US20100331887A1 - Longitudinal connecting member with sleeved tensioned cords - Google Patents

Abstract

A dynamic fixation medical implant having at least two bone anchors includes a longitudinal connecting member assembly having rigid sleeves for attachment to the bone anchors, at least one spacer engaging the bone anchors and the sleeves, and in some embodiments, an end elastic bumper. A flexible cord is initially slidingly received within the rigid sleeves, the spacer and the bumper. The spacer may include an optional inelastic inner liner, with at least one of the sleeves having an extension slidingly receivable within the liner. Some sleeves include apertures for receiving a closure top portion for locking the cord against the sleeve, or alternatively receiving a closure top that does not extend into the aperture, the slip or grip option provided by the aperture in each sleeve resulting in an overall connector with variable segmental stiffness.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of the following U.S. Provisional Patent Application Ser. Nos. 61/268,708, filed Jun. 15, 2009; 61/270,754, filed Jul. 13, 2009; 61/336,911 filed Jan. 28, 2010; 61/395,564 filed May 14, 2010; 61/395,752 filed May 17, 2010; and 61/396,390 filed May 26, 2010 (docket no. 11,183); all of which are incorporated by reference herein. This application is also a continuation-in-part of U.S. patent application Ser. No. 12/221,442 filed Aug. 1, 2008 that is a continuation-in-part of U.S. patent application Ser. No. 11/328,481 filed Jan. 9, 2006, both of which are also incorporated by reference herein. This application is also a continuation-in-part of U.S. patent application Ser. No. 12/148,465 filed Apr. 18, 2008 that claims the benefit of U.S. Provisional Patent Application Ser. No. 60/927,111 filed May 1, 2007, both of which are incorporated by reference herein. This application is also a continuation-in-part of U.S. patent application Ser. No. 12/661,042 filed Mar. 10, 2010 that claims the benefit of U.S. Provisional Patent Application Ser. No. 61/210,058 filed Mar. 13, 2009, both of which are incorporated by reference herein.
BACKGROUND OF THE INVENTION
• The present invention is directed to dynamic fixation assemblies for use in bone surgery, particularly spinal surgery, and in particular to longitudinal connecting members and cooperating bone anchors or fasteners for such assemblies, the connecting members being attached to at least two bone anchors.
• Historically, it has been common to fuse adjacent vertebrae that are placed in fixed relation by the installation therealong of bone screws or other bone anchors and cooperating longitudinal connecting members or other elongate members. Fusion results in the permanent immobilization of one or more of the intervertebral joints. Because the anchoring of bone screws, hooks and other types of anchors directly to a vertebra can result in significant forces being placed on the vertebra, and such forces may ultimately result in the loosening of the bone screw or other anchor from the vertebra, fusion allows for the growth and development of a bone counterpart to the longitudinal connecting member that can maintain the spine in the desired position even if the implants ultimately fail or are removed. Because fusion has been a desired component of spinal stabilization procedures, longitudinal connecting members have been designed that are of a material, size and shape to largely resist bending (flexion, extension and lateral), torsion, shear, distraction and compression, and thus substantially immobilize the portion of the spine that is to be fused. Thus, longitudinal connecting members are typically uniform along an entire length thereof, and usually made from a single or integral piece of material having a uniform diameter or width of a size to provide substantially inelastic rigid support in all planes.
• An alternative to fusion, which immobilizes at least a portion of the spine, and the use of more rigid longitudinal connecting members or other rigid structure has been a “soft” or “dynamic” stabilization approach in which a flexible loop-, S-, C- or U-shaped member or a coil-like and/or a spring-like member is utilized as an elastic longitudinal connecting member fixed between a pair of pedicle screws in an attempt to create, as much as possible, a normal loading pattern between the vertebrae in flexion, extension, side bending, distraction, compression and torsion. Another type of soft or dynamic system known in the art includes bone anchors connected by flexible cords or strands, typically made from a plastic material. Such a cord or strand may be threaded through cannulated spacers that are disposed between adjacent bone anchors when such a cord or strand is implanted, tensioned and attached to the bone anchors. The spacers typically span the distance between bone anchors, providing limits on the bending movement of the cord or strand and thus strengthening and supporting the overall system. Shear forces are not well resisted by the typical cord and spacer stabilization systems. Such tensioned cord and spacer systems may also cause facet joint compression during spinal movement, especially flexion.
• The complex dynamic conditions associated with spinal movement create challenges for the design of elongate elastic longitudinal connecting members that exhibit an adequate fatigue strength to provide stabilization and protected motion of the spine, without fusion, and that allow for some natural movement of the portion of the spine being reinforced and supported by the elongate elastic or flexible connecting member. A further challenge are situations in which a portion or length of the spine requires a more rigid stabilization, possibly including fusion, while another portion or length may be better supported by a more dynamic system that allows for protective movement.
SUMMARY OF THE INVENTION
• Longitudinal connecting member assemblies according to the invention for use between at least two bone anchors provide dynamic, protected motion of the spine and may be extended to provide additional dynamic sections or more rigid support along an adjacent length of the spine, with fusion, if desired. A dynamic longitudinal connecting member assembly according to the invention has an inner segment or core made from a cord in the disclosed embodiment, the core being tensioned and fixed at either end of the assembly. The core is received by at least one hard, inelastic segment or sleeve, the sleeve attachable to at least one bone anchor. In some embodiments, the core is received by at least a pair of such sleeves, each sleeve attachable to a bone anchor. In some embodiments, the sleeve or sleeves slidingly receive the core. In other embodiments, the sleeve or sleeves are either fixed or left unfixed to the core by the surgeon, resulting in a connecting member having variable segmental stiffness along a length thereof. A variety of embodiments according to the invention are possible. Additional sleeves may be attached to additional bone anchors and cooperate with additional cut-to-length spacers with or without cooperating liners to create longer assemblies. Sleeves may also be extended to provide inelastic rod, bar or tube extensions, especially on one end. Spacers and optional cooperating liners with different measures of rigidity may be connected according to embodiments of the invention. Either rigid lengths or cords may be of greater or lesser lengths for attaching to one or a plurality of bone anchors. In some embodiments, longitudinal connecting member assemblies may be dynamically loaded before insertion, or after being operatively attached to at least the pair of bone anchors along a patient's spine by tensioning the inner core and at least partially compressing an end bumper and/or at least one spacer located between the bone anchors. Typically, the at least one spacer with or without an inner liner has some flexibility in bending, with the spacer/liner combination protecting and limiting flexing movement of the inner core and providing shear resistance.
• An object of the invention is to provide a lightweight, reduced volume, low profile assemblies for use with at least two bone anchors. Furthermore, it is an object of the invention to provide apparatus and methods that are easy to use and especially adapted for the intended use thereof and wherein the apparatus are comparatively inexpensive to make and suitable for use.
• Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention.
• The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a longitudinal connecting member according to the invention having a tensioned cord and a pair of sleeves, each sleeve shown cooperating with a polyaxial bone screw.
• FIG. 1ais a perspective view of an alternative embodiment of a longitudinal connecting member according to the invention shown with one monoaxial screw clamped directly to an inner tensioned cord and one polyaxial screw having a sleeve for slidable engagement with the cord.
• FIG. 2 is a perspective view of the connecting member ofFIG. 1 shown without the polyaxial bone screws, the connecting member including an inner cord, first and second sleeves, a spacer/liner combination, an elastic bumper and a cord blocker with set screw, all shown prior to tensioning.
• FIG. 3 is a top plan view of the connecting member ofFIG. 2.
• FIG. 4 is a reduced exploded view of the connecting member ofFIG. 2.
• FIG. 5 is an enlarged perspective view of the first sleeve ofFIG. 2.
• FIG. 6 is an enlarged top plan view of the first sleeve ofFIG. 5.
• FIG. 7 is an enlarged rear elevational view of the first sleeve ofFIG. 5.
• FIG. 8 is an enlarged cross-sectional view taken along the line8-8 ofFIG. 6.
• FIG. 9 is an enlarged side elevational view of the liner of the spacer/liner combination ofFIG. 2.
• FIG. 10 is an enlarged rear elevational view of the liner ofFIG. 9.
• FIG. 11 is an enlarged front elevational view of the liner ofFIG. 9.
• FIG. 12 is an enlarged perspective view of the liner ofFIG. 9.
• FIG. 13 is an enlarged side elevational view of the spacer of the spacer/liner combination ofFIG. 2.
• FIG. 14 is an enlarged rear elevational view of the spacer ofFIG. 13.
• FIG. 15 is an enlarged front elevational view of the spacer ofFIG. 13.
• FIG. 16 is an enlarged perspective view of the spacer ofFIG. 13.
• FIG. 17 is an enlarged cross-sectional view taken along the line17-17 ofFIG. 14.
• FIG. 18 is an enlarged perspective view of the second sleeve shown inFIG. 2.
• FIG. 19 is en enlarged top plan view of the second sleeve ofFIG. 18.
• FIG. 20 is an enlarged front elevational view of the second sleeve ofFIG. 18.
• FIG. 21 is an enlarged rear elevational view of the second sleeve ofFIG. 18.
• FIG. 22 is an enlarged cross-sectional view taken along the line22-22 ofFIG. 19.
• FIG. 23 is an enlarged side elevational view of the bumper shown inFIG. 2.
• FIG. 24 is an enlarged rear elevational view of the bumper ofFIG. 23.
• FIG. 25 is an enlarged front elevational view of the bumper ofFIG. 23.
• FIG. 26 is an enlarged cross-sectional view taken along the line26-26 ofFIG. 25.
• FIG. 27 is an enlarged side elevational view of the blocker and set screw shown inFIG. 2.
• FIG. 28 is an enlarged rear elevational view of the blocker ofFIG. 27.
• FIG. 29 is an enlarged front elevational view of the blocker and set screw ofFIG. 27.
• FIG. 30 is an enlarged cross-sectional view taken along the line30-30 ofFIG. 28.
• FIG. 301ais an enlarged perspective view of the blocker and set screw ofFIG. 27 shown pre-assembled with the bumper ofFIG. 23.
• FIG. 31 is an enlarged and partial perspective view of the connector and bone screws ofFIG. 1 further showing a first bone screw in exploded view, the bone screw including a bone screw shank, retainer, receiver, compression insert and closure top.
• FIG. 32 is an enlarged and partial cross-sectional view taken along the line32-32 ofFIG. 31.
• FIG. 33 is an enlarged perspective view of the receiver of the first bone screw ofFIG. 31.
• FIG. 34 is an enlarged side elevational view of the receiver ofFIG. 33 with portions broken away to show the detail thereof.
• FIG. 35 is an enlarged and partial perspective exploded view of the receiver and compression insert of the first bone screw ofFIG. 31, shown in an initial stage of assembly.
• FIG. 36 is an enlarged and partial perspective view of the receiver and compression insert ofFIG. 35 with portions broken away to show the detail thereof and shown in a later stage of assembly.
• FIG. 37 is an enlarged and partial cross-sectional view taken along the line37-37 ofFIG. 1.
• FIG. 38 is an enlarged perspective view of another embodiment of a dynamic fixation longitudinal connecting member according to the invention shown attached to three polyaxial bone screws.
• FIG. 39 is a side elevational view of the connecting member ofFIG. 38 shown without the polyaxial bone screws, the connecting member including an inner cord, three sleeves, two spacer/liner combinations (shown in phantom), an elastic bumper (shown in phantom) and a cord blocker with set screw.
• FIG. 40 is an enlarged perspective view of one of the sleeves ofFIG. 39.
• FIG. 41 is an enlarged rear elevational view of the sleeve ofFIG. 40.
• FIG. 42 is an enlarged front elevational view of the sleeve ofFIG. 40.
• FIG. 43 is an enlarged cross-sectional view taken along the line43-43 ofFIG. 41.
• FIG. 44 is an enlarged and partial cross-sectional view, similar toFIG. 37, but showing an alternative assembly with sleeves having apertures for receiving closure top portions therein to grip the inner core.
• FIG. 45 is an enlarged front elevational view of another alternative longitudinal connecting member according to the invention shown attached to a pair of polyaxial bone screws.
• FIG. 46 is an enlarged perspective view of the connecting member ofFIG. 45.
• FIG. 47 is an enlarged and exploded perspective view of the connecting member ofFIG. 45 shown without the polyaxial bone screws, the connecting member including an inner cord, first and second sleeves, a spacer/liner combination, an elastic bumper and a cord blocker with set screw.
• FIG. 48 is an enlarged perspective view of the connecting member ofFIG. 47 shown with the components loosely connected along the inner cord and prior to tensioning.
• FIG. 49 is an enlarged side elevational view of the first sleeve ofFIG. 48.
• FIG. 50 is an enlarged perspective view of the first sleeve ofFIG. 49.
• FIG. 51 is an enlarged front elevational view of the first sleeve ofFIG. 49.
• FIG. 52 is an enlarged rear elevational view of the first sleeve ofFIG. 49.
• FIG. 53 is an enlarged cross-sectional view taken along the line53-53 ofFIG. 49.
• FIG. 54 is an enlarged exploded perspective view of the spacer/liner combination ofFIG. 47.
• FIG. 55 is an enlarged perspective view of the spacer/liner combination ofFIG. 54 shown assembled.
• FIG. 56 is an enlarged front elevational view of the spacer/liner combination ofFIG. 55.
• FIG. 57 is an enlarged cross-sectional view taken along the line57-57 ofFIG. 55.
• FIG. 58 is an enlarged perspective view of the second sleeve shown inFIG. 47.
• FIG. 59 is en enlarged rear elevational view of the second sleeve ofFIG. 58.
• FIG. 60 is an enlarged front elevational view of the second sleeve ofFIG. 58.
• FIG. 61 is an enlarged cross-sectional view taken along the line61-61 ofFIG. 58.
• FIG. 62 is an enlarged exploded perspective view of the bumper, blocker and set screw shown inFIG. 47.
• FIG. 63 is an enlarged front elevational view of the bumper ofFIG. 62.
• FIG. 64 is an enlarged side elevational view of the bumper, blocker and set screw ofFIG. 62 shown assembled.
• FIG. 65 is an enlarged perspective view of the bumper, blocker and set screw ofFIG. 64.
• FIG. 66 is an enlarged front elevational view of the bumper, blocker and set screw ofFIG. 64.
• FIG. 67 is an enlarged rear elevational view of the bumper, blocker and set screw ofFIG. 64.
• FIG. 68 is an enlarged cross-sectional view taken along the line68-68 ofFIG. 66.
• FIG. 69 is an enlarged and partial perspective view of the connector and bone screws ofFIG. 45 further showing a bone screw in exploded view, the bone screw including a bone screw shank, retainer, receiver, compression insert and closure top.
• FIG. 70 is an enlarged and partial and partially exploded side elevational view of the connector and bone screws, similar toFIG. 69, with portions broken away to show the detail thereof and the retainer and shank shown in a stage of assembly.
• FIG. 71 is an enlarged and partial cross-sectional view taken along the line71-71 ofFIG. 69.
• FIG. 72 is an enlarged and partial front elevational view of the assembly ofFIG. 45 with portions broken away to show the detail thereof.
