METHOD OF ASSEMBLING A PIVOTAL BONE ANCHOR ASSEMBLY WITH SNAP-IN-PLACE BUSHING

Abstract

A method of assembling a pivotal bone anchor assembly includes positioning a bushing into a body member having an axial bore with a lower interior surface adjacent a bottom opening, a channel for receiving a fixation rod, and hollow spaces formed into sidewalls of the axial bore. The bushing includes a curved upper surface for receiving the fixation rod and outwardly protruding structures that resiliently snap into the hollow spaces to inhibit the bushing from moving upward in the axial bore. The method also includes positioning the head of a bone anchor into the axial bore with the bone anchor extending downward through the bottom opening and with the lower interior surface supporting head of the bone anchor to provide for pivotal movement between the bone anchor and the body member prior to locking the pivotal bone anchor assembly via the fixation rod and a closure.

Claims

1. A method of assembling a pivotal bone anchor assembly configured to secure a fixation rod to a bone of a patient with a closure, the method comprising: positioning a bushing into an axial bore of a body member, the body member comprising a base defining a lower portion of the axial bore centered about a vertical centerline axis and communicating with a bottom of the base through a bottom opening, and a pair of upright arms extending upward from the base to define a channel configured to receive the fixation rod, the axial bore extending upwardly from the bottom opening through the channel to tops of the upright arms and including a lower interior surface disposed about the bottom opening, an internal closure mating structure adjacent the tops of the upright arms, and at least one hollow space with a downwardly facing surface formed into sidewalls of the axial bore between the lower interior surface and the tops of the upright arms, the bushing comprising a curved upper surface configured to receive the fixation rod, a central opening, and at least one outwardly protruding structure that resiliently snaps into the at least one hollow space upon positioning of the bushing into the axial bore to inhibit the bushing from moving upward in the axial bore; and positioning a partial spherical head of a bone anchor into the lower portion of the axial bore of the body member, the bone anchor comprising a shank body having a longitudinal axis, the partial spherical head at a proximal end of the shank body, and an anchor portion opposite the partial spherical head configured for attachment to the bone, wherein the lower interior surface of the axial bore supports the partial spherical head of the bone anchor to provide for pivotal movement between the shank body and the body member prior to locking the pivotal bone anchor assembly with the fixation rod via the closure.

2. The method of claim 1, wherein the at least one outward protruding structure of the bushing positioned within the at least one hollow space of the body member inhibits the bushing from rotating relative to the body member about the vertical centerline axis.

3. The method of claim 1, wherein the central opening of the bushing is configured to provide access to the partial spherical head of the bone anchor.

4. The method of claim 1, wherein a lower surface of the bushing engages the partial spherical head of the bone anchor.

5. The method of claim 4, wherein positioning the at least one outward protruding structure of the bushing within the at least one hollow space of the body member establishes a pre-lock press fitment between the lower surface of the bushing and the partial spherical head of the bone anchor so that the bone anchor and the body member do not move freely with respect to each other prior to insertion and securement of the fixation rod with the closure.

6. The method of claim 1, wherein the lower interior surface of the axial bore further comprises an upward facing rounded surface that directly engages the partial spherical head of the shank to form a modified ball joint.

7. The method of claim 1, wherein positioning the partial spherical head of the shank into the lower portion of the axial bore further comprises downloading the shank through the channel of the body member with the anchor portion passing downward through the bottom opening.

8. The method of claim 1, wherein positioning the partial spherical head of the shank into the lower portion of the axial bore further comprises uploading the partial spherical head of the shank through the bottom opening.

9. The method of claim 8, wherein the partial spherical head of the shank and the bottom opening of the body member further comprise complementary threads formed therein, and wherein uploading the partial spherical head of the shank through the bottom opening further comprises threading the partial spherical head of the shank upward through the bottom opening.

