WO2003099148A2

WO2003099148A2 - Vertebrae bone anchor and cable for coupling it to a rod

Info

Publication number: WO2003099148A2
Application number: PCT/US2003/015781
Authority: WO
Inventors: James W. Ogilvie; Matthew M. Morrison; Michael S. Veldman; Harold Sparr Taylor
Original assignee: Sdgi Holdings, Inc.
Priority date: 2002-05-21
Filing date: 2003-05-20
Publication date: 2003-12-04
Also published as: EP1509148B1; CA2486536A1; US20040111091A1; AU2003233587A1; AU2003233587B2; JP4350647B2; US7338490B2; JP2005525908A; WO2003099148A3; EP1509148A2

Abstract

Methods and apparatus for alignment of vertebrae. In one embodiment, the invention includes a hook-shaped member (30) which receives a bone anchor (26), both the member and the anchor being fixed to a portion of bone. The assembly of hook and anchor are coupled to a surgical rod (22) by a cable (50) and connector.

Description

REDUCTION CABLEANDBONEANCHOR

This application claims the benefit of priority to U.S. provisional patent application Serial No. 60/382,332, filed May 21, 2002 and U.S. provisional patent application Serial No. 60/382,320, filed May 22, 2002, both of are incorporated herein by reference.

FIELD OF THE INVENTION The present invention pertains to methods and apparatus for alignment of vertebrae.

BACKGROUND OF THE INVENTION

In some alignment surgeries, stainless steel wires are passed under the lamina, through the spinal canal, and tightened around spinal rods in a segmental manner. The wires are attached to rods progressively and segmentally in a method which reduces the distance between the curved spine and the contoured spinal rod.

Although this method is mostly effective, the passage of wires into the spinal canal has been reported as a source of clinical complications, both intra-operatively and post-operatively. What is needed are methods and apparatus which permit attachment of vertebrae to a spinal rod without passing wires into the spinal canal. The present invention provides these methods and apparatus in novel and unobvious ways.

SUMMARY OF THE INVENTION One embodiment of the present invention concerns an apparatus for alignment of vertebrae. The embodiment comprises a surgical rod and a hook-shaped member adapted and configured for receiving a portion of bone within the hook. The embodiment further includes an anchor having a body adapted and configured for fixation into a bone and a head, the anchor coupling to the member. The embodiment further includes a cable coupling said hook-shaped member to the rod.

Another embodiment of the present invention concerns an apparatus for alignment of vertebrae. The embodiment comprises a surgical rod and a hook-shaped member adapted and configured for receiving a portion of bone within the hook. The embodiment further includes a cable coupling the hook-shaped member to the rod and having first and second ends. The embodiment further includes a connecting member which receives therein the first end and the second end, each first and second ends being adapted and configured for pivotal coupling to the connecting member.

Yet another embodiment of the present invention concerns an apparatus for alignment of vertebrae. The embodiment comprises a surgical rod having a first cross- sectional shape. The embodiment further includes an anchor adapted and configured for fixation into a bone. The embodiment further includes a cable coupling the anchor to the rod and having first and second ends, and further includes a connecting member having a first extended portion connected to the first end of the cable and a second extended portion connected to the second end of the cable, and having a middle section between the first and second extended portions, the middle section having a second cross-sectional shape generally complementary to the cross-sectional shape of the rod.

A further embodiment of the present invention concerns an apparatus for alignment of vertebrae. The embodiment comprises a surgical rod and a hook-shaped member including first and second arms, one of the arms defining an open slot. The embodiment includes a bone anchor coupling the hook-shaped member to a bone. The embodiment includes a cable coupling the hook-shaped member to the rod, a portion of the cable being received within the open slot. The embodiment further includes a connecting member having a first extended portion connected to the cable and a second extended portion connected to the cable.

These and other objects of the present invention will be shown in the description of the preferred embodiment, the drawings and the claims to follow.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a cable and bone anchor assembly according to one embodiment of the present invention.

FIG. 2 is an elevational view of the assembly of FIG. 1.

FIG. 3 is a side view of the bone screw of FIG. 1.

FIG. 4 is view of the apparatus of FIG. 3 as taken along line 4 - 4 of FIG. 3.

FIG. 5 is an elevational side view of a portion of the assembly of FIG. 1. FIG. 6 is an end elevational view of the hook of the assembly of FIG. 1. FIG. 7 is a top view of the apparatus of FIG. 6 as taken along line 7 - 7 of FIG. 6.

FIG. 8 is side elevational view of the apparatus of FIG. 7 as taken along line 8 - 8 of FIG. 7.