• FIG. 73 is an enlarged perspective view of the bone screw shank ofFIG. 69.
• FIG. 74 is an enlarged top plan view of the shank ofFIG. 73.
• FIG. 75 is an enlarged and partial side elevational view of the shank ofFIG. 73 with portions broken away to show the detail thereof.
• FIG. 76 is an enlarged perspective view of the retainer ofFIG. 69.
• FIG. 77 is a top plan view of the retainer ofFIG. 69.
• FIG. 78 is a bottom plan view of the retainer ofFIG. 69.
• FIG. 79 is a cross-sectional view taken along the line79-79 ofFIG. 77.
• FIG. 80 is an enlarged and partial front elevational view of the shank and retainer ofFIG. 69 shown in an early stage of assembly.
• FIG. 81 is an enlarged and partial side elevational view of an assembled shank, retainer and receiver ofFIG. 69 with portions broken away to show the detail thereof.
• FIG. 82 is another enlarged and partial side elevational view of an assembled shank, retainer and receiver ofFIG. 69 with portions broken away to show the detail thereof.
• FIG. 83 is a cross-sectional view taken along the line83-83 ofFIG. 82.
• FIG. 84 is an enlarged side elevational view of the compression insert ofFIG. 69.
• FIG. 85 is an enlarged top plan view of the compression insert ofFIG. 69.
• FIG. 86 is an enlarged bottom plan view of the compression insert ofFIG. 69.
• FIG. 87 is an enlarged and partial perspective view of the receiver and compression insert ofFIG. 69 shown in an early stage of assembly.
• FIG. 88 is an enlarged and partial perspective view of the receiver and compression insert ofFIG. 87 shown in a later stage of assembly and with portions broken away to show the detail thereof.
• FIG. 89 is an enlarged front elevational view of another embodiment of a longitudinal connecting member according to the invention shown attached to three polyaxial bone screws.
• FIG. 90 is a side elevational view of the connecting member ofFIG. 89 with portions broken away to show the detail thereof, including an inner cord, three sleeves, two spacer/liner combinations, an elastic bumper and a cord blocker with set screw.
• FIG. 91 is an enlarged perspective view of one of the sleeves ofFIG. 90.
• FIG. 92 is an enlarged rear elevational view of the sleeve ofFIG. 91.
• FIG. 93 is an enlarged front elevational view of the sleeve ofFIG. 91.
• FIG. 94 is an enlarged cross-sectional view taken along the line94-94 ofFIG. 92.
• FIG. 95 is a reduced perspective view of a kit showing various lengths and configurations of sleeves according to the invention.
• FIG. 96 is a perspective view of another longitudinal connecting member according to the invention shown attached to five polyaxial bone screws.
• FIG. 97 is an exploded perspective view of the connecting member ofFIG. 96 shown without the polyaxial bone screws, the connecting member including an inner cord, first, second and third sleeves, first and second spacer/liner combinations, a third spacer, an elastic bumper, a cord blocker with set screw, a rod/cord coupler and a threaded rod.
• FIG. 98 is a front elevational view of one of the bone screws shown inFIG. 96 with portions broken away to show cooperation with the connecting member ofFIG. 96, also with portions broken away.
• FIG. 99 is a front elevational view of the connector and bone screws ofFIG. 96 with portions broken away to show the detail thereof and showing three different types of closure tops.
• FIG. 100 is an enlarged perspective view of the first sleeve shown inFIG. 97.
• FIG. 101 is a reduced side elevational view of the sleeve ofFIG. 100.
• FIG. 102 is a reduced top plan view of the sleeve ofFIG. 100.
• FIG. 103 is a reduced bottom plan view of the sleeve ofFIG. 100.
• FIG. 104 is a cross-sectional view taken along the line60-60 ofFIG. 100.
• FIG. 105 is an enlarged perspective view of the second sleeve shown inFIG. 97.
• FIG. 106 is an alternative perspective view of the sleeve ofFIG. 105.
• FIG. 107 is a side elevational view of the sleeve ofFIG. 105 with portions broken away to show the detail thereof.
• FIG. 108 is an enlarged perspective view of the third sleeve shown inFIG. 97.
• FIG. 109 is an alternative perspective view of the sleeve ofFIG. 108.
• FIG. 110 is a side elevational view of the sleeve ofFIG. 108 with portions broken away to show the detail thereof.
• FIG. 111 is an enlarged perspective view of the rod/cord coupler ofFIG. 97.
• FIG. 112 is a side elevational view of the rod/cord coupler ofFIG. 111 with portions broken away to show the detail thereof.
• FIG. 113 is an enlarged perspective view the cord blocker ofFIG. 97.
• FIG. 114 is a side elevational view of the cord blocker ofFIG. 113 with portions broken away to show the detail thereof.
• FIG. 115 is a side elevational view of another embodiment of a longitudinal connecting member according to the invention shown attached to five polyaxial bone screws.
• FIG. 116 is an enlarged and partial side elevational view of the connecting member ofFIG. 115 with portions broken away to show the detail thereof.
• FIG. 117 is an enlarged front elevational view of one of the closure tops shown inFIG. 99.
• FIG. 118 is a front elevational view of the closure top ofFIG. 117 with portions broken away to show the detail thereof.
• FIG. 119 is an enlarged front elevational view of another of the closure tops shown inFIG. 99.
• FIG. 120 is a front elevational view of the closure top ofFIG. 119 with portions broken away to show the detail thereof.
• FIG. 121 is an enlarged front elevational view of another of the closure tops shown inFIG. 99.
• FIG. 122 is a front elevational view of the closure top ofFIG. 121 with portions broken away to show the detail thereof.
• FIG. 123 is a perspective view of another sleeve according to the invention shown mounted within a polyaxial bone screw.
• FIG. 124 is an enlarged and partial exploded perspective view of the assembly and sleeve ofFIG. 123.
• FIG. 125 is an enlarged and partial front elevational view of the assembly and sleeve ofFIG. 123.
• FIG. 126 is a cross-sectional view taken along the line126-126 ofFIG. 125.
• FIG. 127 is an enlarged top plan view of the sleeve ofFIG. 123.
• FIG. 128 is an enlarged bottom plan view of the sleeve ofFIG. 123.
• FIG. 129 is a front elevational view of the assembly ofFIG. 123 with portions broken away to show the detail thereof.
• FIG. 130 is a partial side elevational view of the bone screw ofFIG. 123 shown with an alternative lordotic sleeve of the invention.
• FIG. 131 is an enlarged side elevational view of the sleeve ofFIG. 130 with portions broken away to show the detail thereof.
• FIG. 132 is a perspective view of a set of sleeves as shown inFIGS. 123-131.
• FIG. 133 is a partially exploded perspective view of a longitudinal connecting member including the assembly further including some of the sleeves ofFIG. 132.
• FIG. 134 is an enlarged front elevational view of one of the sleeves shown inFIG. 132 with portions broken away to show the detail thereof, the sleeve also including a cord fixer and a solid rod.
• FIG. 135 is a top plan view of the sleeve ofFIG. 134.
• FIG. 136 is a bottom plan view of the sleeve ofFIG. 134.
• FIG. 137 is a perspective view of another alternative sleeve according to the invention.
• FIG. 138 is a top plan view of the sleeve ofFIG. 137.
• FIG. 139 is a cross-sectional view taken along the line139-139 ofFIG. 138.
• FIG. 140 is an exploded front elevational view of another sleeve according to the invention shown with a polyaxial bone screw and a pair of alternative closure tops.
• FIG. 141 is a perspective view of a set of sleeves, one of which is shown inFIG. 140.
• FIG. 142 is an enlarged perspective view of one of the sleeves ofFIG. 141 that is also the sleeve shown inFIG. 140.
• FIG. 143 is a top plan view of the sleeve ofFIG. 142.
• FIG. 144 is a bottom plan view of the sleeve ofFIG. 142.
• FIG. 145 is a cross-sectional view taken along the line145-145 ofFIG. 143.
• FIG. 146 is a partial perspective view of the assembly ofFIG. 140 with portions broken away to show the detail thereof.
• FIG. 147 is a partial front elevational view of the assembly ofFIG. 146.
• FIG. 148 is a partial perspective view of the bone screw assembly ofFIG. 140 shown with one of the lordotic sleeve illustrated inFIG. 141.
• FIG. 149 is a partial front elevational view of the assembly ofFIG. 148.
• FIG. 150 is an enlarged and partial front elevational view, similar toFIG. 149 with portions broken away to show the detail thereof.
• FIG. 151 is a top plan view of one of the sleeves illustrated inFIG. 141 that further includes an elongate rod.
• FIG. 152 is a cross-sectional view taken along the line152-152 ofFIG. 151.
• FIG. 153 is a front elevational view of the sleeve ofFIG. 151.
• FIG. 154 is a reduced and partial and partially exploded side elevational view of a plurality of bone screws ofFIG. 140 shown with various sleeves similar to that shown inFIG. 140, the sleeves having various lengths of tubal extensions thereon, and further shown with a sleeve similar to the sleeve ofFIG. 151 and also a cord, bumper/blocker, spacers and various closure tops.
DETAILED DESCRIPTION OF THE INVENTION
• As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. It is also noted that any reference to the words top, bottom, up and down, and the like, in this application refers to the alignment shown in the various drawings, as well as the normal connotations applied to such devices, and is not intended to restrict positioning of the connecting member assemblies of the application and cooperating bone anchors in actual use.
• With reference toFIGS. 1-44, thereference numeral1 generally designates a non-fusion dynamic stabilization longitudinal connecting member assembly according to the present invention. The connectingmember assembly1 is elongate, having a substantially central axis A. With particular reference toFIGS. 1-4, the illustrated connectingmember assembly1 generally includes at least first and second hard,inelastic sleeves5 and7 with an optional spacer/liner combination, generally10, located therebetween. In particular, the spacer/liner combination10 includes anouter spacer12 and aninner liner13. Theassembly1 further includes anelastic bumper16, acord blocker18 with cooperating setscrew19 and an inner core that in the present embodiment is acord22. Thecord22 extends along the axis A and successively through and within thesleeve5, thespacer12, the sleeve7 (and optional spacer/liner10), thebumper16 and thecord blocker18 as shown, for example, inFIG. 37. InFIGS. 1 and 37, theassembly1 is shown attached to two polyaxial bone screws, generally25 at thesleeves5 and7. A portion of thesleeve7 extends into and through the spacer/liner10 and is in slidable relationship therewith. A portion of thecord blocker18 extends into a bore of thebumper16. As will be described and explained in greater detail below, thebumper16 is typically made from an elastomer while theouter spacer12 is also elastomeric, but typically made from a material with a different durometer, being tougher and less compressible than the material of thebumper16. Furthermore, thesleeves5 and7 and thespacer liner13 are made from a hard, non-elastic material, such as a metal or metal alloy, like cobalt chromium. The hard and stiff slidingsleeve7 includes an extension that slides into theliner13, providing a dynamic no- or low-wear, sliding relationship between thesleeve7 and theliner13 that is non-binding, and provides excellent shear resistance while at the same time, the optionalthin liner13 cooperating with theelastomeric spacer12 as well as the tensionedcord22 provide controlled bending, with the tensionedcord22 andcompressed bumper16, performing well under tension and compression. Portions of thesleeves5 and7 are disposed flush to side surfaces of the cooperating bone screws25 that abut against thespacer12 or thebumper16, such flush surface geometry results in stable, secure substantially full contact between such outer elements of theassembly1 and the cooperating bone screws. In certain embodiments of the invention, thesleeves5 and7 may further includerespective openings27 and28 (shown in phantom in the drawings with the exception ofFIG. 44) sized and shaped to receive a portion of a closure top therethrough for gripping thecord22 when desired by the surgeon.Such openings27 and28 and cooperating closure tops will be described in greater detail below with respect toFIGS. 100-110 and117-118, for example. With particular reference toFIG. 44, when a longitudinal connecting member according to the invention includes two ormore sleeves5′ and/or7′ equipped with closure top receiving openings, theopenings27 and28 allow a surgeon to decide whether to allow thecord22 to slide or slip with respect to theparticular sleeve5′ or7′ or to be gripped withinsuch sleeve5′ or7′, advantageously providing for variable segmental stiffness along a length of a longitudinal connecting member, and thus custom-made for the needs of the individual patient. Whensleeves5′ and7′ havingrespective openings27 and28 are utilized in a longitudinal connecting member, thebumper16 andcord blocker18/set screw19 combination is an optional component and thus may or may not be included in such a longitudinal connecting member assembly as thecord22 may be fixed in place at asleeve5′ or7′ located near an end of such assembly. It is noted that thesleeves5 and7 may also include tubular extensions of varying lengths on one or both sides thereof (not shown), but as otherwise shown and described with respect to other sleeves of the invention, for example, onFIG. 132. With reference toFIG. 1a, and as will be described in greater detail below, it is noted thatsleeves5 and5′ and7 and7′ according to the invention may be used with or without abumper16, but may cooperate with one ormore blockers18. As stated elsewhere herein, connecting members of the invention may or may not includebumpers16 orblockers18. Furthermore, asingle sleeve5,5′,7 or7′ (or other sleeves described herein) may be used in a longitudinal connecting member according to the invention, cooperating with one or more other bone anchors (mono- or polyaxial) that do not engage a sleeve, but rather fixedly or slidingly cooperate directly with the tensioned cord (also shown inFIG. 1aand described in greater detail below).