10. A method of assembling a pivotal bone anchor assembly configured to secure a fixation rod to a bone of a patient with a closure, the method comprising: positioning a partial spherical head of a shank into a lower portion of an axial bore of a body member, the shank comprising a shank body having a longitudinal axis, the partial spherical head at a proximal end of the shank body, and an anchor portion opposite the partial spherical head configured for attachment to the bone, the body member comprising a base defining the lower portion of the axial bore centered about a vertical centerline axis and communicating with a bottom of the base through a bottom opening, and a pair of upright arms extending upward from the base to define a channel configured to receive the fixation rod, the axial bore extending upwardly from the bottom opening through the channel to tops of the upright arms and including a lower interior surface disposed about the bottom opening, an internal closure mating structure adjacent the tops of the upright arms, and at least one downwardly facing surface formed into sidewalls of the axial bore between the lower interior surface and the tops of the upright arms; and positioning a compression bushing into the axial bore until at least one outer surface of the compression bushing snaps under the at least one downwardly facing surface of the axial bore to inhibit the compression bushing from moving upward in the axial bore, the compression bushing comprising a central opening configured to provide access to the partial spherical head and a curved upper surface configured to receive the fixation rod, wherein the lower interior surface of the axial bore supports of the partial spherical head of the shank within the body member with the shank extending downwardly through the bottom opening.

11. The method of claim 10, wherein the compression bushing cooperates with the body member to exert a distal force towards the head to frictionally hold the head down within the body member prior to a locking of the assembly via the closure, so as to provide a friction fit articulatable relationship between the shank and the body member.

12. The method of claim 10, wherein the lower interior surface of the axial bore further comprises an upward facing rounded surface that directly engages the partial spherical head of the shank to form a modified ball joint.

13. The method of claim 10, wherein positioning the partial spherical head of the shank into the lower portion of the axial bore further comprises downloading the shank through the channel of the body member with the anchor portion passing downward through the bottom opening.

14. The method of claim 10, wherein positioning the partial spherical head of the shank into the lower portion of the axial bore further comprises uploading the head of the shank through the bottom opening.

15. The method of claim 14, wherein the partial spherical head of the shank and the bottom opening of the body member further comprise complementary threads formed therein, and wherein uploading the partial spherical head through the bottom opening further comprises threading the partial spherical head upward through the bottom opening.

16. The method of claim 10, wherein the at least one downwardly facing surface of the axial bore further comprise a pair of opposing downwardly facing surfaces on opposite sides of the axial bore, and wherein the at least one outer surface of the compression bushing further comprises upper surfaces of a pair of opposite engagement structures protruding laterally outward from the bushing.

17. The method of claim 16, wherein the opposing downwardly facing surfaces further comprise the upper surfaces of opposed apertures extending through the sidewalls of the bushing.

18. The method of claim 16, wherein the pair of opposite engagement structures further comprise opposite resilient tabs at the upper ends of the compression bushing.

19. A method of assembling a pivotal bone anchor assembly configured to secure a fixation rod to a bone of a patient with a closure, the method comprising: loading a head of a shank into an axial bore of a body member so the head is located in the axial bore while the shank extends distally through a bottom opening of the body member, the bottom opening extending between the axial bore and a bottom surface of the body member, the head being at least partially spherical and formed on a proximal end of the shank, the axial bore formed along a longitudinal axis of the body member and intersecting a channel of the body member adapted to receive the fixation rod, the axial bore including a proximal closure mating structure adapted to receive the closure, an inwardly protruding structure between the proximal closure mating structure and the bottom opening, and a distal interior surface adjacent the bottom opening supporting the head while allowing for pivotal movement of the shank relative to the body member; and loading a compression bushing into the axial bore so the compression bushing is pressed at least partially past the inwardly protruding structure with an interference surface engagement between the compression bushing and the inwardly protruding structure to inhibit the head and the compression bushing from moving upward within the axial bore.

20. The method of claim 19, wherein the compression bushing cooperates with the body member to exert a distal force towards the head to frictionally hold the head down within the body member prior to a locking of the assembly via the closure, so as to provide a friction fit articulatable relationship between the shank and the body member.

21. The method of claim 19, wherein the distal interior surface of the axial bore further comprises an upward facing rounded surface that directly engages the head of the shank to form a modified ball joint.

22. The method of claim 19, wherein loading the head of the shank into the axial bore of the body member further comprises downloading the shank through the channel of the body member with an anchor portion of the shank passing downward through the bottom opening.

