Lumbar spine fixation apparatus and method

• US 5,306,275 A
• Filed: 12/31/1992
• Issued: 04/26/1994
• Est. Priority Date: 12/31/1992
• Status: Expired due to Term

• Current Assignee: Bryan, Donald W.
• Original Assignee: Bryan, Donald W.
• Inventors: Bryan, Donald W.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US07/999,005
• Time in Patent Office: 481 Days
• Field of Search: 606/53, 606/60, 606/61, 606/65, 606/66, 606/72, 606/73, 606/86, 606/87, 606/103
• US Class Current: 606/914
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7004 with a cross-section which varies along its length A61B17/7019 takes precedence
• CPC Class Codes: A61B 17/7007 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
• 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 17/7044 also having plates, staples or washers bearing on the vertebrae
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/8057 the interlocking form comprising a thread
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence

Abstract

A spinal fixation apparatus and method wherein various elements are mounted to the vertebra and the sacrum of a spine and are selectively interconnected to achieve a predetermined fixation and/or correction of a particular spinal condition. The apparatus includes pedicle screws, bone screws, sacral rods, sublaminar hooks, spinous process hooks, longitudinal rods, lateral rods, universal interlinks, rod clamps, and pedicle screw anchors, all of which can be readily interconnected into a predetermined construct as a spinal fixation apparatus. A burr guide apparatus is provided to prepare the access site for a pedicle screw and a sacral screw guide is used to accurately align the pilot holes for the sacral screws.

Claims

1. A spinal fixation apparatus comprising:

a rod;

a plurality of pedicle screws, each pedicle screw comprising an anchor head with a top at one end and a screw shaft extending from the other end of said anchor head, said screw shaft having a predetermined length sufficient to pass through a pedicle of a vertebra and into threaded engagement with a vertebral body of the vertebra, said anchor head comprising a bolt head external profile and a throughbore passing transversely through an axis of said anchor head, said anchor head having a coaxial, blind bore in said top, said pedicle screw including an anchor body configured to be telescopically received in said blind bore, said anchor body having a transverse hole therethrough, said hole being configured to be placed in registry with said throughbore to allow said rod to be passed through said anchor head, said anchor body including a threaded boss and a nut threadedly engaged to said threaded boss and operable to force said anchor body upwardly relative to said anchor head thereby clamping said rod to said anchor head; and

a first pedicle screw configured to be embedded in a first vertebra and a second pedicle screw configured to be embedded in a second vertebra with said rod clamped by said first pedicle screw and said second pedicle screw, said rod being configured to rigidly orient the first vertebra to the second vertebra.

2. The spinal fixation apparatus defined in claim 1 wherein said rod comprises a sacral rod, said sacral rod comprising a sacral body and a longitudinal rod extending coaxially from one end of said sacral body, said sacral body comprising a diametrically enlarged cylindrical body having at least one transverse throughbore therethrough, said transverse throughbore being formed in a countersink in said cylindrical body and threadedly receiving a bone screw therethrough.

3. The spinal fixation apparatus defined in claim 2 wherein said bone screw comprises a first thread means for threadedly engaging said transverse throughbore and a second thread means for threadedly engaging bone of a sacrum.

4. The spinal fixation apparatus defined in claim 3 wherein said first thread means and said second thread means are identical and comprise a machine thread.

5. The spinal fixation apparatus defined in claim 2 wherein said sacral body comprises two transverse throughbores therethrough, said transverse throughbores each having an axis angularly offset from said axis of said sacral body.

6. The spinal fixation apparatus defined in claim 5 wherein said axis of said transverse throughbores are angularly offset from each other.

7. The spinal fixation apparatus defined in claim 2 wherein said sacral rod comprises a sacral kit for aligning said sacral body with the sacrum, said sacral kit including a sacral screw guide means comprising a sacral screw guide body and a handle extending outwardly from said sacral screw guide body, said sacral screw guide body having an axial throughbore and a coaxial insert, said insert being received in said transverse throughbore while said sacral screw guide body is partially received in said countersink.

8. The spinal fixation apparatus defined in claim 1 comprising an universal interlink means for clamping a first rod to a second rod.