• With particular reference toFIGS. 5-8, the sleeve further includes abody portion30 generally sized and shaped for being received within thepolyaxial bone screw25 and atubular extension32 sized and shaped to engage and hold thespacer12 in fixed engagement with thesleeve5. The illustratedbody portion30 andtubular extension32 are integral or otherwise fixed to one another. A throughbore34 extends through a lower portion of thebody portion30 and centrally through thetubular extension32. Thebore34 is sized and shaped to slidingly receive thecord22 and when assembled with a remainder of theassembly1 extends along the axis A. Thebody portion30 includes an outer side andlower surface36 that is substantially U-shaped in cross-section, being sized and shaped to fit within a U-shaped opening of thebone screw25 as will be described in greater detail below. A substantial portion of thesurface36 terminates at an upperplanar surface38, with the U-shaped surface extending on either side of theplanar surface38 into upwardly extending arms orflanges40 and42.Inner surfaces44 and46 of therespective arms40 and42 form a discontinuous cylindrical wall sized and shaped to receive a closure top of thebone screw25 as will be described in greater detail below. Theplanar surface38 is also a seating surface for the bone screw closure top. As will be described in greater detail below, thearms40 and42 and theU-shaped body36 are sized and shaped to fit within the receiver of thebone screw25 and resist rotation and other forces placed on thesleeve5. However, it is noted that in some embodiments, thesleeve5 may be substantially cylindrical in outer form and thus receivable within a variety of fixed or polyaxial screw heads, such as will be described below with respect toFIGS. 45-95. In the embodiment illustrated inFIGS. 1-44, thearms40 and42 that are received within thepolyaxial screw25 terminate at respective upperplanar surfaces48 and50. Thearms40 and42 further include respective substantially planar outer or endsurfaces52 and54, such surfaces being operatively flush with surfaces of thebone screw25 as will be described more fully below. Theouter surface52 is also an end surface of thesleeve5, extending from thearm40top surface48 downwardly and around thebore34 and running adjacent and perpendicular to the U-shapedouter surface36. Thesurface52 is adjacent to a flared orbeveled surface53 that defines an opening of thebore34. Theouter surface54 is adjacent to a taperedsurface55 that extends toward and terminates at a firstcylindrical surface56 of thetubular extension32. The outercylindrical surface56 terminates at a radially extendingannular wall58 that is perpendicular thereto. Thewall58 terminates at a second substantiallycylindrical surface60 of greater outer diameter than thecylindrical surface56. Thesurface60 terminates at an annular inwardly tapering beveledsurface62. Thebevel62 is adjacent to a planarannular end surface64 that is disposed perpendicular to thecylindrical surface60. Thesurface64 is adjacent to a flared orbeveled surface65 that defines an opening of thebore34. Thesurfaces56,58 and60 provide a push-on connective element for attachment to inner surfaces of thespacer12 as will be described in greater detail below. Thesleeve5, as well as thesleeve7, theliner13 and thecord blocker18 withset screw19 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• With particular reference to FIGS.4 and13-17, thespacer12 is substantially cylindrical and tubular in form, having an outercylindrical surface70 and an inner, graduated through bore, generally72. Thespacer12 has opposed substantially planar annular end surfaces74 and76. Thebore72 is defined in part by a first innercylindrical surface78 that begins at thesurface76 and extends substantially along a length of thespacer12. Thesurface78 closely receives theinner liner13 thereon. In fact, thespacer12/liner13 combination is typically assembled or manufactured with theliner13 being fixed to thesurface78 such that a surgeon receives thespacer12/liner13 combination already assembled and ready for the surgeon to cut thespacer12/liner13 combination to a desired length near theend76 as will be described in greater detail below. Adjacent theend74, thespacer12 includes a flared or beveled openingsurface80 extending to an innercylindrical surface82 having an inner diameter smaller than thecylindrical surface78. A third innercylindrical surface84 is located between thesurface82 and thesurface78, thesurface84 having a diameter larger than thesurface82 and smaller than thesurface78. Acurved transition surface86 spans between thecylindrical surfaces82 and84 and acurved transition surface88 spans between thecylindrical surfaces84 and78. Portions of the transition surfaces86 and88 are substantially perpendicular to thecylindrical surfaces78,82 and84. As will be described in greater detail below, when thespacer12/liner13 combination is pushed onto thetubular extension32 of thesleeve5 during assembly, the flaredsurface80 of the spacer engages the taperedsurface55 of the sleeve, the innercylindrical surface82 engages the outercylindrical surface56 of the sleeve, thesurface86 of the spacer engages thesurface58 of the sleeve, and the innercylindrical surface84 of the spacer engages the outercylindrical surface60 of thetubular extension32. As best shown inFIG. 37, the close fit between the spacer innercylindrical surfaces82 and84 and thetubular extension32 of thesleeve5, provide a secure, fixed positioning of thespacer12 with respect to thesleeve5 along the axis A, prohibiting thespacer12 from being pulled away from thesleeve surface54 during spinal movement. However, some relative rotational movement between thespacer12 and thesleeve5 about the axis A is possible, allowing for some twist or turn, providing some relief for torsional stresses. Thespacer12 is typically elastic and made from a plastic, for example, a thermoplastic elastomer made from a polyurethane or polyurethane blend, such as a polycarbonate urethane.
• With particular reference toFIGS. 9-12, the optionalinelastic liner13 is substantially cylindrical and tubular in form, having an outercylindrical surface90 and an inner cylindrical throughbore92. Theliner13 has opposed annular end surfaces94 and96. As best shown inFIG. 37, theend surface94 abuts against theannular surface88 of thespacer12 and the outercylindrical surface90 is adhered or otherwise fixed to the innercylindrical surface78 of thespacer12. Theend surface96 is disposed flush to theend surface76 of thespacer12, these surfaces being the cut-to-length side of thespacer12/liner13 combination as will be described in greater detail below. As previously stated, although shown as a separate part or element in the drawings, when used, theoptional liner13 is typically provided pre-assembled within thespacer12. Theliner13 may be made from a variety of non-elastic materials, including metals, metal alloys and some plastics, with cobalt chromium being a preferred material. The innercylindrical surface92 is sized and shaped to slidingly receive a tubular extension of theinelastic sleeve7 as will be described in greater detail below.
• With particular reference toFIGS. 18-22, thesleeve7 includes abody portion99 generally sized and shaped for being received within thepolyaxial bone screw25 and atubular extension100 sized and shaped to be slidingly received in thespacer12/liner13 combination. The illustratedbody portion99 andtubular extension100 are integral or otherwise fixed to one another. More than one size ofsleeve7 is typically provided to the surgeon, thesleeves7 differing only in the length of thetubular extension100, so as to appropriately match the size of the patient's spine. A throughbore104 extends through a lower portion of thebody portion99 and centrally through thetubular extension100. Thebore104 is sized and shaped to slidingly receive thecord22 and when assembled with a remainder of theassembly1 extends along the axis A. Thebody portion99 includes an outer side andlower surface106 that is substantially U-shaped in cross-section, being sized and shaped to fit within a U-shaped opening of thebone screw25 as will be described in greater detail below. A substantial portion of thesurface106 terminates at an upperplanar surface108, with the U-shaped surface extending on either side of theplanar surface108 into upwardly extending arms orflanges110 and112.Inner surfaces114 and116 of therespective arms110 and112 form a discontinuous cylindrical wall sized and shaped to receive a closure top of thebone screw25 as will be described in greater detail below. Theplanar surface108 is also a seating surface for the bone screw closure top. As will be described in greater detail below, thearms110 and112 and theU-shaped body106 are sized and shaped to fit within the receiver of thebone screw25 and resist rotation and other forces placed on thesleeve7. However, it is noted that in some embodiments, thesleeve7 may be substantially cylindrical in outer form and thus receivable within a variety of fixed or polyaxial screw heads. In the illustrated embodiment, thearms110 and112 that are received within thepolyaxial screw25 terminate at respective upperplanar surfaces118 and120. Thearms110 and112 further include respective substantially planar outer or endsurfaces122 and124, such surfaces being operatively flush with side surfaces of thebone screw25 as will be described more fully below. Theouter surface124 is also an end surface of thesleeve7, extending from thearm112top surface120 downwardly and around thebore104 and running adjacent and perpendicular to the U-shapedouter surface106. Thesurface124 is adjacent to a flared orbeveled surface125 that defines an opening of thebore104. Theouter surface122 is adjacent to atapered surface126 that extends toward and terminates at acylindrical surface127 of thetubular extension100. The outercylindrical surface127 extends toward an annularplanar end surface128 that is perpendicular thereto. Abeveled surface130 spans between thecylindrical surface127 and theend surface128. Theend surface128 terminates at an inner flaredsurface131, thesurface131 defining an opening of thebore104. Upon assembly with thespacer12/liner13 combination, thecylindrical surface127 is in slidable relationship with the inner surface of theliner13 defining the through-bore92. As stated above, a desirable material for both theliner13 and thetubular extension100 is cobalt chromium. Furthermore, in some embodiments of the invention, in order to have low or no wear debris, theliner13 inner surface and theouter surface127 of thetubular extension100 may be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments. It is further noted that inner surfaces of thesleeves5 and7 that receive thecord22 may also be likewise coated to provide a slick, low to no wear debris interface with thecord22.
• With particular reference to FIGS.4 and23-26, thebumper16 is substantially cylindrical and tubular in form, having an outercylindrical surface140 and an inner, graduated through bore, generally142. Thebumper16 has opposed substantially planar annular end surfaces144 and146. Thebore142 is defined in part by a first innercylindrical surface148 that begins at thesurface146. Thesurface148 closely receives a tubular extension of thecord blocker18 as will be described in greater detail below. Adjacent theend144, thebumper16 includes a flared or beveled openingsurface150 extending to an innercylindrical surface152 having an inner diameter smaller than a diameter of the innercylindrical surface148. Acurved transition surface156 spans between thecylindrical surfaces152 and148. A substantial portion of thesurface156 is disposed perpendicular to thecylindrical surfaces152 and148. Thebumper16 is elastic and may be made from a variety of compressible and stretchable materials, including, but not limited to natural or synthetic elastomers such as polyisoprene (natural rubber), and synthetic polymers, copolymers, and thermoplastic elastomers, for example, polyurethane elastomers such as polycarbonate-urethane elastomers. In order to have low or no wear debris, thebumper16 inner surface may also be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments.
• With particular reference toFIGS. 27-30, thecord blocker18 and cooperating setscrew19 are shown. Theblocker18 includes abody portion159 and atubular extension160 sized and shaped to be slidingly received in thebumper16 at the innercylindrical surface148. The illustratedbody portion159 andtubular extension160 are integral or otherwise fixed to one another. A throughbore164 extends through a lower portion of thebody portion159 and centrally through thetubular extension160. Thebore164 is sized and shaped to receive thecord22 and when assembled with a remainder of theassembly1 extends along the axis A. Thebody portion159 includes an outer side andlower surface166 that is substantially U-shaped in cross-section, however, thesurface166 may have a variety of outer geometries, including cylindrical or of other curved or polygonal cross-sections. Thesurface166 terminates at an upperplanar surface168. Formed in thesurface168 is a threadedbore170 sized and shaped to receive and threadably mate with theset screw19. The threaded bore170 communicates with the throughbore164 and is substantially perpendicular thereto. Near the intersection of thebore164 and the threadedbore170, asurface172 partially defining thebore164 includes adepression174, sized and shaped for receiving thecord22 therein when theset screw19 engages thecord22 as will be described in greater detail below. Theblocker18 further includes opposed substantially planar end surfaces176 and178. Theend surface176 is also the end surface of thetubular extension160 that has an outercylindrical surface180. Theend surface178 is also the end surface of thebody159. The body further includes a substantially annularplanar end surface182 adjacent thetubular extension160. In operation, theend surface146 of thebumper16 abuts against theend surface182.
• Theset screw19 includes a threadedbody184 having a concave or domedbottom surface186 and a substantiallycylindrical head188. Formed in thecylindrical head188 is aninner drive189 sized and shaped to receive a driving tool for rotating and advancing theset screw19 into theblocker18 at the threadedbore170. Specifically, the threadedbody184 mates under rotation with the threadedbore170. Theset screw19 andblocker18 are sized and shaped to have a limited travel or stop such that when theset screw19 is rotated into thebore170 and extends into thebore164, theset screw19 locks and cannot be advanced any further at a desired location wherein thecord22 is frictionally held firmly and snugly in place between thedomed bottom186 and the concave ordepressed surface174 without damaging or destroying thecord22.
• With reference toFIG. 31a, it is noted that theblocker18 and setscrew19 combination is typically provided with thebumper16 pre-attached thereto and handled as a unit assembly. Thus, prior to being received by the surgeon, thebumper16 is wedged and in some cases adhered or otherwise fixed onto thetubular extension160 at the factory, with thesurface148 of the bumper frictionally engaging thesurface180 of theblocker18 and thesurface146 of thebumper16 abutting against and fixed to thesurface182 of theblocker18.
• With particular reference toFIG. 4, the illustratedcord22 includes anelongate body190 with anenlarged end192 and an opposed cut-to-length end194. Theenlarged end192 may be created by heating thecord22 to melt the cord and create theenlarged end192 that abuts against thesurface52 of thesleeve5 and is too large to enter thebore34. Alternatively an outer pin or knob (not shown) may be fixed to thecord22. In other embodiments of the invention a blocker and set screw combination, similar to theblocker18 and setscrew19 may be used to fix thecord22 outside of thesleeve5 and thus allow thecord22 to be in slidable relationship with thesleeve5. Thecord22 may be made from a variety of materials, including polyester or other plastic fibers, strands or threads, such as polyethylene-terephthalate. A cord according to the invention typically does not illustrate elastic properties, such as any significant additional axial distraction and lengthening after theassembly1 is operatively assembled and the cord is tensioned. However, it is foreseen that in some embodiments, thecord22 may be made of an elastic or semi-elastic material, such as a plastic or rubber (natural or synthetic) having at least some elastic properties, allowing for some further distraction of theassembly1 during operation thereof.
• With particular reference toFIGS. 31-37 thereference number25 generally represents a polyaxial bone screw apparatus or assembly in accordance with the present invention operably utilized by implantation into a vertebra (not shown) and in conjunction with the connectingmember assembly1 of the invention. Thebone anchor assembly25 generally includes ashank206, areceiver207, a retainer structure orring208, alower pressure insert209 and a closure structure or top210.
• Theshank206 is elongate and has anupper body portion214 integral with alower body portion215, ending in atip216. Theshank body215 has a helically wound boneimplantable thread217 extending from near thetip216 to near the top218 of thelower body215 and extending radially outward therefrom. During use, thebody215 utilizing thethread217 is implanted into a vertebra. Theshank206 has an elongated axis of rotation generally identified by the reference letter A′.
• Axially extending outward and upward from theshank body215 is aneck220, typically of reduced radius as compared to theadjacent top218 of thebody215. Further extending axially and outwardly from theneck220 is the shankupper portion214 operably providing a connective or capture structure free from the bone or vertebra for joining with thereceiver207. The shank upper portion or capturestructure214 has a radially outercylindrical surface222. Thecylindrical surface222 has at least one non-helically wound and radially outward extending projection orspline224 that extends beyond thesurface222. In the embodiment shown, the shankupper portion214 has threesuch splines224. It is noted that bone anchors of the invention have at least one and up to a plurality ofsplines224. Preferably, the bone anchor includes from one to four splines. Thesplines224 are located near and extend outwardly from anupper edge225 of the shank upper portioncylindrical surface222 and are equally circumferentially centered and spaced thereabout so as to be centered at approximately 120 degree intervals relative to each other. Each of thesplines224 has a substantially triangular shaped profile and a front wedge forming face227 that slopes downwardly and radially inwardly from near theupper edge225. Adjacent theupper edge225 is a centrally located, axially extending and upwardly directed convex annular projection or dome-shapedupper end229 that is centrally radiused. Each of thesplines224 includes anupper surface230 that is adjacent to and extends from theupper end surface229, having the same radius as theupper end surface229. Also formed in the shankupper portion214 within an annular rim228 of theend surface229 is atool engagement aperture231 for engagement by a tool driving head (not shown) that is sized and shaped to fit into the aperture for both driving and rotating theshank206 into a vertebra. In the illustrated embodiment, theaperture231 is star-shaped and runs parallel to the axis A′. It is foreseen that various sizes, shapes and numbers of apertures, slots or the like may be utilized in accordance with the invention for engaging a driving tool of suitable and similar mating shape. The illustratedshank206 is cannulated, having a through bore extending an entire length of theshank206 along the axis A′. The bore is defined by an inner cylindrical wall of theshank206 and has a circular opening at theshank tip206 and an upper opening communicating with theinternal drive feature231. The bore provides a passage through theshank206 interior for a length of wire (not shown) inserted into the vertebra (not shown) prior to the insertion of theshank body215, the wire providing a guide for insertion of theshank body215 into the vertebra (not shown).
