Methods of spinal fixation and instrumentation

• US 20070078460A1
• Filed: 08/25/2005
• Published: 04/05/2007
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Schnider, Martin, Frigg, Robert, Schwer, Stefan
• Granted Patent: US 7,909,830 B2
• Time in Patent Office: Days
• US Class Current: 606/86.A
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• 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 17/7037 wherein pivoting is blocked when the rod is clamped
• 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

Abstract

A method for performing spinal fixation and instrumentation. A first incision may be made through the skin and a passageway may be created to the spine. A screw may be inserted through the passageway and into a vertebrae. The screw may have a head portion including a channel. An insertion guide may be operable connected to the screw. The insertion guide may have first and second longitudinal slots. Additional screws may each be inserted through separate incisions or through the first incision. Insertion guides may be operably connected to a head portion of each screw. A sleeve may be positioned into one insertion guide in a first position to guide a rod through at least one other insertion guide. The sleeve may be rotated to a second position to allow the rod to move down the slots of the insertion guide(s) and into the head portion of the screw.

Claims

1. An insertion guide comprising:

a first section having a distal end, a proximal end, a first longitudinal slot extending from the distal end towards the proximal end, and at least one protrusion; and

a second section having distal end, a proximal end, a second longitudinal slot extending from the distal end towards the proximal end, and at least one recess for receiving the at least one protrusion, wherein the second section is connectable to the first section such that the second longitudinal slot is diametrically opposed to the first longitudinal slot;

wherein the distal ends of the first and second sections when operably connected to each other are sized and configured to engage a head portion of a screw and wherein the first and second sections engage each other to form a tube having a bore therethrough.

2. The guide of claim 1, wherein the distal end of at least one of the first and second

sections has a flange and at least one prong extending from the flange into the bore, and wherein the flange is sized and configured to be inserted into a groove in the head portion of the screw and the at least one prong is sized and configured to engage at least one surface of the head portion of the screw to prevent rotation of the insertion guide with respect to the screw.

3. The guide of claim 1, wherein at least one of the first and second sections has a ring member positioned proximate at the proximal end of the tube.

4. The guide of claim 1, wherein at least one slot is positioned between the first and second longitudinal slots, wherein the first and second longitudinal slots and the at least one slot forms a plurality of arms sized and configured to engage a head portion of a screw.

5. A system for performing spinal fixation comprising:

an insertion guide having an elongated body, a proximal end, a distal end, a first longitudinal slot, a second longitudinal slot and a bore therethrough, wherein the first and second longitudinal slots extend from the distal end towards the proximal end of the tube; and

a sleeve having an elongated body having a side wall, a proximal end, a distal end, a first longitudinal opening in the side wall, a second longitudinal opening in the side wall and a passageway extending from the distal end to the proximal end, the guide sleeve being sized and configured to fit within the bore of the insertion guide, the guide sleeve having a first position in the insertion guide wherein the first longitudinal opening of the guide sleeve is aligned with the first longitudinal slot of the insertion guide and the second longitudinal opening of the guide sleeve is aligned with the second longitudinal slot of the insertion guide and a second position in the insertion guide wherein the first longitudinal opening of the guide sleeve is not aligned with the first longitudinal slot of the insertion guide and the second longitudinal opening of the guide sleeve is not aligned with the second longitudinal slot of the insertion guide.

6. The system of claim 5, wherein the first longitudinal opening extending a first distance from the distal end towards the proximal end and the second longitudinal opening is diametrically opposed to the first longitudinal opening and extending a second distance from the distal end towards the proximal end, wherein the second distance is less than the first distance, the sleeve further comprising a first opening in the side wall intersecting the first longitudinal opening at an angle and a second opening in the side wall intersecting the second longitudinal opening at an angle.

7. The system of claim 6 further comprising an elongated fixation member sized and

configured to be inserted through the first and second longitudinal slots of the insertion guide and the first and second longitudinal openings of the sleeve.

8. The system of claim 7 further comprising a holding instrument for engaging the elongated fixation member.

9. A sleeve for positioning relative to an insertion guide comprising:

an elongated, generally cylindrical shaped body having a side wall, a distal end, a proximal end, and a passageway extending from the distal end to the proximal end;

a first longitudinal opening in the side wall extending a first distance from the distal end towards the proximal end;

a second longitudinal opening in the side wall diametrically opposed to the first longitudinal opening and extending a second distance from the distal end towards the proximal end, wherein the second distance is less than the first distance; and

a first opening in the side wall intersecting the first longitudinal opening at an angle and a second opening in the side wall intersecting the second longitudinal opening at an angle;

wherein the first and second longitudinal openings and first and second openings are sized to receive an elongated fixation member.