23. The method of claim 19, wherein loading the head of the shank into the axial bore of the body member further comprises uploading the head of the shank through the bottom opening.

24. The method of claim 23, wherein the head of the shank and the bottom opening of the body member further comprise complementary threads formed therein, and wherein uploading the head of the shank through the bottom opening further comprises threading the head of the shank upward through the bottom opening.

25. A method of assembling a pivotal bone anchor assembly configured to secure a fixation rod to a bone of a patient with a closure, the method comprising: loading a head of a shank into an axial bore of a body member so the head is located in the axial bore while the shank extends distally through a bottom opening of the body member, the bottom opening extending between the axial bore and a bottom surface of the body member, the head being at least partially spherical and formed on a proximal end of the shank, the axial bore formed along a longitudinal axis of the body member and intersecting a channel of the body member adapted to receive the fixation rod, the axial bore including a proximal closure mating structure adapted to receive the closure, a distal interior surface adjacent the bottom opening supporting the head while allowing for pivotal movement of the shank relative to the body member, and opposing hollow spaces with downwardly facing surfaces formed into sidewalls of the axial bore between the proximal closure mating structure and the bottom opening; and loading a compression bushing into the axial bore until opposite engagement structures projecting outward from first and second arms of the compression bushing are respectively received in the opposed hollow spaces to inhibit the head and the compression bushing from moving upward within the axial bore, the first and second arms defining a curved upper surface therebetween adapted to receive the fixation rod.

26. The method of claim 25, wherein the opposite engagement structures resiliently snap into the opposed hollow spaces during the loading of the compression bushing into the axial bore.

27. The method of claim 25, wherein upper surfaces of the opposite engagement structures resiliently engage the downwardly facing surfaces of the hollow spaces to establish a pre-lock press fitment between a lower surface of the compression bushing and the head of the shank so that the shank and the body member do not move freely with respect to each other prior to insertion and securement of the fixation rod with the closure.

28. The method of claim 25, wherein the lower interior surface of the axial bore further comprises an upward facing rounded surface that directly engages the head of the shank to form a modified ball joint.

29. The method of claim 25, wherein loading the head of the shank into the axial bore of the body member further comprises downloading the shank through the channel of the body member with an anchor portion of the shank passing downward through the bottom opening.

30. The method of claim 25, wherein the head of the shank and the bottom opening of the body member further comprise complementary threads formed therein, and wherein loading the head of the shank into the axial bore of the body member further comprises threading the head of the shank upward through the bottom opening.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a perspective view of the variable angle spinal screw assembly of the present invention.

[0016] FIG. 2 is a perspective view of the bone screw portion of the assembly of the present invention.

[0017] FIGS. 3A and 3B are perspective views of the body member of the assembly of the present invention.

[0018] FIG. 4 is another perspective view of the body member of the present invention showing the lower surface thereof.

[0019] FIG. 5 is a perspective view of the bushing employed in the present invention.

[0020] FIGS. 6A and 6B are perspective views of a first embodiment of the cap of the present invention.

[0021] FIG. 7 is a second embodiment of the cap of the present invention.

[0022] FIG. 8 is a side view of the variable angle spinal screw assembly of the present invention.

[0023] FIG. 9A is a sectional view taken along the line A-A of FIG. 8

[0024] FIG. 9B is a sectional view taken along the line B-B of FIG. 8.

[0025] FIG. 10 is an exploded view of a modified form of the pedicle screw and body member employed in the present invention.

[0026] FIG. 11 is a perspective view of the modified pedicle screw and body member of FIG. 10 shown in the attached position prior to threading the body member over the screw head to form the mating relationship between the spherical lower portion of the screw head and the interior lower surface of the body member.

[0027] FIG. 12 is an exploded perspective view of another modified form of the pedicle screw and body member employed in the present invention.