• To provide a biologically active interface with the bone, the threadedshank body215 may be coated, cannulated, perforated, made porous or otherwise treated. The treatment may include, but is not limited to a plasma spray coating or other type of coating of a metal or, for example, a calcium phosphate; or a roughening, perforation or indentation in the shank surface, such as by sputtering, sand blasting or acid etching, that allows for bony ingrowth or ongrowth. Certain metal coatings act as a scaffold for bone ingrowth. Bio-ceramic calcium phosphate coatings include, but are not limited to: alpha-tri-calcium phosphate and beta-tri-calcium phosphate (Ca₃(PO₄)₂, tetra-calcium phosphate (Ca₄P₂O₉), amorphous calcium phosphate and hydroxyapatite (Ca₁₀(PO₄)₆(OH)₂). Coating with hydroxyapatite, for example, is desirable as hydroxyapatite is chemically similar to bone with respect to mineral content and has been identified as being bioactive and thus not only supportive of bone ingrowth, but actively taking part in bone bonding.
• Thereceiver207 has a generally squared-off U-shaped appearance with a partially cylindrical inner profile and a substantially faceted outer profile; however, the outer profile could also include other geometrical configurations. Side surfaces of thereceiver207 that engage thespacer12 and/or thebumper16 are preferably planar. A receiver axis of rotation B′ is aligned with the axis of rotation A′ of theshank206 during assembly of thereceiver207 with theshank206 and theretainer208. After thereceiver207 is pivotally connected to theshank206, and such assembly is implanted in a vertebra (not shown), the axis B′ is typically disposed at an angle with respect to the axis A′ of theshank206.
• Thereceiver207 has a base233 with a pair ofupstanding arms234 and235 forming aU-shaped channel238 between thearms234 and235 having alower seat239. Opposed planar side surfaces236 and237 define thechannel238 and extend upwardly from thebase233 and totop surfaces240 of the arms. Theinsert209 that is disposed within thereceiver207 is sized and shaped to closely receive thesleeve5 or thesleeve7 at the respectiveU-shaped surfaces36 and106. When assembled, thesleeve arms40 and42 and110 and112 lie flush with the side surfaces236 and237, advantageously providing a full support for thespacer12 and/or thebumper16 at abutting ends thereof. Each of thearms234 and235 has aninterior surface241 that includes a partial helically wound guide andadvancement structure242. In the illustrated embodiment, the guide andadvancement structure242 is a partial helically wound flangeform that mates under rotation with a similar structure on theclosure top210, as described below. However, it is foreseen that the guide andadvancement structure242 could alternatively be a buttress thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structures for operably guiding under rotation and advancing the closure top between thearms234 and235. Also, non-helically wound closure tops or caps are foreseen.Tool engaging apertures244 are formed on the outsides of thearms234 and235 for holding thereceiver207 during certain assembly steps and/or implantation of the assembly and also for access to a thindeformable wall245 during assembly with thepressure insert209.
• A chamber orcavity247 is located within thereceiver base233 that opens upwardly into theU-shaped channel238. Thecavity247 includes a partial spherical shapedsurface248, at least a portion of which forms a partial internal hemispherical seat for theretainer208, as is described further below. Alower neck250 defining a lower bore further communicates between thecavity247 and the bottom exterior of thebase233 and is coaxial with the rotational axis B′ of thereceiver207. Theneck250 at least partially defines a restriction having a radius which is smaller than the radius of theretainer208, so as to form a restrictive constriction at the location of theneck250 relative to theretainer208 to prevent theretainer208 from passing between thecavity247 and the lower exterior of thereceiver207. In an upper portion of thecavity247, is a substantiallycylindrical surface252 that includes a run-out surface253 located directly beneath the guide andadvancement structure242. With particular reference toFIGS. 33-36, formed in thesurface253 under thestructure242 of both of thearms234 and235 is arecess254 partially defined by a stop orabutment wall255. As will be described in greater detail below, the cooperatingcompression insert209 includes a protrudingstructure294 on each arm thereof that abuts against therespective wall255 of each of the receiver arms, providing a centering stop when theinsert209 is rotated into place as will be described below.
• Theretainer208 is substantially ring-shaped and has an operational central axis which is the same as the elongate axis A′ associated with theshank206, but when theretainer208 is separated from theshank206, the axis of rotation is identified as axis C′. Theretainer208 has acentral bore257 that passes entirely through theretainer208 from atop surface258 to abottom surface259 thereof. Thebore257 is sized and shaped to fit snugly, but slidably over the shank capture structurecylindrical surface222 in such a manner as to allow sliding axial movement therebetween under certain conditions, as described below. Three axially alignedchannels260 are spaced from the axis C′ and extend radially outward from thebore257 and into the wall of theretainer208 so as to form three top to bottom grooves or slots therein. Backs of thechannels260 are the same radial distance from the axis C′ as the distance the outermost portion of thesplines224 extend from the axis A′ of theshank206. Thechannels260 are also circumferentially angularly spaced equivalent to and have a width that corresponds with thesplines224. In this manner, the shankupper portion214 can be uploaded into theretainer208 by axially sliding the shankupper portion214 through theretainer208central bore257 whenever thesplines224 are aligned with thechannels260 or are in an aligned configuration. The details of assembly and subsequent cooperation between theshank206, theretainer208 and thereceiver207 are similarly described in Applicant's U.S. Pat. No. 6,716,214 issued Apr. 6, 2004, the entire disclosure of which is incorporated by reference herein.
• Theretainer208 also has three capture partial slots, receivers or recesses262 which extend radially outward from the upper part of thebore257 and that do not extend the entire length from top to bottom of theretainer208, but rather only open on thetop surface258 and extend partly along the height of theretainer208 thereof. Therecesses262 are sized and positioned and shaped to receive thesplines224 from above when thesplines224 are in a non-aligned configuration relative to thechannels260. That is, each of therecesses262 has a width that approximates the width of thesplines224 and has a matingwedge engaging surface264 that is shaped similar to the spline wedge forming faces227, so that thesplines224 can be slidably received into therecesses262 from above by axially translating or moving theshank206 downward relative to theretainer ring208 when thesplines224 are positioned above therecesses262 in a recess aligned configuration. In some embodiments, the wedge engaging faces264 slope slightly greater than the wedge forming faces227 on thesplines224 so that there is additional outward wedging that takes place when thesplines224 are urged downwardly into therecesses262.
• In this manner the shankupper portion214 can be uploaded or pushed upwardly through the retainercentral bore257 so as to clear the top258 of theretainer ring208, rotated approximately 60 degrees and then downloaded or brought downwardly so that thesplines224 become located and captured in therecesses262. Once thesplines224 are seated in therecesses262 theshank206 cannot move further axially downward relative to theretainer ring208. Preferably, theretainer208 is constructed of a metal or other material having sufficient resilience and elasticity as to allow theretainer208 to radially expand slightly outward by downward pressure of thesplines224 on therecesses262 under pressure from structure above, as will be discussed further below. This produces a slight outward radial expansion in theretainer ring208 at the location of therecesses262.
• Theretainer208 has a radially outer partial hemispherical shapedsurface265 sized and shaped to mate with the partial spherical shapedsurface248 and having a radius approximately equal to a radius associated with thesurface248. Theretainer208 radius is substantially larger than the radius associated with the annularcurved surface229 of the shankupper portion214 and also substantially larger than the radius of thereceiver neck250.
• The lower compression orpressure insert209 includes a substantiallycylindrical body270 integral with a pair ofupstanding arms272. Thebody270 andarms272 form a generally U-shaped, open, through-channel274 having alower seat276 sized and shaped to closely, snugly engage thesleeve5 or thesleeve7. Thearms272 disposed on either side of thechannel274 extend outwardly from thebody270. Thearms272 are sized and configured for placement near the run-out253 below the guide andadvancement structure242 at the receiverinner arms234 and235. Each of thearms272 includes atop surface278 ultimately located directly beneath the guide andadvancement structure242, but are not directly engaged by theclosure top210. However, in some embodiments of the bone screw for use with other longitudinal connecting members, the closure top may directly engage thetop surfaces278 for locking the polyaxial mechanism of theassembly25. Therefore, theassembly1 may be used with a wide variety of longitudinal connecting members, including thesleeves5 and7 or rods or other connecting members that engage theclosure top210 and are locked into position bysuch closure top210 as well as rods of smaller diameter or, for example cords that are captured by theclosure top210, but are otherwise movable within thereceiver207 and are thus in slidable or spaced relation with theclosure top210. Eacharm272 further includes a partially cylindricalouter surface280 sized and shaped to fit within thereceiver207 at the guide andadvancement structure242 run-out relief253. Thecylindrical surfaces280 are disposed substantially perpendicular to the respective adjacent top surfaces278. In some embodiments of the invention recesses are formed near and/or at thetop surfaces278 and the surfaces that form thechannel274 to provide relief for material flow of the longitudinal connecting member, when, for example, the connector is made from a deformable plastic. For example, a recessed surface or groove may be directed downwardly and inwardly toward thechannel274. Each of theouter surfaces280 further includes arecess282 sized and shaped to receive holding tabs or crimped material from thereceiver207. For example, thethin walls245 of thereceiver207 are pressed into therecesses282 to prevent counter-clockwise rotation of theinsert209 about the axis B′ with respect to thereceiver207. In other embodiments of the invention, thereceiver207 may be equipped with spring tabs that snap into therecesses282 to hold theinsert209 in place with respect to counter-clockwise rotation. Therecesses282 are preferably oval or elongate such that some desirable upward and downward movement of theinsert209 along the axis B′ of thereceiver207 is not prohibited. As previously described herein thecompression insert209 arms each include the protrudingstructure294 located on opposite sides of the arms such that when theinsert209 is dropped down into thereceiver207 as shown by the arrow M inFIG. 35 and then rotated into place in a clockwise direction as shown by the arrow N inFIG. 36, thestructure294 abuts thewall255 of the recessedarea254 when the insert is in a desired centered location with theapertures282 in alignment with theapertures244.
• Thecompression insert209 further includes an innercylindrical surface284 that forms a through bore sized and shaped to receive a driving tool (not shown) therethrough that engages theshank drive feature231 when theshank body215 is driven into bone. Theinner surface284 runs between theseating surface276 and an inner curved, annular, radiused orsemi-spherical surface286. Thesurface286 is sized and shaped to slidingly and pivotally mate with and ultimately fix against the annulardomed surface229 of the shankupper portion214. Thus, a radius of thesurface286 is the same or substantially similar to the radius of thesurface229. Thesurface286 may include a roughening or surface finish to aid in frictional contact between thesurface286 and thesurface229, once a desired angle of articulation of theshank206 with respect to thereceiver207 is reached. Adjacent to theinner surface286 is a bottom rim or edge288. Adjacent to the outercylindrical surface280 of thearms272 is a substantially frusto-conical surface290 that extends inwardly toward thelower rim88. The surface290 includes portions of thearms272 as well as partially defining thepressure insert body270.
• Thepressure inset body270 located between thearms272 has an outer diameter slightly smaller than a diameter between crests of the guide andadvancement structure242 of thereceiver207 allowing for top loading of thecompression insert209 into thereceiver207 through theU-shaped channel238, with thearms272 being located between thearms234 and235 during insertion of theinsert209 into the receiver207 (seeFIG. 35). As explained above, once located between the guide andadvancement structure242 and the shankupper portion214, theinsert209 is rotated into place about the axis B′ until thearms272 are directly below the guide andadvancement structure242 at or near the run-out253 and thestructure294 abuts against thewall255 of therecess254. After theinsert209 is rotated into such position, a tool (not shown) may be inserted into thereceiver apertures244 to press thethin receiver walls245 into the insert recesses282. Thelower compression insert209 is sized such that theinsert209 is ultimately received within thecylindrical surface252 of thereceiver207 below the guide andadvancement structure242. Thereceiver207 fully receives thelower compression insert209 and blocks thestructure209 from spreading or splaying in any direction. It is noted that assembly of theshank206 with theretainer208 within thereceiver207, followed by insertion of thelower compression insert209 into thereceiver207 are assembly steps typically performed at the factory, advantageously providing a surgeon with a polyaxial bone screw with thelower insert209 already held in alignment with thereceiver207 and thus ready for insertion into a vertebra.
• The compression or pressure insert209 ultimately seats on the shankupper portion214 and is disposed substantially in the uppercylindrical portion252 of thecavity247, with the receiverdeformable walls245 engaging theinsert209 at therecesses282, thereby cooperating with thewalls255 of therecesses254 to hold theinsert207 in desired alignment.
• The closure structure or closure top210 can be any of a variety of different types of closure structures for use in conjunction with the present invention with suitable mating structure on theupstanding arms234 and235. In the embodiment shown, theclosure top210 is rotatably received between the spacedarms234 and235 of thereceiver207. The illustratedclosure structure210 is substantially cylindrical and includes an outer helically wound guide andadvancement structure295 in the form of a flange form that operably joins with the guide andadvancement structure242 of thereceiver207. The flange form utilized in accordance with the present invention may take a variety of forms, including those described in Applicant's U.S. Pat. No. 6,726,689, which is incorporated herein by reference. It is also foreseen that according to the invention the closure structure guide and advancement structure could alternatively be a buttress thread, a square thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structure for operably guiding under rotation and advancing theclosure structure210 downward between thearms234 and235 and having such a nature as to resist splaying of thearms234 and235 when theclosure structure210 is advanced into thechannel238. The illustratedclosure structure210 also includes atop surface296 with aninternal drive297 in the form of an aperture that is illustrated as a star-shaped internal drive, but may be, for example, a hex-shaped drive or other internal drives, including, but not limited to slotted, tri-wing, spanner, two or more apertures of various shapes, and the like. A driving tool (not shown) sized and shaped for engagement with theinternal drive297 is used for both rotatable engagement and, if needed, disengagement of theclosure210 from thereceiver arms234 and235. It is also foreseen that theclosure structure210 may alternatively include a break-off head designed to allow such a head to break from a base of the closure at a preselected torque, for example, 70 to 140 inch pounds. Such a closure structure would also include a base having an internal drive to be used for closure removal. Abottom surface298 of theclosure top210 is planar and is sized and shaped to mate with thesleeve5 or thesleeve7 at respectiveplanar surfaces38 and108.
• Theclosure top210 may further include a cannulation through bore extending along a central axis thereof and through a surface of thedrive297 and thebottom surface298. Such a through bore provides a passage through theclosure210 interior for a length of wire (not shown) inserted therein to provide a guide for insertion of the closure top into thereceiver arms234 and235.