10. The sleeve of claim 9, wherein the first opening intersects the first longitudinal opening at a substantially perpendicular angle, and wherein the second opening intersects the second longitudinal opening at a substantially perpendicular angle.

11. The sleeve of claim 9, wherein the insertion guide comprises an elongated body having an passageway, a first longitudinal slot and a second longitudinal slot, wherein the sleeve is sized and configured to be positioned into the passageway of the insertion guide so that in a first position, the first and second openings of the sleeve are accessible through the first and second longitudinal slots of the insertion guide, respectively, and in a second position, the first and second longitudinal openings of the sleeve align with the first and second longitudinal slots of the insertion guide, respectively.

12. The sleeve of claim 11, wherein the first longitudinal opening and the first opening form a generally L-shape opening and the second longitudinal opening and the second opening form a generally L-shape opening.

13. A device used to perform spinal fixation comprising:

an elongated rod having an axis, a distal end, a proximal end, and a receiving portion at the proximal end; and

a holding instrument having an axis and comprising;

an outer member having a distal end, a proximal end, an attachment portion proximate the distal end, and a passageway extending from the proximal end to the distal end, wherein the attachment portion is positionable into the receiving portion of the rod; and

an inner member having a distal end, a proximal end, and a tip at the proximal end, wherein the inner member is sized and configured for insertion through the passageway of the outer member so that the distal end of the inner member is positionable within the attachment portion;

wherein the elongated rod and holding instrument are attachable to each other so that the elongated rod and holding instrument are moveable between a first position and a second position with respect to each other, wherein, in the first position, the axis of the elongated rod is aligned with the axis of the holding instrument and, in the second position, the axis of the elongated rod is at an angle with respect to the axis of the holding instrument.

14. The device of claim 13, wherein the receiving portion of the rod has at least one bore and the tip of the inner member is positionable within that at least one bore to fix the orientation of the holding instrument relative to the rod.

15. The device of claim 13, wherein the outer member has a threaded portion inside the passageway and the inner member has corresponding threads on an outer surface of the inner member for engaging the threaded portion of the outer member so that rotation of the inner member relative to the outer member moves the inner member axially in the passageway.

16. The device of claim 13, wherein the attachment portion comprises a pair of arms for engaging the receiving portion.

17. The device of claim 16, wherein the receiving portion has at least two bores for receiving the pair of arms of the outer member such that when the distal portion of the inner member is inserted in between the arms, at least a portion of the each arm is positioned into a bore to hold the elongated rod relative to the holding instrument.

18. The device of claim 17, wherein the arms have a hemispherical shaped portion received in the bore.

19. A device used to perform spinal fixation comprising:

an elongated rod having an axis, a distal end, a proximal end, and an engagement portion at the proximal end; and

a holding instrument having an axis and comprising;

an outer sleeve having a distal end, a proximal end and a passageway therethrough; and

an inner sleeve having a distal end and a proximal end, wherein the inner sleeve is positioned within the passageway of the outer sleeve;

wherein the distal end of the outer sleeve is selectively moveable over the distal end of the inner sleeve, and wherein the inner sleeve has a portion at the distal end for engaging the engagement portion of the elongated rod;

wherein the elongated rod and holding instrument are attachable to each other so that the elongated rod and holding instrument are moveable between a first position and a second position with respect to each other, wherein, in the first position, the axis of the elongated rod is aligned with the axis of the holding instrument and, in the second position, the axis of the elongated rod is at an angle with respect to the axis of the holding instrument.

20. The device of claim 19, wherein the portion at the distal end of the inner sleeve comprises at least two prongs.

21. The device of claim 20, wherein the inner sleeve has external threads and the passageway of the outer sleeve has internal threads for engaging the external threads of the inner sleeve so that the distal end of the outer sleeve is moveable along the axis of the holding instrument so that the distal end of the outer sleeve is positionable over the at least two prongs to fix the prongs relative to the engagement portion of the elongated rod.