[0028] FIG. 13 is a representational side view of the embodiment of the pedicle screw and body member shown in FIG. 12 with the body member on the screw in the mating variable angle position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0029] Referring now in detail to the drawings, the variable angle spinal screw assembly 10 of the present invention comprises a pedicle screw 12, a body member 14, a bushing 16 and a locking cap 18. The assembly 10 is used with at least one other such assembly and a stabilization or fixation rod 19 to connect the assemblies and stabilize the vertebras into which the assemblies are inserted. The pedicle screw 12 preferably employed in assembly 10 has a spherical head 20 defining a slot 22 therein used to drive the screw into the bone. The rounded surface 24 defined by the lower portion of screw head 20 rests upon and mates with a rounded interior surface 26 formed in the inner or lower end of the body member 14 of the assembly 10 so as to form a modified ball joint that provides the desired variable angular movement of the body member with respect to the embedded pedicle screw. The threaded shaft portion 28 of screw 12 extends therefrom through the opening 30 in the lower end of body member 14.

[0030] The body member 14 of assembly 10 further defines a pair of opposed parallel slots 32 axially disposed in the side wall 34 thereof, which terminate at their lower ends in curvilinear surfaces 36. The two slots 32 are sized to receive the fixation rod therein as shown in the drawings with the walls 35 defining the slots preferably extending upwardly beyond the midpoint of the rod and can be inclined slightly to provide a slight holding force on the rod prior to securing the rod with the locking cap 18. Thus, during assembly, the surgeon exerts a slight downward force on the rod, snapping the rod into the transverse channel defined by the aligned slots 32.

[0031] The outer or upper interior surface of side walls 34 of the body member 14 both have radially projecting serrations formed therein defining a plurality of axially aligned ratchet teeth 38. The exterior bottom surface 40 of body member 14 has spaced outwardly extending concave surface 42 formed therein and a pair of perpendicularly disposed concave surfaces 44. Surfaces 42 and 44, together with mating surfaces 24 and 26 on the screw head and body member of the assembly, provide an extended range of motion of the body member 14 with respect to the pedicle screw 12. In one embodiment, the range of motion is about +/−30 degrees in all directions (as measured from the longitudinal axis of the screw) and about +/−40 degrees in the inferior-superior direction, the outwardly (as viewed from the screw head) concave surfaces provide the +/−40 degree range of motion, for a total motion range of 80 degrees. This extended range of motion, as compared to the prior art, allows the surgeon additional freedom in locating the screws and eases the assembly process by reducing the requirement for a rod contouring.

[0032] To secure the fixation rod 19 within the body member 14 of the assembly, locking cap 18 is provided. Cap 18 defines a top portion 48, a pair of opposed arcuate depending leg portions 50 and a centrally disposed depending projection 52 equidistantly spaced from leg portions 50. Central projection 52 preferably defines a planar lower or bottom surface 54. The leg portions 50 of cap 18 each have a plurality of radially projecting serrations formed therein that define a plurality of axially aligned ratchet teeth 56 adopted to engage teeth 38 on the opposed interior side walls 34 of the body member 14, as will be described

[0033] A bushing 16 is preferably employed within the body member 14 of the assembly 10 adjacent side walls 34 to better distribute the longitudinal forces exerted on the pedicle screw. Bushing 16 defines a pair of opposed concave surfaces 60 formed in the upper end of a circular skirt 62 so as to define a seat 64 for the fixation rod 19. The lower portion of bushing skirt 62 is slotted at 66 to provide flexibility therein and defines depending tapered end surfaces 68 adapted to abut opposed sides of the rounded screw head 20. A pair of outwardly projecting opposed resilient tabs 70 are provided at the upper ends of the bushing 16 between concave surfaces 60 that in some embodiments are adapted to be received in a snap fitment within a pair of opposed apertures (not shown) formed in the side wall 34 of body member 14 whereupon the rod seat 64 in bushing 16 is aligned with the channel in the body member. Note that in the illustrated embodiment shown in FIG. 3B, for example, the resilient tabs 70 will engage with the body member 14 inner cylindrical surface located below the ratchet teeth 38, the illustrated aperture 72 being located in the vicinity of the ratchet teeth 38 that cooperate with the locking cap 18 and thus at a distance from the bushing 16. Note that only one of apertures 72 is illustrated in FIGS. 3A and 3B to better illustrate the configuration of the ratchet teeth 38. In an alternative embodiment, the tabs could be removed from the bushing 16 and located on the body member 14 for engagement with apertures or other receiving structure or members formed in opposed sides of the bushing.