• When the polyaxial bone screw assembly201 is placed in use in accordance with the invention theretainer208 is normally first slid through the receiverU-shaped channel238 and into and seated in thereceiver cavity247. Thereafter, theretainer208 is rotated 90 degrees so as to be coaxial with thereceiver207 and so that the retainerouter surface265 snugly, but slidably mates with the receiver interior spherical shapedsurface248. Theretainer208 in thereceiver207 is then slid over the shankupper portion214 so that thesplines224 slide upwardly through and aboverespective channels260 so that thesplines224 are then located, at least partially, in theU-shaped channel238 andchamber247 above theretainer ring208. Theshank206 is then rotated 60 degrees relative to the receiver about the axis A′ and the translational direction of theshank206 is reversed so that it goes downwardly or axially with respect to thereceiver207, and thesplines224 enter therecesses262. At this point there is no substantial outward or downward pressure on theretainer208 and so theretainer208 is easily rotatable along with theshank206 within thechamber247 and such rotation is of a ball and socket type wherein the angle of rotation is only restricted by engagement of theneck220 with theneck250 of thereceiver207.
• Then, theinsert209 is inserted into thechannel238 with thearms272 aligned in thechannel238 between the guide andadvancement structures242. Theinsert209 is then moved downwardly in thechannel238 and toward thecavity247. With reference toFIGS. 35-36, once thearms272 are located generally below the guide andadvancement structure242 and adjacent the run-out relief253, theinsert209 is rotated 90 degrees in a clockwise direction about the axis B′ of thereceiver207. Thearms272 fit within thecylindrical walls252 above thecavity247. Once thestructures294 abut against thewalls255, thearms272 are desirably located directly below the guide andadvancement structures242, rotation is ceased and a tool (not shown) is used to press thethin walls245 of thereceiver207 into therecesses282 of theinsert209. Theinsert209 is now locked into place inside thereceiver207 with the guide andadvancement structures242 prohibiting upward movement of the insert out of thechannel238.
• As illustrated inFIGS. 32 and 37, theinsert209 seats on the shankupper portion214 with thesurface286 in sliding engagement with thesurface229. The run-out orrelief253 is sized and shaped to allow for some upward and downward movement of theinsert209 toward and away from the shankupper portion214 such that theshank206 is freely pivotable with respect to thereceiver207 until theclosure structure210 presses on thesleeve5 or thesleeve7 that in turn presses on theinsert209 that in turn presses upon theupper portion214 into locking frictional engagement with thereceiver207 at thesurface248.
• The resulting assembly is then normally screwed into a bone, such as vertebra, by rotation of theshank206 using a suitable driving tool (not shown) that operably drives and rotates theshank206 by engagement thereof at theinternal drive231. Normally, thereceiver207,retainer208 and insert209 are assembled on theshank206 before placing theshank206 in the vertebra, but in certain circumstances, theshank206 can be first implanted with thecapture structure214 extending proud to allow assembly and then theshank206 can be further driven into the vertebra.
• Theassembly1 may be assembled as follows: First, after the twobone screws25 are implanted, the distance between the screws is measured. Thereafter, the spacer/liner combination10 is cut to a desired length based upon the measurement made between the bone screws. As described above, thespacer12 and theliner13 that form the spacer/liner combination10 are typically assembled at the factory, with theliner13 being fixed to thespacer12 along the spacer innercylindrical surface72. The spacer/liner combination10 is cut at the spacer end76 (that is also the liner end96) that is opposite the graduated end of thespacer12. A tool (not shown), similar to a pipe cutter is usually used to rotate and cut the spacer/liner combination10 to the desired length. Also at this time, in view of the resulting spacer/liner10 length, asleeve7 of a desired size is chosen. Because thesleeve7 is made from a hard material, typically a metal or metal alloy, it is not practical to cut thetube portion100 of thesleeve7 to a desired length during the surgical procedure. Therefore, a variety ofsleeves7 are typically provided to end users having at least threedifferent tube portion100 lengths.
• With particular reference toFIG. 4, thesleeve5 is then slid onto thecord22 at thecord end194, with theend194 being inserted into the throughbore34 at thesleeve end52 and out thesleeve end64. Thesleeve5 is then fed along thecord22 until thesleeve end52 is adjacent theenlarged cord end192. It is noted that thecord22 is typically much longer than shown in the drawing figures and then cut to length near theend194 after being fully assembled with the remaining elements of theassembly1, tensioned and fixed to theblocker18. After thesleeve5 is in place on thecord22, the spacer/liner combination10 (or optionally, the spacer without a liner) is loaded with thecord end194 being inserted into the flaredopening80 at theend74, the innercylindrical surface82, the innercylindrical surface84 and thereafter, the liner bore92 and out theliner end96 andspacer end76. The spacer/liner combination10 is slid along thecord22 until theend74 contacts thetubular extension32 of thesleeve5. A tensioning device (not shown) is typically needed to push and/or pull thespacer12 against and over portions of thetubular extension32 of thesleeve5 until the innercylindrical surface82 of thespacer12 fully engages the outercylindrical surface56 of thetubular extension32 and the innercylindrical surface84 of thespacer12 fully engages the outercylindrical surface60 of thetubular extension32. At this time thesleeve end64 is abutting against thespacer end surface74 and in fixed relation thereto. However, both the spacer/liner combination10 and the now attachedsleeve5 are in sliding relationship with thecord22. It may be necessary to warm thespacer12 prior to assembly with thetubular extension32 to allow for stretching and expansion of thespacer12 graduated inner surface (surfaces80,82,84, and86) to fit about the knob defined by the tubular extensionannular wall58 andcylindrical surface60. Thesleeve7 is then loaded with thecord end194 being inserted into the throughbore104 at theopening surface131 near theend128 and out theopening125 at theend surface124. Thesleeve7 is then slid along thecord22 with thetubular extension100 sliding into the liner bore92. Thereafter, theblocker18 withpre-attached bumper16 and loosely mated set screw19 (as shown inFIG. 30a) is loaded onto thecord22 with thecord end194 being inserted into the bumper bore152 at theopening150 located near thebumper end144 and exiting the blocker bore opening near theend surface178. Thebumper16 and attachedblocker18 are slid along thecord22 until thebumper end144 abuts against thesleeve7end surface124. The resulting assembly, similar to what is shown inFIGS. 2 and 3 is now ready for placement in and between the implanted bone screws25, with theset screw19 engaged with thecord22 enough to prevent the elements from slipping off of thecord22. Unlike the illustrations ofFIGS. 2 and 3, thecord22 is not yet tensioned and thus the individual elements would most likely be more spread apart along the cord more than is illustrated in the drawings figures. Also, thecord22 is much longer at this time so that the cord may be grasped and tensioned after the assembly is fixed to the bone screws25.
• Theassembly1 is implanted by inserting thesleeve5 in to one of the bone screws25 and thesleeve7 into another of the bone screws25. Closure tops210 are then inserted into and advanced between thearms234 and235 of each of thereceivers207 so as to bias or push against thesleeve5 and thesleeve7 at respectiveplanar surfaces38 and108. A driving tool (not shown) is inserted into each drive297 to rotate and drive the respective closure top210 into thereceiver207. Eachshank dome229 is engaged by the cooperatinginsert209 and pushed downwardly when theclosure top210 pushes downwardly on thesleeve5 orsleeve7. The downward pressure on theshank206 in turn urges thesplines224 downwardly which exerts both a downward and outward thrust on theretainer ring208. Two polyaxial bone screws25, including the dynamic connectingmember assembly1, are shown inFIGS. 1 and 37, illustratingvarious shank206 toreceiver207 angular configurations.
• A tensioning tool (not shown) known in the art is then used to pull upon and put tension on thecord22 near theend194. Thecord22 is preferably tensioned until the bumper compresses as shown inFIGS. 1 and 37 and then theset screw19 is rotated and driven into theblocker18 and up against thecord22 using a driving tool (not shown) engaged with theinner drive189. Theblocker18 advantageously includes opposed planar sides allowing for the placement of a counter-torque tool for holding theblocker18 during tensioning and fixing of thecord22 within the blocker. As explained above, theset screw19 andblocker18 combination include a limited travel feature such that theset screw19 is locked into place at a location that firmly holds but does not damage thecord22. Thecord22 is then trimmed to a desired length near theblocker end178.
• Theassembly1 is thus substantially dynamically loaded and oriented relative to the cooperating vertebra, providing relief (e.g., shock absorption) and protected movement with respect to flexion, extension, distraction and compressive forces placed on theassembly1 and the two connected bone screws25. The outer surfaces of the arms of thesleeves5 and7, in particular thesurface52 of thesleeve5 and thesurfaces122 and124 of thesleeve7 are in fixed, flush relationship with theplanar side surface236 or237 of an engagedbone screw receiver207, thus better supporting compression between the spacer12 or thebumper16 during flexion and extension than that provided by current open implants that are not equipped withflush sleeves5 or7. It is also noted that a problem encountered with dynamic spinal implant systems is the need to provide adequate support with respect to bending sheer. Most spinal movements are not purely bending movements, e.g., flexion and extension. Most movements include both bending and tension, extension or compression. Such bending shear is not well resisted by a cord and spacer alone that performs well in tension, but not when the tension includes a vector force. The present invention advantageously provides a hard,non-elastic extension100 of a rigid slidingsleeve body99, theextension100 further located within anon-elastic liner13 of thespacer12. Such features protect against vector forces while still allowing for advantageous tension of thecord22 as well as improved compression provided by theouter bumper16. Thecord22 and thesleeve7 allow for some twisting or turning, providing some relief for torsional stresses. Furthermore, thecompressed bumper16 and the fixed contact between the sleeve4 and thespacer12 as well as the fixed contact between thebumper16 and theblocker18 places some limits on torsional movement as well as bending movement, to provide spinal support. The cord22 (in tension) and bumper16 (in compression) allow for compression and some extension of theassembly1 located between the twobone screws25, e.g., shock absorption. Another advantage of embodiments of the present invention is that because of the inelastic sleeve extension that slides within the typically elastic spacer located between two bone screws, the resultingassembly1 is more stable than a cord and spacer alone, therefore strength of the assembly does not rely upon the amount of tension placed upon the cord. Therefore, in embodiments according to the invention, it is not necessary to place as much tension on thecord22 as would be required for a more traditional cord and spacer arrangement, thus protecting the cord from damage of over stressing.
• It is also noted that in other embodiments of a connectingmember1 according to the invention, thesleeve5 may be extended at theend52 to provide a hard, non-elastic elongate portion for attachment to an additional bone screw or screws, if needed, to provide a connecting member with both dynamic, elastic segments as well as a longer rigid inelastic segment.
• If removal of theassembly1 from any of thebone screw assemblies25 is necessary, or if it is desired to release theassembly1 at a particular location, disassembly is accomplished by using the driving tool (not shown) with a driving formation cooperating with theclosure structure210internal drive297 to rotate and remove theclosure structure210 from thereceiver207. Disassembly is then accomplished in reverse order to the procedure described previously herein for assembly.
• Eventually, if the spine requires more rigid support, the connectingmember assembly1 according to the invention may be removed and replaced with another longitudinal connecting member, such as a solid rod or bar, having the same width or diameter as body portions of thesleeves5 and7, utilizing thesame receivers207 and the same orsimilar closure structures210. Alternatively, if less support is eventually required, a less rigid, more flexible assembly, for example, anassembly1 having aspacer12 andbumper16 made of a softer more compressible material than the spacer and bumper being replaced thereby, also utilizing the same bone screws25.
• With reference toFIG. 1a, an alternative longitudinal connecting member assembly according to the invention, generally1a, for use with apolyaxial screw25 and a monoaxial or fixed screw,25ais shown. Thescrew25acooperates with a closure top210ato fix a tensionedcord22abetween thescrew25aand ablocker18 and cooperating setscrew19 of the invention previously described herein. The fixedscrew25aand cooperatingclosure210aare the same or similar to therespective screw12 and closure top14 shown and described in U.S. patent application Ser. No. 12/661,042, filed Mar. 10, 2010, the disclosure of which is incorporated by reference herein. In the illustrated embodiment, thepolyaxial screw25 engages thesleeve7 that allows thecord22ato slide with respect thereto, thecord22abeing tensioned between thescrew25aand theblocker18. Thespacer12 of the invention is compressible and directly engages themonoaxial screw25aat one end thereof and thepolyaxial screw25 at the other end thereof. Furthermore, thespacer12 engages thesleeve7 that is flush with thescrew25. Theblocker18 directly engages thesurface237 of thepolyaxial screw25. Although the use of abumper16 is preferred according to the invention, as shown inFIG. 1a, a bumper is not necessary in some embodiments. It is also foreseen that in some embodiments of the invention, thesleeves5 and7 may be sized to fit entirely within a cooperating bone anchor, such that, for example, the bumper and spacer may directly engage thesurfaces237 of thebone screw25, but not engage any surface of the sleeve that is fully contained within the bone screw receiver. In such embodiments, the sleeve may include a rim or nub (with cooperating structure on the receiver) for keeping such sleeve within the confines of the cooperating bone screw receiver. Such a nub or rim may also keep such a recessed sleeve in alignment with the receiver arms and in a position that an aperture in such a sleeve may receive a portion of a closure top for gripping a cord that is slidingly received within such a sleeve.
• With reference toFIGS. 38-43, an alternative longitudinal connecting member assembly according to the invention, generally301, for use with threebone screws25 includes afirst sleeve305, asecond sleeve307, a third sleeve308, a first spacer/liner combination310 and a second spacer/liner combination311. The first spacer/liner combination310 includes anouter spacer312 and aninner liner313 and the second spacer/liner combination311 includes anouter spacer314 and aninner liner315. The illustrated spacer/liner combination311 is identical to the spacer/liner combination310 with the exception of a length thereof along a central axis A″. Theassembly301 further includes abumper316, acord blocker318 and mating setscrew319 and acord322. Theassembly301 is substantially similar to theassembly1 with the exception of the addition of the third sleeve308 and the second spacer/liner combination311. Thus, thefirst sleeve305, thesecond sleeve307, the first spacer/liner combination310, thebumper316, thecord blocker318, theset screw319 and thecord322 are the same or substantially similar to the respectivefirst sleeve5,second sleeve7, spacer/liner combination10,bumper16,cord blocker18, setscrew19 andcord22 of theassembly1 previously discussed above and thus shall not be discussed further herein. Although only one additional sleeve309 (and attached bone screw25) and cooperating spacer/liner311 are illustrated in the drawings, it is noted that theassembly301 of the invention may be lengthened further and adapted for use with additional bone screws by simply addingmore sleeves309 and cooperating spacer/liners311 between thesleeve305 and thesleeve307.