FIG. 9 is a side elevational view of the apparatus of FIG. 6 as taken along line 9 - 9 of FIG. 6.

FIG. 10 is a cutaway view of the apparatus of FIG. 6 as taken along line 10 - 10 of FIG. 6.

FIG. 11 is a perspective view of the apparatus of FIG. 1 as attached to a vertebrae.

FIG. 12 is a perspective view of the apparatus of FIG. 1 as attached to a vertebrae. FIG. 13 is a perspective view of the apparatus of FIG. 1 as attached to a vertebrae.

FIG. 14 is a perspective view of the apparatus of FIG. 1 as attached to a vertebrae.

FIG. 15 is an end elevational view of an apparatus according an alternate embodiment of the present invention.

FIG. 16 is a view of the apparatus of FIG. 15 as taken along line 16-16 of FIG. 15. FIG. 17 is a cross sectional view of the apparatus of FIG. 15 as taken along line 17-

17 of FIG. 15.

FIG. 18 is a view of the apparatus of FIG. 15 as taken along line 18-18 of FIG. 15.

FIG. 19A is a view of the apparatus of FIG. 18 as taken along line 19A-19A of FIG. 18. FIG. 19B is a view of a hook-shaped member according to another embodiment of the present invention, as viewed similarly to FIG. 19A.

FIG. 19C is a view of a hook-shaped member according to another embodiment of the present invention, as viewed similarly to FIG. 19A.

FIG. 20 is a view of the apparatus of FIG. 18 as taken along line 20-20 of FIG. 18. FIG. 21 is a view of the apparatus of FIG. 18 as taken along line 21 -21 of FIG. 18.

FIG. 22 is a cross sectional view of the apparatus of FIG. 18 as taken along line 22- 22 of FIG. 18.

FIG. 23 is a side elevational view according to another embodiment of the present invention. FIG. 24 is a side elevational view of an apparatus according to another embodiment of the present invention. FIG. 25 is a perspective view of a cable and hook member assembly according to another embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.

The present invention relates to various apparatus and methods for alignment of vertebrae. In one embodiment, the invention includes a bone screw anchor including a swivel mechanism and a hook to provide a distributed load surface during reduction maneuvers. In some embodiments the hook is coupled to the vertebrae by a bone screw or a staple. In yet other embodiments the hook is maintained in a load-bearing orientation relative to the vertebrae by the relative placement of the hook, rod, and attaching cable. In these other embodiments, the bone screw, staple, or other fastening feature is optional. In yet other embodiments of the present invention, the hook is optional. In these embodiments, the bone screw, staple, or other fastener includes a passageway to accept the flexible cable placed therethrough. The cable directly connects the fastener to the connector without the need for the hook.

Referring to FIGS. 1 and 2, an apparatus 20 is shown according to one embodiment of the present invention. A surgical rod 22 (shown in section) follows a path chosen by a surgeon and substantially parallel to the spine. Apparatus 20 includes a bone screw 26 which is anchored into a vertebrae (not shown). Screw 26 is rotatably coupled at one end to a hook-shaped member 30 which is adapted and configured for receiving a portion of bone within the hook. A section of flexible cable 50 passes around one arm of member 30 and couples member 30 to rod 22. The ends of cable 50 are coupled to a connector 60 which preferably straddles a portion of rod 22. With appropriate tightening of cable 50, member 30 and bone screw 26 apply a load into the vertebrae sufficient to position the vertebrae proximate to rod 22.

The extent to which cable 50 is tightened depends upon decisions by the surgeon. For example, in some embodiments of the present invention, there is a gap between rod 22 and hook 30, in contrast to the rod to hook contact depicted in FIG. 1. In these alternate embodiments, the surgeon can opt to provide limited tightening of cable 50 around rod 22. This limited tightening can take into account, for example, a decision on the part of the surgeon to move the selected vertebrae by a limited amount. Thus, the present invention contemplates embodiments in which cable 50 is tightened sufficiently to bring rod 22 snugly against a surface of hook 30 (which, in some embodiments of the present invention, causes the rod to cover at least a portion of the head), and also those embodiments in which a gap is maintained between rod 22 and surfaces of hook 30.

FIGS. 3 and 4 show side and end views, respectively, of bone screw 26. Screw 26 preferably includes self-tapping features and also features that resist undesirable loosening after implantation. Screw 26 includes a threaded shank 27 and a head 28. Head 28 preferably includes a semi-spherical surface 28.1 which rotatably couples screw 26 to one arm of member 30, as will be described later. Head 28 preferably includes a hex-shaped slot 29 for torquing of screw 26.