[0034] To provide a basic stability to the system during initial assembly, the bushing 16 with its slotted lower skirt portion can be configured to provide a press fitment about the screw head 20 so that the pedicle screw 12, body member 14 and bushing 16 will not move freely prior to the insertion and securement of the fixation rod. In addition, the upper portion of the bushing could be configured such that the wall surfaces 60 defining the rod seat 64 therein extend upwardly past the midpoint of the rod and are slightly inwardly inclined. This would provide the same slight holding force when the rod is pushed into the bushing seat 64 that was above described with reference to the channel walls 35 in the body member 14 of the assembly 10.

[0035] Upon securing the bushing 16 in the body member 14 and the fixation rod 12 in bushing seat 64, the locking cap 18 is positioned such that the depending leg portions 50 thereon are aligned with the side walls 34 of body member 14. Upon pressing the cap 18 downwardly into body member 14, the ratchet teeth 38 and 56 on the assembly body and cap interlock so as to allow the cap to be pressed downwardly but not retracted. As cap 18 is pressed downwardly into the body member of the assembly, the planar bottom surface 54 of the central projection 52 thereon abuts the fixation rod 19 and presses the rod into and against the seat 64 formed on the upper end of bushing 16. The resulting pressure on the bushing causes the tapered surfaces 68 on the lower end of the bushing to press against the rounded surface of the screw head 20, thereby securing the rod in seat 64 and providing a decentralized and evenly distributed force acting along the longitudinal axis of the screw. Thus, the use of bushing 16 creates a taper lock between the pedicle screw and body member and increases the area of contact therebetween. The result is an improved locking securement over that provided by the earlier described direct contact of the fixation rod against the upper end of the screw head.

[0036] The interlocked ratchet teeth will allow the surgeon to tighten the clamping force on the fixation rod by simply pressing downwardly on the locking cap 18. The teeth will hold the component parts in place. To adjust or remove the rod 19, the locking cap 18 is simply rotated 90 degrees about its longitudinal axis, whereupon the teeth 38 on the depending leg portions 50 of the cap are aligned with the open slots 32 in the body member 14, allowing the cap to be simply pulled upwardly away from the fixation rod 19. A hexagonally configured slot 71 is provided in the top portion 48 of cap 18 to facilitate the rotation of the locking cap with a suitably sized mating tool.

[0037] In use, at least two of the pedicle screws 12 with the body members 14 and attached bushings 16 disposed about the screw are inserted into the vertebra pedicles spanning the vertebra to be fixated. The surgeon preliminary contours the fixation rod and checks the alignment between the rod and the mating channels formed by the slots in the bushing and body member of the assemblies. Since additional contouring is usually required to improve the alignment, the surgeon incrementally adjusts the rod shape and checks the fit within the channels until the rod properly fits in all channels. During the contouring process, a locking cap 18 can be mated with one or more of the body member 14 (by pressing the cap axially into the body member to create the interlock between the ratchet teeth on the body member and the cap) to temporarily hold the rod in place, thereby assisting the surgeon in achieving an accurate fit. The locking caps are then easily removable (by rotating the cap a quarter of a turn to disengage the interlocking teeth), allowing the rod to be further contoured. Once properly contoured, the rod is inserted into the channels and a locking cap is pressed tightly into each body member and bushing to secure the rod in place. To effect securement of the rod at each of the pedicle screw assemblies, it is solely necessary to press the locking cap longitudinally into the body member such that the bottom surface 54 of the central projection 52 on the cap presses against the fixation rod 19, causing the rod to press downwardly against the bushing 16, which in turn mates with and presses against the head of the pedicle screw.