• With particular reference toFIGS. 40-43, thesleeve309 includes abody portion330 generally sized and shaped for being received within thepolyaxial bone screw25 and a firsttubular extension332 sized and shaped to engage and hold thespacer312 in fixed engagement with thesleeve309. The sleeve also includes a second opposedtubular extension333 sized and shaped to be slidingly received by the spacer/liner combination311. The illustratedbody portion330 andtubular extensions332 and333 are integral or otherwise fixed to one another. A throughbore334 extends through a lower portion of thebody portion330 and centrally through both thetubular extensions332 and333. Thebore334 is sized and shaped to slidingly receive thecord322 and when assembled with a remainder of theassembly301 extends along the axis A″. Thebody portion330 includes an outer side andlower surface336 that is substantially U-shaped in cross-section, being sized and shaped to fit within a U-shaped opening of thebone screw25. A substantial portion of thesurface336 terminates at an upperplanar surface338, with the U-shaped surface extending on either side of theplanar surface338 into upwardly extending arms orflanges340 and342. An optional opening329 (shown in phantom) may be formed in theplanar surface338, theopening329 sized and shaped for receiving a portion of an alternative closure top (not shown) that is sized and shaped to extend through theopening329 and press against and/or penetrate the cord portion located within thesleeve309, locking the cord with respect to thesleeve309 as will be described in greater detail herein with respect to other embodiments of the invention (see, e.g.,FIGS. 44 and 116).Inner surfaces344 and346 of therespective arms340 and342 form a discontinuous cylindrical wall sized and shaped to receive a closure top of thebone screw25. Theplanar surface338 is also a seating surface for the bone screw closure top. Thearms340 and342 and theU-shaped body336 are sized and shaped to fit within the receiver of thebone screw25 and resist rotation and other forces placed on thesleeve309. However, it is noted that in some embodiments, thesleeve309 may be substantially cylindrical in outer form and thus receivable within a variety of fixed or polyaxial screw heads. In the illustrated embodiment, thearms340 and342 that are received within thepolyaxial screw25 terminate at respective upperplanar surfaces348 and350. Thearms340 and342 further include respective substantially planar outer or endsurfaces352 and354, such surfaces being operatively flush with the side surfaces236 or237 of thebone screw25. Theouter surface354 is adjacent to atapered surface355 that extends toward and terminates at a firstcylindrical surface356 of thetubular extension332. The outercylindrical surface356 terminates at a radially extending annular wall358 that is perpendicular thereto. The wall358 terminates at a second substantiallycylindrical surface360 of greater outer diameter than thecylindrical surface356. Thesurface360 terminates at an annular inwardly taperingbeveled surface362. Thebevel362 is adjacent to a planarannular end surface364 that is disposed perpendicular to thecylindrical surface360. Thesurface364 is adjacent to a flared orbeveled surface365 that defines an opening of thebore334. Thesurfaces356,358 and360 provide a push-on connective element for attachment to inner surfaces of thespacer312. Thesleeves305,307,309, theliners313 and315 and thecord blocker318 with setscrew319 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• Thetubular structure333 includes aend surface364 located adjacent to a flared orbeveled surface365 that defines an opposite opening thebore334. At an opposite end of thetubular structure333, the arm outerplanar surface352 is adjacent to atapered surface366 that extends toward and terminates at acylindrical surface367 of thetubular extension333. The outercylindrical surface367 extends toward an annularplanar end surface368 that is perpendicular thereto. Abeveled surface370 spans between thecylindrical surface367 and theend surface368. Theend surface368 terminates at an inner flaredsurface371, thesurface371 defining an opening of thebore334. Upon assembly with thespacer314/liner315 combination, thecylindrical surface367 is in slidable relationship with the inner surface of theliner315. A desirable material for both theliner315 and thetubular extension333 is cobalt chromium. Furthermore, in some embodiments of the invention, in order to have low or no wear debris, theliner315 inner surface and theouter surface367 of thetubular extension333 may be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments.
• As stated above, the spacer/liner combination311 is identical to the spacer/liner combination310 with the exception of length along the axis A″. Thus, the spacer/liner combination311 is identical or substantially similar to the spacer/liner combination10 previously described herein. With reference toFIG. 39, during assembly, thespacer312 is press-fitted over thetubular extension332 of thesleeve309 while thespacer314 is press fitted over the tubular extension of thesleeve305. Thus, the elements are loaded onto thecord322 as follows: thesleeve305, followed by the spacer/liner combination311, followed by thesleeve309, followed by the spacer/liner combination312 followed by thesleeve307, followed by thebumper316 and attachedblocker318 with setscrew319. Theassembly301 is implanted with each of thesleeves305,307 and309 being attached to abone screw25 as shown inFIG. 38. After the sleeves are attached to the bone screws25, thecord322 is tensioned. Thus, the fully assembled and dynamically loadedassembly301 allows for translation of the receivers or heads207 of all three of the bone screws25 along the tensionedcord322 while at the same time all threesleeves305,307 and309 are fixedly coupled to arespective screw receiver207. Furthermore, thetubular extension333 of thesleeve309 as well as the tubular extension of thesleeve307 glide within spacer/liner combinations310 and311, protecting the assembly from bending shear forces while allowing for the desired movement of all threescrews25 with respect to the tensionedcord322.
• With particular reference toFIGS. 45-95, thereference numeral1001 generally designates a non-fusion dynamic stabilization longitudinal connecting member assembly according to the present invention. The connectingmember assembly1001 is elongate, having a substantially central axis A. With particular reference toFIGS. 45-48, the illustrated connectingmember assembly1001 generally includes at least first and second hard, inelasticflanged sleeves1005 and1007 with a spacer/liner combination, generally1010, located therebetween. In particular, the spacer/liner combination1010 includes anouter spacer1012 and an inneroptional liner1013. Theassembly1001 further includes anelastic bumper1016, acord blocker1018 with cooperating setscrew1019 and an inner core that in the present embodiment is acord1022. Thecord1022 extends along the axis A and successively through and within thesleeve1005, thespacer1012, the sleeve1007 (and spacer/liner1010), thebumper1016 and thecord blocker1018 as shown, for example, inFIG. 72. InFIGS. 45 and 72, theassembly1001 is shown attached to two polyaxial bone screws, generally1025 at thesleeves1005 and1007. A portion of thesleeve1007 extends into and through the spacer/liner1010 and is in slidable relationship therewith. A portion of thecord blocker1018 extends into a bore of thebumper1016. As will be described and explained in greater detail below, thebumper1016 is typically made from an elastomer while theouter spacer1012 is also elastomeric, but typically made from a material with a different durometer, being tougher and less compressible than the material of thebumper1016. Furthermore, thesleeves1005 and1007 and thespacer liner1013 are made from a hard, non-elastic material, such as a metal or metal alloy, like cobalt chromium. The hard and stiff slidingsleeve1007 includes an extension that slides into theliner1013, providing a dynamic no- or low-wear, sliding relationship between thesleeve1007 and theliner1013 that is non-binding, and provides excellent shear resistance while at the same time, thethin liner1013 cooperating with theelastomeric spacer1012 as well as the tensionedcord1022 provide controlled bending, with the tensionedcord1022 and compressedbumper1016, performing well under tension and compression. Flanged portions of thesleeves1005 and1007 are located on either side of the bone screws1025, the flanges abutting against thespacer1012 or thebumper1016, the flanges extending radially outwardly to an extent to fully engage ends of thespacer1012 or thebumper1016, resulting in a stable, secure, substantially full contact between the individual elements of theassembly1001. Furthermore, the flanges allow for assembly and dynamic setting of the assembly prior to implantation, if desired, with thecord1022 being placed in tension and at least thebumper1016 being placed in compression. In some embodiments of the invention, tensioning of thecord1022 and compression of thebumper1016 and optionally thespacer1012 may be performed after theassembly1001 is attached to the bone screws1025.
• With particular reference toFIGS. 49-53, thesleeve1005 further includes abody portion1030 generally sized and shaped for being received within thepolyaxial bone screw1025 and atubular extension1032 sized and shaped to engage and hold thespacer1012 in fixed engagement with thesleeve1005. The illustratedbody portion1030 andtubular extension1032 are integral or otherwise fixed to one another. A throughbore1034 extends centrally through thebody portion1030 and centrally through thetubular extension1032. Thebore1034 is sized and shaped to slidingly receive thecord1022 and when assembled with a remainder of theassembly1001 extends along the axis A. Thebody portion1030 further includes a pair of spaced radially extendingflanges1036 and1037 with acylindrical body surface1038 being located therebetween. Theflanges1036 and1037 are spaced for closely receiving thebone screw1025 therebetween as will be described in greater detail below. Theflange1036 also defines an end of thesleeve1005 while theflange1037 is located at a juncture of thebody portion1030 and thetubular extension1032. Thecylindrical surface1038 is sized and shaped to be receivable within and frictionally fixed to a variety of monoaxial or polyaxial screw heads. In the illustrated embodiment, theflanges1036 and1037 further include respective substantially planarinner surfaces1042 and1043, respective outerplanar surfaces1046 and1047 and respective outercylindrical surfaces1048 and1049. Thesurfaces1046 and1047 may include ridges or other protruding structure for resisting rotation about the axis A. Theplanar surface1046 also defines an end surface of thesleeve1005. Thesurface1046 is adjacent to a flared orbeveled surface1053 that defines an opening of thebore1034. Theouter surface1047 is adjacent to atapered surface1055 that extends toward and terminates at a firstcylindrical surface1056 of thetubular extension1032. The outercylindrical surface1056 terminates at a radially extendingannular wall1058 that is substantially perpendicular thereto and may be curved or flat. Thewall1058 terminates at a second substantiallycylindrical surface1060 of greater outer diameter than thecylindrical surface1056. Thesurface1060 terminates at an annular inwardly taperingbeveled surface1062. Thebevel1062 is adjacent to a planarannular end surface1064 that is disposed perpendicular to thecylindrical surface1060. Thesurface1064 is adjacent to a flared orbeveled surface1065 that defines an opening of thebore1034. Thesurfaces1056,1058 and1060 provide a push-on connective element for attachment to inner surfaces of thespacer1012 as will be described in greater detail below. Thesleeve1005, as well as thesleeve1007, theoptional liner1013 and thecord blocker1018 withset screw1019 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• With particular reference toFIGS. 45-48 and54-57, thespacer1012 is substantially cylindrical and tubular in form, having an outercylindrical surface1070 and an inner, graduated through bore, generally1072. Thespacer1012 has opposed substantially planarannular end surfaces1074 and1076. Thebore1072 is defined in part by a first inner cylindrical surface1078 that begins at thesurface1076 and extends substantially along a length of thespacer1012. The surface1078 closely receives theinner liner1013 thereon. In fact, thespacer1012/liner1013 combination is typically assembled or manufactured with theoptional liner1013 being fixed to the surface1078 such that a surgeon receives thespacer1012/liner1013 combination already assembled and ready for the surgeon to cut thespacer1012/liner1013 combination to a desired length near theend1076 as will be described in greater detail below. Adjacent theend1074, thespacer1012 includes a flared orbeveled opening surface1080 extending to an innercylindrical surface1082 having an inner diameter smaller than the cylindrical surface1078. A third innercylindrical surface1084 is located between thesurface1082 and the surface1078, thesurface1084 having a diameter larger than thesurface1082 and smaller than the surface1078. Acurved transition surface1086 spans between thecylindrical surfaces1082 and1084 and acurved transition surface1088 spans between thecylindrical surfaces1084 and1078. Portions of the transition surfaces1086 and1088 are substantially perpendicular to thecylindrical surfaces1078,1082 and1084. As will be described in greater detail below, when thespacer1012/liner1013 combination (or in some embodiments, aspacer1012 only) is pushed onto thetubular extension1032 of thesleeve1005 during assembly, theend surface1074 of thespacer1012 engages theplanar surface1047 of thesleeve1005, the flaredsurface1080 of the spacer engages the taperedsurface1055 of the sleeve, the innercylindrical surface1082 engages the outercylindrical surface1056 of the sleeve, thesurface1086 of the spacer engages thesurface1058 of the sleeve, and the innercylindrical surface1084 of the spacer engages the outercylindrical surface1060 of thetubular extension1032. As best shown inFIG. 72, the close fit between the spacer innercylindrical surfaces1082 and1084 and thetubular extension1032 of thesleeve1005, provide a secure, fixed positioning of thespacer1012 with respect to thesleeve1005 along the axis A, prohibiting thespacer1012 from being pulled away from the sleeve surface1054 during spinal movement. However, some relative rotational movement between thespacer1012 and thesleeve1005 about the axis A is possible, allowing for some twist or turn, providing some relief for torsional stresses. Thespacer1012 is typically elastic and made from a plastic, for example, a thermoplastic elastomer made from a polyurethane or polyurethane blend, such as a polycarbonate urethane.
• Also with particular reference toFIGS. 54-57, the optionalinelastic liner1013 is substantially cylindrical and tubular in form, having an outercylindrical surface1090 and an inner cylindrical throughbore1092. Theliner1013 has opposedannular end surfaces1094 and1096. As best shown inFIG. 57, theend surface1094 abuts against theannular surface1088 of thespacer1012 and the outercylindrical surface1090 is adhered or otherwise fixed to the inner cylindrical surface1078 of thespacer1012. Theend surface1096 is disposed flush to theend surface1076 of thespacer1012, these surfaces being the cut-to-length side of thespacer1012/liner1013 combination as will be described in greater detail below. Although shown as a separate part or element in some of the drawings, when used, theoptional liner1013 is typically provided pre-assembled within thespacer1012. Theliner1013 may be made from a variety of non-elastic materials, including metals, metal alloys and some plastics, with cobalt chromium being a preferred material. The innercylindrical surface1092 is sized and shaped to slidingly receive a tubular extension of theinelastic sleeve1007 as will be described in greater detail below.
• With particular reference toFIGS. 58-61, thesleeve1007 includes abody portion1099 generally sized and shaped for being received within thepolyaxial bone screw1025 and atubular extension1100 sized and shaped to be slidingly received in thespacer1012/liner1013 combination. The illustratedbody portion1099 andtubular extension1100 are integral or otherwise fixed to one another. With particular reference toFIG. 95, more than one size ofsleeve1007 is typically provided to the surgeon, thesleeves1007 differing only in the length of thetubular extension1100, so as to appropriately match the size of the patient's spine. A throughbore1104 extends centrally through thebody portion1099 and thetubular extension1100. Thebore1104 is sized and shaped to slidingly receive thecord1022 and when assembled with a remainder of theassembly1001 extends along the axis A. Thebody portion1099 includes an outercylindrical surface1106 disposed between two radially extendingflanges1110 and1112. Thebody portion1099 andflanges1110 and1112 of thesleeve1007 are substantially similar in form and function to the respectivecylindrical body surface1038 andflanges1036 and1037 of thesleeve1005, with a polyaxial bone screw receiver being received between theflanges1110 and1112. Theflanges1110 and1112 further include respective substantially planarinner walls1114 and1116, outercylindrical surfaces1118 and1120 and outer walls orend surfaces1122 and1124. Thesurfaces1122 and1124 may include ridges or other protrusions. Theouter surface1124 is also an end surface of thesleeve1007. Thesurface1124 is adjacent to a flared orbeveled surface1125 that defines an opening of thebore1104. Theouter surface1122 is adjacent to atapered surface1126 that extends toward and terminates at acylindrical surface1127 of thetubular extension1100. The outercylindrical surface1127 extends toward an annularplanar end surface1128 that is perpendicular thereto. Abeveled surface1130 spans between thecylindrical surface1127 and theend surface1128. Theend surface1128 terminates at an inner flaredsurface1131, thesurface1131 defining an opening of thebore1104. Upon assembly with thespacer1012/liner1013 combination, thecylindrical surface1127 is in slidable relationship with the inner surface of theliner1013 defining the through-bore1092. As stated above, a desirable material for both theliner1013 and thetubular extension1100 is cobalt chromium. Furthermore, in some embodiments of the invention, in order to have low or no wear debris, theliner1013 inner surface and theouter surface1127 of thetubular extension1100 may be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments. It is further noted that inner surfaces of thesleeves1005 and1007 that receive thecord1022 may also be likewise coated to provide a slick, low to no wear debris interface with thecord1022.