FIGS. 6 - 10 show various views of a hook-shaped member 30 according to one embodiment of the present invention. Member 30 includes a pair of opposing arms 32 and 34 which are joined at one end and spaced apart at the other end such that member 30 preferably has a "U" or "V shaped side appearance. Arms 32 and 34 define a groove or pocket 33 therebetween for receiving a portion of bone. In some embodiments, arms 32 and 34 are of different lengths. Referring to FIG. 8, as one example the distance from the topmost outer radius at the joined end of the arms to the bottommost tip of arm 34 is about 14-15 millimeters, whereas the distance from the same outer radius to the bottommost tip of arm 32 is 16 to 17 millimeters. Referring to FIG. 10, in one embodiment the inner, bone-contacting surfaces of arms 32 and 34 are preferably flat and define an included angle 36 of about 20 to 25 degrees. However, the present invention also contemplates those embodiments in which arms 32 and 34 are generally parallel, and also those embodiments in which the included angle is greater than 25 degrees. Preferably, member 30 is fabricated from an alloy such as Ti-6AL-4V according to ASTM F-136. Although reference to specific dimensions and materials are given, the present invention is not limited to such specific details. As best seen in FIGS. 7 and 10, arm 32 includes an aperture or through-hole 38 which is sized to accept the shank 27 of screw 26. Arm 32 also includes a radiused pocket 39 which is adapted and configured to permit three-dimensional rotation of surface 28.1 of screw head

28. Referring now to FIGS. 6 and 10, opposing arm 34 includes at its free end a slot 40 located between a pair of extensions 41a and 41b. Extensions 41a and 41b are preferably spaced apart to accept the outer diameter of shank 27, as best seen in FIGS 1 and 2. However, the present invention also contemplates those embodiments in which the shank of the bone screw passes through an aperture or clearance hole 140 defined by arm 134 of hook

130 (see FIG. 19B). Further, the present invention also contemplates those embodiments in which the arm of a hook 230 includes an aperture or slot 240 to receive the screw shank, except that the slot open end is rotated 90 degrees, such that the open end breaks laterally through a side of arm 34 (an orientation similar to notches 42a and 42b which laterally break through side surfaces of arm 32; see FIG. 19C).

Referring to FIGS. 7, 8, and 9, arm 32 includes a pair of laterally opposing notches 42a and 42b which are sized to accept therein cable 50. A radiused notch 43 extends between notches 42a and 42b. Preferably, notch 43 provides a relief space for cable 50, such that cable 50 does not protrude into the "U" or "V shaped pocket area 33 and does not contact any bone located therein.

Referring now to FIG. 5, a connector 60 provides means for coupling hook member 30 to rod 22. Connector 60 includes a pair of extended portions or opposing ends 60a and 60b which are interconnected by a middle section or rod-coupling portion 66. Portion 66 preferably has a shape that is complementary to the exterior shape of rod 22. In some embodiments of the present invention, the rod has a circular cross sectional shape and middle section 66 includes a complementary semi-circular shape. As best seen in FIG. 2, rod coupling portion 66 has a width or circumferential extent that is about the same as the diameter of rod 22. Rod coupling portion 66 spaces apart opposing ends 60a and 60b such that in some embodiments, the cable does not contact the rod after the cable is tightened. However, the present invention also contemplates those embodiments in which connector 60 is of a geometry such that the cable contacts portions of rod 22. Each end 60a and 60b preferably includes an internal smooth pocket 62 and 64, respectively. Pockets 62 and 64 rotatably receive fittings 52 and 54, respectively, and permit rotation of the fittings. Fittings 52 and 54 are attached to ends 50a and 50b, respectively, of cable 50. In one embodiment, fitting 54 is a spherical or cable ball end firmly attached to cable end 50b, and fitting 52 is a crimpable cable fitting which is crimped tightly onto cable 50 prior to tightening and cutting cable 50 to the proper length.

FIGS. 11-14 depict various views of an apparatus 20 coupled to a vertebrae. After cutting or otherwise manipulating the vertebrae as required, the surgeon places hook-member 30 proximate to the vertebrae. Member 30 can be held by a forceps with male ends that fit within recesses 44a and 44b. Member 30 is prevented from backing away from the vertebrae by placement of a staple or insertion of screw 26, as shown in FIG. 1. A connector 60 is placed on one side of a spinal rod 22. A length of cable including a fitting 54 is threaded through pocket 64 of connector and threaded around arm 32 of member 30, with the cable being running through 42a, 42b, and 43. The free end of cable 50 is threaded through pocket 62 at the other end of connector 60. A crimpable fitting 52 is placed over the free end of the cable, and moved into proximity with pocket 62. The cable is tightened such that the exterior of rod 22 rests within recess 66, with connector ends 60a and 60b straddling rod 22. After the appropriate tension has been applied, fitting 52 is crimped tightly onto cable 50, and the excess length of cable 50 is removed. In some embodiments of the present invention, a spinal implant rod has attached to it a plurality of connectors, each connector being coupled by a flexible cable to a plurality of hook-shaped members. In some embodiments, all flexible cables are tightened in order to bring each hook-shaped member into contact with the rod. In yet other embodiments, the flexible cables are tightened such that none of the hook-shaped members are in contact with the rod. It is appreciated that in yet other embodiments, some of the cables are tightened to place one or more of the hooks in contact with the rod, and other cables are tightened such that one or more of the hooks are spaced apart from the rod.