22. The device of claim 21, wherein the engagement portion of the elongated rod has at least one protrusion and the at least two prongs each have at least one recess for receiving the at least one protrusion.

23. The device of claim 19 further comprising an elongated member positioned within the inner sleeve and moveable therein, the elongated member having a distal end, a proximal end, a guide member and a taper portion at the distal end.

24. The device of claim 23, wherein the tapered portion of the elongated member has

a point and the engagement portion of the rod has at least one receiving portion for receiving the point of the elongated member, wherein positioning the point in the receiving portion fixes the orientation of the elongated rod relative to the holding instrument.

25. The device of claim 23, wherein the elongated member is made of a material which is harder than a material of the engagement portion of the elongated rod.

26. The device of claim 23, wherein the holding instrument further comprises an actuation mechanism for engaging the outer sleeve.

27. The device of claim 26, wherein the actuation mechanism comprises a first passageway therethrough having a first dimension, wherein the first passageway is sized and configured to receive the proximal end of the outer sleeve.

28. The device of claim 27, wherein the actuation mechanism comprises a second passageway therethrough having a second dimension, wherein the second passageway intersects the first passageway and wherein the second dimension is less than the first dimension, thereby forming a shoulder in the actuation mechanism.

29. The device of claim 28, wherein the guide member of the elongated member is inserted in at least one slot in the inner sleeve so that the elongated member moves axially but not rotationally relative to the inner sleeve.

30. The device of claim 29, wherein the guide member is positioned between the proximal end of the outer sleeve and the shoulder of the actuation mechanism.

31. The device of claim 30, wherein the actuation mechanism has a retaining member,

the retaining member having a distal end, a proximal end, an outer surface, a knob at the proximal end and a notch in between the distal and the proximal ends, wherein the retaining member is rotatable within a bore in the actuation mechanism.

32. The device of claim 31, wherein the outer sleeve has a recess for selectively receiving the outer surface of the retaining member so that the outer sleeve is fixed with respect to the retaining member and the actuation mechanism, and wherein, in a fixed position, the actuation mechanism is used to move the outer sleeve and elongated member with respect to the inner sleeve.

33. The device of claim 32, wherein the outer sleeve is freely moveable with respect to the inner sleeve when the notch of the retaining member faces the recess of the outer sleeve.

34. The device of claim 33, wherein the actuation mechanism further comprise a holding member positioned therethrough, the holding member having a portion for engaging at least one receiving portion of the retaining member so that the retaining member is held in various fixed positions relative to the actuation mechanism and outer sleeve.

35. The device of claim 19, wherein the engagement portion of the elongated rod is spherical in shape and the inner sleeve having a plurality of arms at the distal end of the inner sleeve for engaging the engagement portion.

36. The device of claim 19, wherein the engagement portion of the elongated rod has a plurality of flat surfaces and the inner sleeve has at least two prongs at the distal end of the inner sleeve, wherein the at least two prongs each has at least one pin.

37. The device of claim 36, wherein the at least one pin is made of a material which is harder than a material of the engagement portion of the elongated rod.

38. A sleeve for positioned relative to an insertion guide comprising:

an elongated, generally cylindrical shaped body having a side wall, a distal end, a proximal end, and a passageway extending from the distal end to the proximal end;

a first spiral opening in the side wall extending a first distance from the distal end towards the proximal end; and

a second spiral opening in the side wall extending a second distance from the distal end towards the proximal end, wherein the second distance is less than the first distance;

wherein the first and second spiral openings are sized to receive an elongated fixation member.

39. A method for performing spinal fixation comprising:

making a first incision in skin;

creating a passageway to the spine through the incision;

inserting a first screw through the passageway, the first screw having a shaft for insertion in a vertebrae and a head portion operably connected to the shaft;

providing a first insertion guide, the first insertion guide having a proximal end, a distal end, a first longitudinal slot, a second longitudinal slot and a passageway therethrough;

inserting the first insertion guide through the passageway;

connecting the distal end of the first insertion guide to the head portion of the first screw;

providing a sleeve comprising;

an elongated body;

a first longitudinal opening extending from a first distance from the distal end towards the proximal end;

a second longitudinal opening diametrically opposed to the first slot and extending a second distance from the distal end towards the proximal end, wherein the second distance is less than the first distance; and

a first opening intersecting the first longitudinal opening at an angle and a second opening intersecting the second longitudinal opening at an angle;