• With particular reference toFIGS. 62-68, thebumper1016 is substantially cylindrical and tubular in form, having an outercylindrical surface1140 and an inner, graduated through bore, generally1142. Thebumper1016 has opposed substantially planarannular end surfaces1144 and1146. Thebore1142 is defined in part by a first innercylindrical surface1148 that begins at thesurface1146. Thesurface1148 closely receives a tubular extension of thecord blocker1018 as will be described in greater detail below. Adjacent theend1144, thebumper1016 may include a flared or beveled opening surface extending to an innercylindrical surface1152 having an inner diameter smaller than a diameter of the innercylindrical surface1148. Acurved transition surface1156 spans between thecylindrical surfaces1152 and1148. A substantial portion of thesurface1156 is disposed perpendicular to thecylindrical surfaces1152 and1148. Thebumper1016 is elastic and may be made from a variety of compressible and stretchable materials, including, but not limited to natural or synthetic elastomers such as polyisoprene (natural rubber), and synthetic polymers, copolymers, and thermoplastic elastomers, for example, polyurethane elastomers such as polycarbonate-urethane elastomers. In order to have low or no wear debris, thebumper1016 inner surface may also be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments.
• Also with reference toFIGS. 62-68, thecord blocker1018 and cooperatingset screw1019 are shown. Theblocker1018 includes abody portion1159 and atubular extension1160 sized and shaped to be slidingly received in thebumper1016 at the innercylindrical surface1148. The illustratedbody portion1159 andtubular extension1160 are integral or otherwise fixed to one another. A throughbore1164 extends through a lower portion of thebody portion1159 and centrally through thetubular extension1160. Thebore1164 is sized and shaped to receive thecord1022 and when assembled with a remainder of theassembly1001 extends along the axis A. Thebody portion1159 includes an outer side andlower surface1166 that is substantially U-shaped in cross-section, however, thesurface1166 may have a variety of outer geometries, including cylindrical or of other curved or polygonal cross-sections. Thesurface1166 terminates at an upper planar surface1168. Formed in the surface1168 is a threadedbore1170 sized and shaped to receive and threadably mate with theset screw1019. The threadedbore1170 communicates with the throughbore1164 and is substantially perpendicular thereto. Near the intersection of thebore164 and the threadedbore1170, a surface1172 partially defining thebore1164 includes a depression1174, sized and shaped for receiving thecord1022 therein when theset screw1019 engages thecord1022 as will be described in greater detail below. Theblocker1018 further includes opposed substantiallyplanar end surfaces1176 and1178. Theend surface1176 is also the end surface of thetubular extension1160 that has an outercylindrical surface1180. Theend surface1178 is also the end surface of thebody1159. The body further includes a substantially annularplanar end surface1182 adjacent thetubular extension1160. In operation, theend surface1146 of thebumper1016 abuts against theend surface1182.
• Theset screw1019 includes a threadedbody1184 having a concave ordomed bottom surface1186 and a substantiallycylindrical head1188. Formed in thecylindrical head1188 is aninner drive1189 sized and shaped to receive a driving tool for rotating and advancing theset screw1019 into theblocker1018 at the threadedbore1170. Specifically, the threadedbody1184 mates under rotation with the threadedbore1170. Theset screw1019 andblocker1018 are sized and shaped to have a limited travel or stop such that when theset screw1019 is rotated into thebore1170 and extends into thebore1164, theset screw1019 locks and cannot be advanced any further at a desired location wherein thecord1022 is frictionally held firmly and snugly in place between thedomed bottom1186 and the concave or depressed surface1174 without damaging or destroying thecord1022.
• It is noted that theblocker1018 and setscrew1019 combination is typically provided with thebumper1016 pre-attached thereto and handled as a unit assembly. Thus, prior to being received by the surgeon, thebumper1016 is wedged and in some cases adhered or otherwise fixed onto thetubular extension1160 at the factory, with thesurface1148 of the bumper frictionally engaging thesurface1180 of theblocker1018 and thesurface1146 of thebumper1016 abutting against and fixed to thesurface1182 of theblocker1018.
• With particular reference toFIGS. 47 and 48, the illustratedcord1022 includes anelongate body1190 with anenlarged end1192 and an opposed cut-to-length end1194. Theenlarged end1192 may be created by heating thecord1022 to melt the cord and create theenlarged end1192 that abuts against thesurface1046 of thesleeve1005 and is too large to enter thebore1034. Alternatively an outer pin or knob (not shown) may be fixed to thecord1022. In other embodiments of the invention a blocker and set screw combination, similar to theblocker1018 and setscrew1019 may be used to fix thecord1022 outside of thesleeve1005 and thus allow thecord1022 to be in slidable relationship with thesleeve1005. Thecord1022 may be made from a variety of materials, including polyester or other plastic fibers, strands or threads, such as polyethylene-terephthalate. A cord according to the invention typically does not illustrate elastic properties, such as any significant additional axial distraction and lengthening after theassembly1001 is operatively assembled and the cord is tensioned. However, it is foreseen that in some embodiments, thecord1022 may be made of an elastic or semi-elastic material, such as a plastic or rubber (natural or synthetic) having at least some elastic properties, allowing for some further distraction of theassembly1001 during operation thereof. The core can also be a cable-like structure made of metal.
• With particular reference toFIGS. 69-89 thereference number1025 generally represents a polyaxial bone screw apparatus or assembly in accordance with the present invention operably utilized by implantation into a vertebra (not shown) and in conjunction with the connectingmember assembly1001 of the invention. Thebone anchor assembly1025 generally includes ashank1206, areceiver1207, a retainer structure orring1208, alower pressure insert1209 and a closure structure or top1210.
• Theshank1206 is elongate and has anupper body portion1214 integral with alower body portion1215, ending in a tip1216. Theshank body1215 has a helically wound boneimplantable thread1217 extending from near a tip1216 to near atop area1218 of thelower body1215 and extending radially outward therefrom. During use, thebody1215 utilizing thethread1217 is implanted into a vertebra. Theshank1206 has an elongated axis of rotation generally identified by the reference letter B.
• Axially extending outward and upward from theshank body1215 is aneck1220 that in some embodiments is of reduced radius as compared to the adjacenttop area1218 of thebody1215. Further extending axially and outwardly from theneck1220 is the shankupper portion1214 operably providing a connective or capture structure free from the bone or vertebra for joining with thereceiver1207. The shank upper portion orcapture structure1214 has a frusto-conical surface1222 located adjacent to theneck1220 and extending outwardly to an undercutsurface1224 of a substantially spherical or domed shapedsurface1226 that is centrally radiused. The undercutsurface1224 forms an oblique angle with respect to the substantiallyconical surface1222 as well as to the axis B. In some embodiments of the invention, thesurface1224 may be substantially perpendicular to the frusto-conical surface1224 or in other embodiments, thesurface1224 may be substantially perpendicular to the axis B. However, it has been found that providing an undercut or oblique relationship between thedomed surface1226 and the frusto-conical surface1222 results in better fixation of theretainer1208 to the bone screw shankupper body portion1214 as will be described in greater detail below. Also formed in the shankupper portion1214 within anannular rim1228 of thesurface1226 is atool engagement aperture1231 for engagement by a tool driving head (not shown) that is sized and shaped to fit into the aperture for both driving and rotating theshank1206 into a vertebra. In the illustrated embodiment, theaperture1231 is hex-shaped and runs parallel to the axis B. It is foreseen that various sizes, shapes and numbers of apertures, slots or the like may be utilized in accordance with the invention for engaging a driving tool of suitable and similar mating shape. The illustratedshank1206 is cannulated, having a throughbore1232 extending an entire length of theshank1206 along the axis B. Thebore1232 is defined by an inner cylindrical wall of theshank1206 and has a circular opening at theshank tip1206 and an upper opening communicating with theinternal drive feature1231. Thebore1232 provides a passage through theshank1206 interior for a length of wire (not shown) inserted into the vertebra (not shown) prior to the insertion of theshank body1215, the wire providing a guide for insertion of theshank body1215 into the vertebra (not shown).
• To provide a biologically active interface with the bone, the threadedshank body1215 may be coated, perforated, made porous or otherwise treated. The treatment may include, but is not limited to a plasma spray coating or other type of coating of a metal or, for example, a calcium phosphate; or a roughening, perforation or indentation in the shank surface, such as by sputtering, sand blasting or acid etching, that allows for bony ingrowth or ongrowth. Certain metal coatings act as a scaffold for bone ingrowth. Bio-ceramic calcium phosphate coatings include, but are not limited to: alpha-tri-calcium phosphate and beta-tri-calcium phosphate (Ca₃(PO₄)₂, tetra-calcium phosphate (Ca₄P₂O₉), amorphous calcium phosphate and hydroxyapatite (Ca₁₀(PO₄)₆(OH)₂). Coating with hydroxyapatite, for example, is desirable as hydroxyapatite is chemically similar to bone with respect to mineral content and has been identified as being bioactive and thus not only supportive of bone ingrowth, but actively taking part in bone bonding.
• Thereceiver1207 has a generally squared-off U-shaped appearance with a partially cylindrical inner profile and a substantially faceted outer profile; however, the outer profile could also include other geometrical configurations. Side surfaces of thereceiver1207 that are closely received by theflanges1036 and1037 of thesleeve1005 or theflanges1110 and1112 of thesleeve1007 are preferably planar. A receiver axis of rotation C is aligned with the axis of rotation B of theshank1206 during assembly of thereceiver1207 with theshank1206 and theretainer1208. After thereceiver1207 is pivotally connected to theshank1206, and such assembly is implanted in a vertebra (not shown), the axis C is typically disposed at an angle with respect to the axis B of theshank1206.
• With reference toFIGS. 69-88, thereceiver1207 has a base1233 with a pair ofupstanding arms1234 and1235 forming a U-shaped channel1238 between thearms1234 and1235 having alower seat1239. Opposedplanar side surfaces1236 and1237 also define the channel1238 and extend upwardly from thebase1233 and totop surfaces1240 of the arms. Theinsert1209 that is disposed within thereceiver1207 is sized and shaped to closely receive thesleeve1005body surface1038 or thesleeve1007body surface1106. Each of thearms1234 and1235 has aninterior surface1241 that includes a partial helically wound guide andadvancement structure1242. In the illustrated embodiment, the guide andadvancement structure1242 is a partial helically wound flangeform that mates under rotation with a similar structure on theclosure top1210, as described below. However, it is foreseen that the guide andadvancement structure1242 could alternatively be a buttress thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structures for operably guiding under rotation and advancing the closure top between thearms1234 and1235. Also, non-helically wound closure tops or caps are foreseen.Tool engaging apertures1244 are formed on the outsides of thearms1234 and1235 for holding thereceiver1207 during certain assembly steps and/or implantation of the assembly and also for access to a thindeformable wall1245 during assembly with thepressure insert1209.
• A chamber orcavity1247 is located within thereceiver base1233 that opens upwardly into the U-shaped channel1238. Thecavity1247 includes a partial spherical shapedsurface1248, at least a portion of which forms a partial internal hemispherical seat for theretainer1208, as is described further below. Alower neck1250 defining a lower bore further communicates between thecavity1247 and the bottom exterior of thebase1233 and is coaxial with the rotational axis C of thereceiver1207. Theneck1250 at least partially defines a restriction having a radius which is smaller than the radius of theretainer1208 when the retainer is fully engaged with the frusto-conical surface1222 of theshank1206, so as to form a restrictive constriction at the location of theneck1250 relative to theretainer1208 to prevent theretainer1208 from passing between thecavity1247 and the lower exterior of thereceiver1207.
• In an upper portion of thecavity1247, a substantiallycylindrical surface1252 includes a run-out surface1253 located directly beneath the guide andadvancement structure1242. With particular reference toFIGS. 82-83 and87-88, formed in thesurface1253 under thestructure1242 of both of thearms1234 and1235 is arecess1254 partially defined by a stop orabutment wall1255. As will be described in greater detail below, the cooperatingcompression insert1209 includes a protrudingstructure1294 on each arm thereof that abuts against therespective wall1255 of each of the receiver arms, providing a centering stop when theinsert1209 is rotated into place as will be described below.
• With particular reference toFIGS. 76-81, theretainer1208 is an open and substantially ring-shaped and has an operational central axis which is the same as the elongate axis B associated with theshank1206, but when theretainer1208 is separated from theshank1206, the axis of rotation is identified as axis D. Theretainer1208 has acentral bore1256 that passes entirely through theretainer1208 from atop surface1258 to abottom surface1259 thereof. Thebore1256 is substantially formed by a frusto-conical surface1257, sized and shaped to fit snugly over the shank capture structure frusto-conical surface1222 in such a manner as to allow sliding axial movement therebetween during assembly and substantially full contact between thesurface1257 and thesurface1222 during operation, as described below.
• As stated above, theretainer1208 is open, having a through-gap running from thetop surface1258 through thebottom surface1259, the gap formed by facingsurfaces1260 and1261. The illustratedsurfaces1260 and1261 are substantially parallel, both running substantially perpendicular to the top andbottom surfaces1258 and1259. It is foreseen that in other embodiments of the invention, thesurfaces1260 and1261 may form and oblique angle with the top andbottom surfaces1258 and1259. With particular reference toFIGS. 70 and 80, the gap between thesurfaces1260 and1261 is sized such that thesurfaces1260 and1261 may be moved toward one another, squeezing theretainer1208 about theshank neck1220 during assembly such that theretainer1208 and shankupper portion1214 may be inserted into and through theneck1250 of thereceiver1207 and into thereceiver cavity1247 wherein theretainer1208 may be released and allowed to expand to a natural state thereof, capturing both theretainer1208 and the shankupper portion1214 within thereceiver cavity1247.
• Theretainer top surface1258 includes a cut or notch, generally1262 that appears substantially v-shaped in cross-section. Specifically, thecut1262 is defined by a substantially curved orspherical surface1263 and a contiguous partially conical or slopingsurface1264. Thenotch1262 is located near the frusto-conical surface1257, with thesloping surface1262 extending to or near thesurface1257. In the illustrated embodiment, thesurface1262 extends to a rounded or beveledannular surface1266 that opens to thesurface1257 that defines theinner bore1256. Thecurved surface1263 has a radius that is the same or substantially similar to the radius of thedomed surface1226 of the shankupper body portion1214. Theconical surface1264 is sized and shaped to be closely received by the undercutsurface1224 of the shankupper body portion1214. Thus, when thesurface1257 engages theshank surface1222 and is slid axially toward thedomed surface1226 during assembly, the shank undercut1224 engages thesurface1264 and thespherical surface1263 of thenotch1262 engages a portion of thedomed surface1226, advantageously providing a stop and a secure fit between theretainer1208 and the shankupper body portion1214 within thereceiver1207.