9. The spinal fixation apparatus defined in claim 8 wherein said universal interlink means comprises a first universal interlink comprising a first clamp, a cleat, a threaded anchor bolt, and a nut threadedly engaged to said threaded anchor bolt, said clamp comprising a clamp body having two planar elements with a first hole extending perpendicularly through said planar elements and a second hole extending transversely through said planar elements and offset from said first hole, said planar elements being separated by a slot, said slot extending into said second hole and enabling said planar elements to close said slot incrementally to clamp a first rod in said second hole, said cleat comprising a yoke for said anchor bolt, said anchor bolt having a transverse hole therethrough, said anchor bolt clamping a second rod between said anchor bolt and said cleat, said nut simultaneously clamping said first rod and said second rod with said first universal interlink.

10. The spinal fixation apparatus defined in claim 8 wherein said universal interlink means comprises a second universal interlink comprising a first clamp body and a second clamp body releasably mountable by a bolt to said first clamp body.

11. The spinal fixation apparatus defined in claim 1 wherein said pedicle screw comprises a pedicle screw stabilizer comprising a housing configured to be telescopically placed downwardly over said anchor head and clamped thereto by said nut, said housing comprising a plurality of prongs for piercingly engaging bone in which said pedicle screw is mounted.

12. The spinal fixation apparatus defined in claim 1 comprising at least one spinous process hook for engaging a spinous process of a vertebra and a sublaminar hook means for engaging a sublaminar of the vertebra, said sublaminar hook means comprising a sublaminar hook comprising a rod clamping means and a downwardly depending hook.

13. The spinal fixation apparatus defined in claim 1 wherein said pedicle screw includes a second anchor head having a rod arm extending perpendicularly from said second anchor head, said rod arm being configurated to be clamped by said pedicle screw.

14. The spinal fixation apparatus defined in claim 1 which further comprises a kit to facilitate the insertion of said pedicle screw, said kit comprising a burr and a burr guide for accurately positioning an opening for a pilot hole through the pedicle, said burr comprising a rotatable shaft having a cutting burr on the end thereof and a drill collar behind said cutting burr, said burr guide comprising a hollow tubular element having a pair of opposing cutouts at one end, said cutouts being configured to straddle the transverse process above the pedicle thereby holding said burr guide in position on the pedicle, said drill collar coaxially orienting said burr in said burr guide while said cutting burr is used to cut away cortical bone from the pedicle.

15. A spinal fixation apparatus kit comprising:

a pedicle screw comprising an anchor head and a distal screw extending from said anchor head, said distal screw having a predetermined length, said predetermined length being sufficient to pass through the pedicle of a vertebra into the vertebral body of the vertebra, said anchor head comprising a blind bore coaxial with said screw and a transverse, rod-receiving hole passing through said anchor head and said blind bore on a diameter of said blind bore, an anchor body telescopically received in said blind bore, said anchor body comprising a transverse throughbore in adjustable alignment with said hole in said anchor head, said anchor body including a threaded bolt coaxial with said screw and a nut threadedly mounted to said threaded bolt, said nut being operable to be tightened against said anchor head thereby pulling said throughbore of said anchor body out of alignment with said hole in said anchor head thereby securely clamping a rod to said anchor head, said pedicle screw further comprising a tapered shoulder between said anchor head and said screw, said tapered shoulder outwardly compressing bone of the vertebra thereby reducing micromotion between said anchor head portion of said pedicle screw and the vertebra, said anchor head comprising an external profile of a bolt head;

a universal interlink comprising a pair of clamps, each of said clamps comprising a body with upper and lower faces oriented in parallel and a throughbore through said faces, a side extension having an outwardly opening, transverse slot, said transverse slot terminating inwardly in a transverse throughbore through said side extension, said transverse throughbore telescopically receiving a rod in a slid fit relationship, said clamp being mountable in a face-to-face relationship with a bolt passing through said throughbore, tightening said bolt causing said transverse slots to become more narrow thereby constricting said transverse throughbores while simultaneously interlocking said pair of clamps;

a sacral rod comprising a mounting body having an axis and a fixation rod extending coaxially from one end of said mounting body, said mounting body comprising at least one mounting hole comprising a countersink and a threaded hole in the bottom of said countersink, said mounting hole having an axis that is angularly offset from said mounting body axis;

a sacral screw for securing said sacral rod to a sacrum comprising a screw and a bolt head with a threaded shoulder between said screw and said bolt head, said threaded shoulder threadedly engaging said threaded hole in said mounting body with said bolt head being received in said countersink; and

a rod, said rod having the same diameter as said fixation rod, said rod being conformable and selectively engageable by said universal interlink and pedicle screw, said rod being adaptable to being selectively used as a lateral rod and a longitudinal rod for said spinal fixation apparatus.