FIGS. 15-25 depict hook-shaped members according to various alternate embodiments of the present invention. The use of a prime (') designation refers to an element that is the same as the non-prime element, except for those differences shown or described. The use of an "N" prefix (NXX) refers to an element that is the same as the non- prefixed element (XX), except for those differences shown or described.

As best seen in FIGS. 15, 16, and 20, hook-shaped member 30' includes reduced- width portions 42a' and 42b' along laterally opposing sides of arm 34'. As seen best in FIG. 16, these reduced-width portions 42a' and 42b' blend into larger-width portions both at the juncture of arms 34' and 32', and also in the vicinity of aperture 38'. These reduced-width portions coact with slot 43 ' both to accurately locate the cable, and also to minimize sharp bends in the cable.

FIG. 23 is a side elevational view according to another embodiment of the present invention. Apparatus 320 is the same as apparatus 20, except for the changes shown and described. Apparatus 320 eliminates the hook-shaped member from the assembly. Instead, anchor 328 defines an aperture or through hole 328.2 that passes through the anchor. Cable 350 and connector 360 coact to couple rod 322 to anchor 328. In some embodiments, head 329 may include a cylindrical recess to accept the exterior shape of rod 322. FIG. 24 is a side elevational view of a hook-shaped member 430 according to another embodiment of the present invention. Member 430 includes a slot 443 that is open on either end and enclosed therebetween. Cable 450 (not shown) passes through slot 443.

FIG. 25 is a perspective view of an assembly 520 according to another embodiment of the present invention. Alignment apparatus 520 is the same as apparatus 20, except that the bone anchor is omitted. In some embodiments, hook-shaped member 530 may include any of the barbs, prongs, tines, or pointed tips as disclosed in U.S. Patent No. 6,299,613, issued October 9, 2001 to Ogilvie et al. These barbs, prongs, tines, and/or pointed tips (not shown) may be included on one or more of the inner surface 534.1 of arm 534, the inner surface 532.1 of arm 532, the end surfaces 541.1a and 541.1b of extensions 541a and 541b, respectively; and/or the inner wall 540.1 of aperture 540.

This application incorporates by reference U.S. Patent No. 5,569,253 to Farris and Bonner, issued October 29, 1996; and also U.S. Patent No. 5,782,831 to Sherman and Drewry, issued July 21, 1998, and also U.S. Patent No. 6,299,631 to Ogilvie et al, issued October 9, 2001. While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

WHAT IS CLAIMED IS:

1. An apparatus for alignment of vertebrae, comprising: a surgical rod; a hook-shaped member adapted and configured for receiving a portion of bone within the hook, said member defining an aperture therethrough; an anchor having a body adapted and configured for fixation into a bone and a head, said body passing through the aperture when fixed to the bone; and a cable coupling said hook-shaped member to said rod.

2. The apparatus of claim 1 wherein said aperture is a first aperture, said hook-shaped member includes first and second arms connected at one end and spaced apart at the other end to form a pocket therebetween for receiving the portion of bone, one of said arms defining said first aperture, the other of said arms defining a second aperture, said body passing through the second aperture when fixed to the bone.

3. The apparatus of claim 2 wherein said first aperture is a hole, and said second aperture is a slot.

4. The apparatus of claim 1 wherein said cable has first and second ends and said rod has a curved cross-section, and which further comprises a connecting member defining a first pocket for receiving therein the first end and a second pocket for receiving therein the second end and a middle section between the first pocket and the second pocket, said middle section having a curvature generally complementary to the curved cross-section of said rod.

5. The apparatus of claim 4 wherein each said first and second ends of said cable include a spherical portion, and each said first and second pockets include a spherical recess adapted and configured for receiving therein the corresponding spherical end portion.

6. The apparatus of claim 1 wherein said anchor is a bone screw.

7. The apparatus of claim 1 wherein said hook-shaped member defines a notch adapted and configured to receive therein said cable.