[0038] A modified form of the variable angle spinal screw assembly is illustrated in FIGS. 10 and 11. This modified form of the assembly enables the surgeon to insert the pedicle screw in the bone, by itself, unencumbered by the body member. In the prior embodiment, the pedicle screw 12 must be inserted through the body member 14 before the screw can be driven into the bone. With the body member attached, securement of the screw into the bone can be somewhat difficult. In the modified assembly 100, the outer surface of the spherical head portion 120 of the pedicle screw 112 is provided with threads 121, as seen in FIG. 10. As in the prior embodiment, the upper end of head portion 120 is provided with a vertical slot 122 used to drive the screw into place. The lower interior portion 113 of the body member 114 to be used with the modified pedicle screw 112 is provided with threads 115 adapted to engage threads 121 on the screw. As a result, the body member 114 can be threaded onto (see FIG. 11) and over the head 120 of the screw 112 after the screw is driven into place. With the exception of threads 121 and 115, the pedicle screw 112 and body member 114 are identical in configuration to the screw 12 and body member 14 of the prior embodiment. Thus, after the body member 114 is threaded onto and over the screw head and is disposed within the interior of the lower end of body member 114, as seen in FIG. 11, the variable angular relationship therebetween is formed as in the prior embodiment.

[0039] A second modified form of the variable angle spinal screw assembly that enables the surgeon to insert the pedicle screw in the bone, by itself, unencumbered by the body member is illustrated in FIGS. 12 and 13. As seen therein, the mating threads on the pedicle screw 112 and body member 114 have been replaced with mating octagonal surfaces. In this second modified assembly 200, the outer surface of the spherical head portion 220 of the screw 212 is provided with an octagonal portion. The octagonal portion is comprised of eight contact surfaces 221, one of which (e.g. 221a) is unequal in length to the remaining surfaces. The lower interior portion 213 of the body member 214 to be used with the modified pedicle screw 212 is also provided with an octagonally configured portion adapted to engage and mate with the octagonal surfaces on the screw head. Because of the inclusion of a differently-sized surface on both the screw and body member, the pedicle screw 212 will only align with the body member 214 in only one position, i.e., where the shortened contact surface on the screw head is aligned with the correspondingly shortened surface in the lower interior of the body member. Accordingly, the pedicle screw 212 can again be inserted into the bone without being attached to the body member 214. After the screw 212 is driven into place, the body member 214 can be inserted over the screw head with the octagonal surfaces thereon aligned with the corresponding surfaces on the screw head. By pressing the screw body downwardly, it is completely inserted onto the screw head and the mating octagonal surfaces are moved out of engagement. Upon rotating the body member and pulling upwardly on the body member, such that the head is disposed within the interior of the lower end of body member 214 the variable angular relationship therebetween illustrated in FIG. 13 is formed as in the prior embodiments. It is to be understood that this form of the present invention is not limited to the use of mating octagonal surfaces. Any polygonal configuration could be employed on the screw head and body member wherein at least one of the mating surfaces on the screw head and on the body member is correspondingly off-sized or otherwise differently configured from the remaining surfaces on the screw head and body member.

[0040] In another embodiment of the invention, the bushing 16 is not employed. The opposed axial slots 32 in the side wall 34 of the body member of the assembly define a seat for the fixation rod 19. When the locking cap is pressed into the body member with the fixation rod extending thereacross, the planar bottom surface 54 of the central projection 52 again abuts the fixation rod and, in this instance, presses the rod against the upper end of the head of the pedicle screw. For such applications, the body member and pedicle screw would be sized such that the upper surface of the screw would project above the bottom of the seat defined by the axially opposed slots 32 so as to enable the rod to press against the screw and create a rigid, yet adjustable, securement between the body member and the pedicle screw. This embodiment can also be utilized with the modified forms of the pedicle screw 128 and body member 114 shown in FIGS. 10 and 11. In all of these embodiments, the components of the variable angle spinal screw assembly are preferably formed of titanium.

[0041] It should be noted that while the preferred configuration of the locking cap provides a rounded and flush mounting on the upper ends of the body member 14 when the locking cap is fully inserted against the fixation rod, other locking cap configurations could be employed. For example, FIG. 7 illustrates a locking cap having a generally cylindrical perimeter portion in which the ratchet teeth 56 project radially therefrom along leg portions 50. This configuration is illustrated in FIG. 1. As a result, the upper end of the locking cap would be inwardly offset from the upper end of the body member without adversely affecting the operation of the variable angle spinal screw assembly. Various other changes and modifications also could be made in carrying out the present invention.

[0042] Although the present invention has been described by way of exemplary embodiments, it should be understood that many changes and substitutions may be made by those skilled in the art without departing from the spirit and the scope of the present invention, which is defined by the appended claims.