inserting the sleeve through the passageway of the at least one insertion guide and positioned the sleeve in the passageway so that the first and second openings are accessible through the first and second longitudinal slots of the first insertion guide;

providing an elongated rod having a proximal end and a distal end;

inserting the elongated rod through the first and second longitudinal slots of the insertion guide and through the first and second openings of the sleeve;

moving the elongated rod through the first and second openings and the first and second longitudinal slots so that the rod traverses a head of a second screw;

rotating the sleeve so that the first longitudinal opening is aligned with the first longitudinal slot and the second longitudinal opening is aligned with the second longitudinal slot; and

moving the elongated rod toward the distal end of the first insertion guide and into the head portion of the first screw.

40. The method of claim 39 further comprising:

making a second incision in skin;

creating a second passageway to the spine through the second incision;

inserting a second screw through the second passageway, the second screw having a shaft for insertion in a vertebrae and a head portion operably connected to the shaft;

providing a second insertion guide, the second insertion guide having a proximal end, a distal end, a first longitudinal slot, a second longitudinal slot and a passageway therethrough, wherein the distal end of the second insertion guide is operably connected to the head portion of the second screw;

inserting the second insertion guide through the second passageway;

inserting the elongated rod through the first and second longitudinal slots of the second insertion guide; and

moving the elongated rod toward the distal end of the second insertion guide and into the head portion of the second screw.

41. The method of claim 40 further comprising:

making a third incision in skin;

creating a third passageway to the spine through the third incision;

inserting a third screw through the third passageway, the third screw having a shaft for insertion in a vertebrae and a head portion operably connected to the shaft;

providing a third insertion guide, the third insertion guide having a proximal end, a distal end, a first longitudinal slot, a second longitudinal slot and a passageway therethrough, wherein the distal end of the third insertion guide is operably connected to the head portion of the third screw;

inserting the third insertion guide through the third passageway; and

inserting the elongated rod through the first and second longitudinal slots of the third insertion guide.

42. The method of claim 40 further comprising:

providing a holding instrument;

operably engaging the holding instrument to the proximal end of the elongated rod; and

inserting the holding instrument through the first incision and into the passageway.

43. The method of claim 39 further comprising:

inserting at least one additional screw through the passageway, the at least one additional screw having a shaft for insertion in a vertebrae and a head portion operably connected to the shaft;

providing at least on additional insertion guide, the at least one additional insertion guide having a proximal end, a distal end, a first longitudinal slot, a second longitudinal slot and a passageway therethrough, wherein the distal end of the at least one additional insertion guide is operably connected to the head portion of the at least one additional screw;

inserting the at least one additional insertion guide through the passageway;

inserting the elongated rod through the first and second longitudinal slots of the at least one additional insertion guide; and

moving the elongated rod toward the distal end of the at least one additional insertion guide and into the head portion of the at least one additional screw.

44. An insertion guide comprising:

an inner sleeve comprising a distal end, a proximal end, a bore extending from the distal end to the proximal end, a body, first and second arms extending from the body, first and second longitudinal slots positioned between the arms, and an actuating mechanism positioned along the body; and

an outer sleeve comprising a distal end, a proximal end and an engagement member, the outer sleeve having a first position where the proximal end of the outer sleeve is positioned a first distance from the proximal end of the inner sleeve and a second position where the proximal end of the outer sleeve is positioned a second distance from the proximal end of the inner sleeve, wherein the second distance is greater than the first distance;

wherein the outer sleeve is positioned over the inner sleeve so that the engagement member of the outer sleeve engages the actuating mechanism of the inner sleeve for moving the outer sleeve between the first and second position.

45. A method of attaching an insertion guide to a screw comprising:

providing a screw having a shaft and a head portion, wherein the head portion has a channel therethrough;

providing a holder comprising a body, an opening through the body for receiving the screw, a ledge and counterbore proximate the opening, and a fixing member;

positioning the shaft of the screw through the opening so that the head portion is positioned against the ledge;

moving the fixing member between a first position where the fixing member is not positioned within the channel of the head portion and a second position where at least a portion of the fixing member is positioned within the channel of the head portion;

providing an insertion guide having a proximal end and a distal end;

inserting the distal end of the insertion guide into the counterbore; and

engaging the distal end of the insertion guide with the head portion of the screw.