16. The spinal fixation apparatus kit defined in claim 15 wherein said pedicle screw comprises a pedicle screw kit for aligning said pedicle screw with the pedicle, said kit comprising a hollow cylindrical burr guide having a notched tip at a first end, said notched tip straddling the transverse process at the pedicle to guide a burr in creating a hole in the cortical bone of the vertebra.

17. The spinal fixation kit apparatus defined in claim 15 wherein said pedicle screw comprises a stabilizer, said stabilizer comprising a hollow housing configured to telescopically engage said anchor, said stabilizer including a plurality of spikes for penetrating the vertebra when said housing is placed downwardly on said pedicle screw.

18. The spinal fixation apparatus kit defined in claim 15 further including a sublaminar hook adjustably mountable to said rod, said sublaminar hook comprising a hook body and a threaded boss extending upwardly from said hook body, a rod clamp, and a threaded nut, said rod clamp having a throughbore therethrough for receiving said threaded boss, said rod clamp engaging said rod when said threaded nut is tightened on said threaded boss, said hook engaging a sublaminar of the vertebrae.

19. The spinal fixation apparatus kit defined in claim 15 wherein said mounting body of said sacral rod comprises a first countersink having a first mounting hole in the bottom of said first countersink and a second countersink having a second mounting hole in the bottom of said second countersink, the axis of said first mounting hole being angularly offset from the axis of said sacral rod and the axis of said second mounting hole being angularly offset from both of said axis of said first mounting hole and said axis of said sacral rod.

20. The spinal fixation apparatus kit defined in claim 19 wherein said sacral rod includes a sacral screw kit having a drill guide means for orienting said sacral screws relative to said axis of said first mounting hole and said axis of said second mounting hole, said drill guide means comprising a cylindrical body having an axial throughbore and terminating at a distal end in a cylindrical guide, the external diameter of said cylindrical body corresponding to the internal diameter of said countersink and the external diameter of said cylindrical guide corresponding to the internal diameter of said mounting hole to thereby guide a drill bit in preparing a hole to receive said sacral screw.

21. A method for providing fixation to a spine comprising the steps of:

obtaining a pedicle screw, said pedicle screw comprising a screw shaft and an anchor head mounted to said screw shaft, said anchor head including a blind bore coaxial with said screw shaft and an anchor body telescopically received in said blind bore, said anchor body including a threaded boss and a nut threadedly engageable to said threaded boss, said anchor head and said anchor body including a throughbore oriented transversely through said anchor head and said anchor body, said throughbore receiving a rod with said nut causing said anchor body to clamp said rod to said anchor head;

mounting at least two of said pedicle screws selectively to vertebrae and the sacrum of the spine;

affixing a rod to the spine by interconnecting said pedicle screws with said rod by passing a portion of said rod into said throughbore; and

clamping said rod to said pedicle screws by tightening said nut on said threaded boss on each of said pedicle screws.

22. The method defined in claim 21 wherein said mounting step includes preparing a sacral rod and affixing said sacral rod to the sacrum of the spine while engaging said sacral rod with said pedicle screw to thereby stabilize the relative position of the vertebra to the sacrum.

23. The method defined in claim 22 wherein said affixing step comprises attaching said sacral rod to the sacrum using at least one bone screw, said bone screw being threadedly engaged to said sacral rod and the sacrum.

24. The method defined in claim 23 wherein said attaching step comprises using at least two bone screws, each bone screw being angularly offset from the axis of said sacral rod and from the axis of the other bone screw.

25. The method defined in claim 21 wherein said clamping step includes obtaining a sublaminar hook and a spinous process hook and engaging a portion of a vertebra between said sublaminar hook and said spinous process hook while affixing the relative positions of said sublaminar hook and said spinous process hook on said rod.

26. The method defined in claim 21 wherein said clamping step includes mounting a plurality of pedicle screws on preselected vertebrae and obtaining universal interlinks and a plurality of rods, said universal interlinks adapting said rods to be secured to said pedicle screws.

27. The method defined in claim 21 wherein said mounting step includes preparing the pedicle of the vertebra by cutting away cortical bone of the transverse process above the pedicle with a burr and guiding said burr with a burr guide thereby assuring accurate cutting of the cortical bone.