and the second position.

20. The fixation system of claim 17, wherein the rod holder further includes a handle having a first member attached to the shaft and a second member attached to the elongated body, such that the displacement of the first member with respect to the second member selectively moves the shaft between the first position and the second position.

21. The fixation system of claim 17, wherein the retaining assembly includes a slot, wherein the rod includes an end portion constructed and arranged to be received by the slot.

22. The fixation system of claim 18, wherein the rod includes a projection and the retaining assembly includes an aperture for receiving the projection.

23. The fixation system of claim 1 further comprising a rod holder comprising an elongated body operably associated with an articulating portion, the articulating portion pivotally connected to the elongated body, the articulating portion constructed and arranged to engage the rod.

24. The fixation system of claim 23, wherein the elongated body of the rod holder has an outer elongated member and an inner elongated member moveable relative to the outer elongated member.

25. The fixation system of claim 24, wherein the articulating member is selectively pivotable relative to the outer elongated member, the inner elongated member engaging a surface of the articulating portion to prevent pivoting of the articulating portion relative to the outer elongated member.

26. The fixation system of claim 24, wherein a biasing member is positioned between and operably associated with the inner and outer elongated members so that the inner elongated member is biased away from the articulating portion.

27. The fixation system of claim 23, wherein the articulating portion has a engagement device having a protrusion which selectively engages a recess in the rod, the articulating portion further including a biasing member for maintaining the protrusion in the recess.

28. The fixation system of claim 27, the rod holder further comprising a shaft for moving the protrusion out of the recess, wherein the articulating portion has a passageway through which the shaft moves when the articulating portion is substantially perpendicular to the elongated body.

29. The fixation system of claim 1 further comprising a movement mechanism for moving the first bone anchor relative to the second bone anchor.

30. The fixation system of claim 29, wherein the movement mechanism has a first member for contacting the first bone anchor, a second member for contacting the second bone anchor, and a bar extending from the first member, the second member being displaceable relative to the bar, wherein upon displacement of the second member relative to the bar results in the displacement of the second member relative to the first member.

31. The fixation system of claim 30, wherein the movement mechanism further comprises an actuation mechanism constructed and arranged to move along the bar, the actuation mechanism being operably associated with the second member and the bar to move the second member as the actuation mechanism moves along the bar.

32. The fixation system of claim 31, wherein the actuation mechanism further comprises a locking mechanism.

33. The fixation system of claim 31, wherein the bar has teeth and the actuation mechanism has a knob and a gear, the knob contacting the gear and the gear contacting the teeth such that rotation of the knob moves the gear along the teeth.

34. The fixation system of claim 31, wherein the second member is shaped so that movement of the actuation mechanism toward the first member cause the first and second bone anchors to move apart and movement of the actuation mechanism away from the first member cause the first and second bone anchors to move together.

35. The fixation system of claim 30, wherein the second member is see-saw shape and is pivotally connected to the first member.

36. The fixation system of claim 30, wherein the first member has a bore therethrough sized and configured to receive an instrument.

37. The fixation system of claim 30, wherein the movement mechanism further comprises a third member operably associated with the second member, the second and third members constructed and arranged such that movement of the third member towards the first member causes a distal end of the second member to move towards the first member.

38. The fixation system of claim 37, wherein the second and third members are pivotally coupled to the first member.

39. The fixation system of claim 30, wherein the bar has a locking mechanism to fix the orientation of the first and second member relative to each other.

40. A minimally invasive fixation system comprising:

a first bone anchor having a first U-shaped channel, the first bone anchor being sized and configured for insertion into a first bone;

a second bone anchor having a second U-shaped channel, the second bone anchor being sized and configured for insertion into a second bone;

a first holding assembly comprising a first sleeve having a distal end and a longitudinal axis, the first sleeve has a first tissue protection portion extending partially around the longitudinal axis of the first sleeve; and

a second holding assembly comprising a second sleeve having a distal end and a longitudinal axis, the second sleeve has a second tissue protection portion extending partially around the longitudinal axis of the second sleeve;

wherein the first tissue protection portion includes a first helical shaped cutout and the second tissue protection portion includes a second helical shaped cutout, the first and second helical shaped cutouts being sized and configured to permit to permit the first and second tissue protection portions to intermesh so that an opening is created to enable a rod to be inserted through the opening and into the first and second U-shaped channels of the first and second bone anchors, respectively.

41. The minimally invasive fixation system of claim 40, wherein the first helical shaped cut out extends in a first direction and the second helical shaped cut out extends in a second direction opposite to the first direction.

42. A method for implanting a rod into first and second U-shaped channels formed in first and second bone anchors, respectively, the method comprising:

coupling a first holding assembly to the first bone anchor, the first holding assembling including a first lateral implant holder each lateral implant holder having a distal end and a receiving portion at the distal end for receiving the first bone anchor, the first holding assembling further including a first, the first sleeve having a distal end sized and configured to contact the receiving portion of the first lateral implant holder and a first tissue protection portion having a first helical shaped cutout;

coupling a second holding assembly to the second bone anchor, the second holding assembling including a second lateral implant holder having a distal end and a receiving portion at the distal end for receiving the second bone anchor, the second holding assembling further including a second sleeve, the second sleeve having a distal end sized and configured to contact the receiving portion of the second lateral implant holder and a second tissue protection portion having a second helical shaped cutout;

moving the first and second sleeves from a first position on the first and second lateral implant holders, respectively, wherein the first and second bone anchors can be removed from the first and second lateral implant holders, respectively, to a second position on the first and second lateral implant holders, respectively, wherein the first and second bone anchors are retained by the first and second lateral implant holders, respectively;

inserting the first and second bone anchors, lateral implant holders and sleeves into a patient'"'"'s body through an incision in the body via a driving mechanism;

aligning the first and second helical shaped cutouts to permit the first and second tissue protection portions to create an opening;

inserting a rod through the incision and into the opening in a first rod position and moving the rod into a second rod position as the rod is inserted into the first and second U-shaped channels; and

fixing the rod with respect to the first and second bone anchors.