8. An apparatus for alignment of vertebrae, comprising: a surgical rod; a hook-shaped member adapted and configured for receiving a portion of bone within the hook; a cable coupling said hook-shaped member to said rod and having first and second ends, one of said first and second ends of said cable including a spherical portion; and a connecting member defining a first pocket for receiving therein the one end, said first pocket including a spherical recess adapted and configured for receiving therein the spherical end portion of the one end.

1-5

9. The apparatus of claim 8 wherein both said ends of said cable include a spherical portion, said connecting member defines a second pocket for receiving therein the other end, said second pocket including a spherical recess adapted and configured for receiving therein the corresponding spherical end portion of the 0 other end.

10. The apparatus of claim 8 which further comprises an anchor adapted and configured for fixation into a bone, said anchor coupling said hook-shaped member to a bone.

5 11. The apparatus of claim 10 wherein said anchor includes a head, said hook- shaped member defines a pocket for receiving the head, and said rod covers at least a portion of head when said cable is tightened.

12. The apparatus of claim 8 wherein said hook-shaped member defines an 0 open slot and a portion of said cable wraps around said hook-shaped member and is received within the open slot.

13. The apparatus of claim 8 wherein said surgical rod has a circular cross- sectional shape, and said connecting member includes a middle section between the first pocket and the second pocket, said middle section having a circular cross-

5 sectional shape generally complementary to the circular cross-sectional shape of said rod.

14. An apparatus for alignment of vertebrae, comprising: a surgical rod having a first cross-sectional shape;

0 a hook-shaped member adapted and configured for receiving a portion of bone within the hook; a cable coupling said hook-shaped member to said rod and having first and second ends; and a connecting member having a first extended portion connected to the first end of [5 said cable and a second extended portion connected to the second end of said cable, and having a middle section between the first and second extended portions, the middle section having a second cross-sectional shape generally complementary to the cross-sectional shape of said rod.

0 15. The apparatus of claim 14 wherein tightening of said cable brings the middle section into contact with said rod.

16. The apparatus of claim 14 which further comprises an anchor adapted and configured for fixation into a bone, said anchor coupling said hook-shaped member 5 to a bone.

17. The apparatus of claim 16 wherein said anchor is a bone screw having a threaded shank and a head and said hook-shaped member defines an aperture therethrough to accept the shank. 0

18. The apparatus of claim 17 wherein said anchor is a bone screw having a threaded shank and a head with a curved shoulder, and said hook-shaped member defines an aperture therethrough with a curved wall to accept the curved shoulder.

5 19. The apparatus of claim 14 wherein said hook-shaped member includes an arm and said arm defines a hole, said hole being open at both ends and enclosed therebetween, a portion of said cable being passing through the hole.

20. An apparatus for alignment of vertebrae, comprising: 0 a surgical rod; a hook-shaped member including first and second arms connected at one end and spaced apart at the other end to form a pocket therebetween for receiving a portion of bone, one of said arms defining an open slot; a bone anchor coupling said hook-shaped member to a bone; [5 a cable coupling said hook-shaped member to said rod and having first and second ends, a portion of said cable being received within the open slot; and a connecting member having a first extended portion connected to the first end of said cable and a second extended portion connected to the second end of said cable and a middle section between the first extended portion and the second extended portion. 0

21. The apparatus of claim 20 wherein the other of said arms defines an aperture and a portion of said bone anchor passes through the aperture.

22. The apparatus of claim 20 wherein the one of said arms defines an aperture 5 and a portion of said bone anchor passes through the aperture.

23. The apparatus of claim 20 wherein the middle section spaces apart said first and second extended portions such that said cable does not contact said rod after tightening. 0

24. The apparatus of claim 20 wherein said surgical rod has a first width and said connecting member has a second width, and the second width is greater than the first width.

25. The apparatus of claim 20 wherein said surgical rod has a first width and the middle section of said connecting member has a second width, and the second width is about the same as the first width.

26. The apparatus of claim 20 wherein said surgical rod has an outer surface and said first extended portion is not in contact with the outer surface, said second extended portion is not in contact with the outer surface, and said middle section is in contact with the outer surface.

27. An apparatus for alignment of vertebrae, comprising: a surgical rod; a bone anchor having a head and a body adapted and configured for fixation into a bone, said head defining an aperture therethrough; a cable coupling said bone anchor to said rod and having first and second ends, a portion of said cable passing through the aperture; and a connecting member having a first extended portion connected to the first end of said cable and a second extended portion connected to the second end of said cable and a middle section between the first extended portion and the second extended portion, wherein the middle section spaces apart said first and second extended portions such that said cable does not contact said rod after tightening.