• Theretainer1208 has a radially outer partial hemispherical shapedsurface1265 sized and shaped to mate with the partial spherical shapedsurface1248 of thereceiver1207 and having a radius approximately equal to a radius associated with thesurface1248. Theretainer1208 radius (when in an operational non-squeezed orientation) is larger than the radius associated with the annular curved surface1229 of the shankupper portion1214 and also substantially larger than the radius of thereceiver neck1250.
• With particular reference toFIGS. 84-88, the lower compression orpressure insert1209 includes a substantiallycylindrical body1270 integral with a pair ofupstanding arms1272. Thebody1270 andarms1272 form a generally U-shaped, open, through-channel1274 having alower seat1276 sized and shaped to closely, snugly engage thesleeve1005 or thesleeve1007. Thearms1272 disposed on either side of thechannel1274 extend outwardly from thebody1270. Thearms1272 are sized and configured for placement near the run-out1253 below the guide andadvancement structure1242 at the receiverinner arms1234 and1235. Each of thearms1272 includes atop surface1278 ultimately located directly beneath the guide andadvancement structure1242, but are not directly engaged by theclosure top1210. However, in some embodiments of the bone screw for use with other longitudinal connecting members, the closure top may directly engage thetop surfaces278 for locking the polyaxial mechanism of theassembly1025. Therefore, theassembly1 may be used with a wide variety of longitudinal connecting members, including thesleeves1005 and1007 or inelastic or deformable rods or other connecting members that engage theclosure top1210 and are locked into position bysuch closure top1210 as well as rods of smaller diameter or, for example cords that are captured by theclosure top1210, but are otherwise movable within thereceiver1207 and are thus in slidable or spaced relation with theclosure top1210. Eacharm1272 further includes a partially cylindricalouter surface1280 sized and shaped to fit within thereceiver1207 at the guide andadvancement structure1242 run-out relief1253. Thecylindrical surfaces1280 are disposed substantially perpendicular to the respective adjacenttop surfaces1278. In some embodiments of the invention recesses are formed near and/or at thetop surfaces1278 and the surfaces that form thechannel1274 to provide relief for material flow of the longitudinal connecting member, when, for example, the connector is made from a deformable plastic. For example, a recessed surface or groove may be directed downwardly and inwardly toward thechannel1274. Each of theouter surfaces1280 further includes arecess1282 sized and shaped to receive holding tabs or crimped material from thereceiver1207. For example, as shown inFIG. 71, thethin walls1245 of thereceiver1207 are pressed into therecesses1282 to prevent counter-clockwise rotation of theinsert1209 about the axis C with respect to thereceiver1207. In other embodiments of the invention, thereceiver1207 may be equipped with spring tabs that snap into therecesses1282 to hold theinsert1209 in place with respect to counter-clockwise rotation. Therecesses1282 are preferably oval or elongate such that some desirable upward and downward movement of theinsert1209 along the axis C of thereceiver1207 is not prohibited. As previously described herein thecompression insert1209 arms each include the protrudingstructure1294 located on opposite sides of the arms such that when theinsert1209 is dropped down into thereceiver1207 as shown by the arrow M inFIG. 87 and then rotated into place in a clockwise direction as shown by the arrow N inFIG. 88, thestructure1294 abuts thewall1255 of the recessed area2154 when the insert is in a desired centered location with theapertures1282 in alignment with theapertures1244.
• Thecompression insert1209 further includes an innercylindrical surface1284 that forms a through bore sized and shaped to receive a driving tool (not shown) therethrough that engages theshank drive feature1231 when theshank body1215 is driven into bone. Theinner surface1284 runs between theseating surface1276 and an inner curved, annular, radiused orsemi-spherical surface1286. Thesurface1286 is sized and shaped to slidingly and pivotally mate with and ultimately fix against the annulardomed surface1226 of the shankupper portion1214. Thus, a radius of thesurface1286 is the same or substantially similar to the radius of thesurface1226. Thesurface1286 may include a roughening or surface finish to aid in frictional contact between thesurface1286 and thesurface1226, once a desired angle of articulation of theshank1206 with respect to thereceiver1207 is reached. Adjacent to theinner surface1286 is a bottom rim oredge1288. Adjacent to the outercylindrical surface1280 of thearms1272 is a substantially frusto-conical surface1290 that extends inwardly toward thelower rim1288. Thesurface1290 includes portions of thearms1272 as well as partially defining thepressure insert body1270.
• Thepressure inset body1270 located between thearms1272 has an outer diameter slightly smaller than a diameter between crests of the guide andadvancement structure1242 of thereceiver1207 allowing for top loading of thecompression insert1209 into thereceiver1207 through the U-shaped channel1238, with thearms1272 being located between thearms1234 and1235 during insertion of theinsert1209 into the receiver1207 (seeFIG. 87). As explained above, once located between the guide andadvancement structure1242 and the shankupper portion1214, theinsert1209 is rotated into place about the axis C until thearms1272 are directly below the guide andadvancement structure1242 at or near the run-out1253 and thestructure1294 abuts against thewall1255 of therecess1254. After theinsert1209 is rotated into such position, a tool (not shown) may be inserted into thereceiver apertures1244 to press thethin receiver walls1245 into the insert recesses1282. Thelower compression insert1209 is sized such that theinsert1209 is ultimately received within thecylindrical surface1252 of thereceiver1207 below the guide andadvancement structure1242. Thereceiver1207 fully receives thelower compression insert1209 and blocks thestructure1209 from spreading or splaying in any direction. It is noted that assembly of theshank1206 with theretainer1208 within thereceiver1207, followed by insertion of thelower compression insert1209 into thereceiver1207 are assembly steps typically performed at the factory, advantageously providing a surgeon with a polyaxial bone screw with thelower insert1209 already held in alignment with thereceiver1207 and thus ready for insertion into a vertebra.
• The compression orpressure insert1209 ultimately seats on thesurface1226 of the shankupper portion1214 and is disposed substantially in the uppercylindrical portion1252 of thecavity1247, with the receiverdeformable walls1245 engaging theinsert1209 at therecesses1282, thereby cooperating with thewalls1255 of therecesses1254 to hold theinsert1207 in desired alignment.
• With particular reference toFIGS. 69-71, the closure structure or closure top1210 can be any of a variety of different types of closure structures for use in conjunction with the present invention with suitable mating structure on theupstanding arms1234 and1235. In the embodiment shown, theclosure top1210 is rotatably received between the spacedarms1234 and1235 of thereceiver1207. The illustratedclosure structure1210 is substantially cylindrical and includes an outer helically wound guide andadvancement structure1295 in the form of a flange form that operably joins with the guide andadvancement structure1242 of thereceiver1207. The flange form utilized in accordance with the present invention may take a variety of forms, including those described in Applicant's U.S. Pat. No. 6,726,689, which is incorporated herein by reference. It is also foreseen that according to the invention the closure structure guide and advancement structure could alternatively be a buttress thread, a square thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structure for operably guiding under rotation and advancing theclosure structure1210 downward between thearms1234 and1235 and having such a nature as to resist splaying of thearms1234 and1235 when theclosure structure1210 is advanced into the channel1238. The illustratedclosure structure1210 also includes atop surface1296 with aninternal drive1297 in the form of an aperture that is illustrated as a star-shaped internal drive, but may be, for example, a hex-shaped drive or other internal drives, including, but not limited to slotted, tri-wing, spanner, two or more apertures of various shapes, and the like. A driving tool (not shown) sized and shaped for engagement with theinternal drive1297 is used for both rotatable engagement and, if needed, disengagement of theclosure210 from thereceiver arms1234 and1235. It is also foreseen that theclosure structure1210 may alternatively include a break-off head designed to allow such a head to break from a base of the closure at a preselected torque, for example, 70 to 140 inch pounds. Such a closure structure would also include a base having an internal drive to be used for closure removal. Abottom surface1298 of theclosure top1210 is planar and is sized and shaped to engage thesleeve1005 or thesleeve1007 atrespective surfaces1038 and1106.
• Theclosure top1210 may further include a cannulation through bore extending along a central axis thereof and through a surface of thedrive1297 and thebottom surface1298. Such a through bore provides a passage through theclosure1210 interior for a length of wire (not shown) inserted therein to provide a guide for insertion of the closure top into thereceiver arms1234 and1235.
• When the polyaxial bone screw assembly1201 is placed in use in accordance with the invention theretainer1208 is normally inserted about the shank at or near theneck1220 by spreading theretainer1208, moving thesurfaces1260 and1261 away from one another and enlarging the gap therebetween so that theretainer surfaces1260 and1261 clear the area of theneck1220 until theretainer1208 substantially surrounds theshank1206 at or near theneck1220. Thereafter, the retainer is squeezed or pressed, bringing thesurfaces1260 and1261 into contact or close proximity as shown inFIG. 80. Thereafter, theshank1206 and compressedretainer1208 are inserted into thereceiver1208 at thereceiver neck1250 and up into thereceiver cavity1247 where theretainer1208 is released and allowed to return to an original shape with a gap between thesurfaces1260 and1261. The shankupper portion1214 is then pulled axially downwardly toward thereceiver neck1250 with thesurface1257 of theretainer1208 sliding along the frusto-conical surface1222 of the shankupper portion1214 until theretainer notch1262 engages the shank upper portion undercut1224 with the retainerspherical surface1263 surrounding a portion of thedomed surface1226 of the shankupper portion1214 as shown, for example, inFIG. 81. At this point there is no substantial outward or downward pressure on theretainer1208 and so theretainer1208 is easily rotatable along with the now attachedshank1206 within thechamber1247 and such rotation is of a ball and socket type wherein the angle of rotation is only restricted by engagement of theshank neck1220 with theneck1250 of thereceiver1207.
• Then, theinsert1209 is inserted into the channel1238 with thearms1272 aligned in the channel1238 between the guide andadvancement structures1242. Theinsert1209 is then moved downwardly in the channel1238 and toward thecavity1247. With reference toFIGS. 87-88, once thearms1272 are located generally below the guide andadvancement structure1242 and adjacent the run-out relief1253, theinsert1209 is rotated 90 degrees in a clockwise direction about the axis C of thereceiver1207. Thearms1272 fit within thecylindrical walls1252 above thecavity1247. Once thestructures1294 abut against thewalls1255, thearms1272 are desirably located directly below the guide andadvancement structures1242, rotation is ceased and a tool (not shown) is used to press thethin walls1245 of thereceiver1207 into therecesses1282 of theinsert1209. Theinsert1209 is now locked into place inside thereceiver1207 with the guide andadvancement structures1242 prohibiting upward movement of the insert out of thechannel238.
• As illustrated inFIG. 71, theinsert1209 seats on the shankupper portion1214 with thesurface1286 in sliding engagement with thesurface1226. The run-out orrelief1253 is sized and shaped to allow for some upward and downward movement of theinsert1209 toward and away from the shankupper portion1214 such that theshank1206 is freely pivotable with respect to thereceiver1207 until theclosure structure1210 presses on thesleeve1005 or thesleeve1007 that in turn presses on theinsert1209 that in turn presses upon theupper portion1214 into locking frictional engagement with thereceiver1207 at thesurface1248.
• The resulting assembly is then normally screwed into a bone, such as vertebra, by rotation of theshank1206 using a suitable driving tool (not shown) that operably drives and rotates theshank1206 by engagement thereof at theinternal drive1231.
• Theassembly1001 may be assembled as follows: First, after the twobone screws1025 are implanted, the distance between the screws is measured. Thereafter, the spacer/liner combination1010 (or in some embodiments a spacer without the liner) is cut to a desired length based upon the measurement made between the bone screws. As described above, thespacer1012 and theoptional liner1013 that form the spacer/liner combination1010 are typically assembled at the factory, with theliner1013 being fixed to thespacer1012 along the spacer innercylindrical surface1072. The spacer/liner combination1010 is cut at the spacer end1076 (that is also the liner end1096) that is opposite the graduated end of thespacer1012. A tool (not shown), similar to a pipe cutter is usually used to rotate and cut the spacer/liner combination1010 to the desired length. Also at this time, in view of the resulting spacer/liner1010 length, asleeve1007 of a desired size is chosen. Because thesleeve1007 is made from a hard material, typically a metal or metal alloy, it is not practical to cut thetube portion1100 of thesleeve1007 to a desired length during the surgical procedure. Therefore, a variety ofsleeves1007 are typically provided to end users having at least threedifferent tube portion1100 lengths. See, for example,FIG. 95 that shows three different sizes of asleeve1307,1307′ and1307″ of the assembly1301 which are sleeves identical in form and function to thesleeve1007 and differing only in their length.
• With particular reference toFIGS. 47 and 48, thesleeve1005 is then slid onto thecord1022 at thecord end1194, with theend1194 being inserted into the throughbore1034 at thesleeve end1046 and out thesleeve end1064. Thesleeve1005 is then fed along thecord1022 until the sleeve end1052 is adjacent theenlarged cord end1192. It is noted that thecord1022 is typically much longer than shown in the drawing figures and then cut to length near theend1194 after being fully assembled with the remaining elements of theassembly1001, tensioned and fixed to theblocker1018. After thesleeve1005 is in place on thecord1022, the spacer/liner combination1010 is loaded with thecord end1194 being inserted into the flaredopening1080 at theend1074, the innercylindrical surface1082, the innercylindrical surface1084 and thereafter, theliner bore1092 and out theliner end1096 andspacer end1076. The spacer/liner combination1010 is slid along thecord1022 until theend1074 contacts thetubular extension1032 of thesleeve1005. A tensioning device (not shown) is typically needed to push and/or pull thespacer1012 against and over portions of thetubular extension1032 of thesleeve1005 until thesurface1074 of the spacer abuts thesurface1047 of thesleeve flange1037, the innercylindrical surface1082 of thespacer1012 fully engages the outercylindrical surface1056 of thetubular extension1032 and the innercylindrical surface1084 of thespacer1012 fully engages the outercylindrical surface1060 of thetubular extension1032. At this time, thesleeve1005 is fixed against thespacer1012 and both the spacer/liner combination1010 and thesleeve1005 are in sliding relationship with thecord1022. It may be necessary to warm thespacer1012 prior to assembly with thetubular extension1032 to allow for stretching and expansion of thespacer1012 graduated inner surface (surfaces1080,1082,1084, and1086) to fit about the knob defined by the tubular extensionannular wall1058 andcylindrical surface1060. Thesleeve1007 is then loaded with thecord end1194 being inserted into the throughbore1104 at theopening surface1131 near theend1128 and out theopening1125 at theend surface1124. Thesleeve1007 is then slid along thecord1022 with thetubular extension1100 sliding into theliner bore1092. Thereafter, theblocker1018 withpre-attached bumper1016 and loosely mated set screw1019 (as shown inFIGS. 65-67) is loaded onto thecord1022 with thecord end1194 being inserted into thebumper bore1152 at the opening located near thebumper end1144 and exiting the blocker bore opening near theend surface1178. Thebumper1016 and attachedblocker1018 are slid along thecord1022 until thebumper end1144 abuts against thesleeve1007flange1112end surface1124. The resulting loosely held together assembly as shown, for example, inFIG. 48, is now ready for pre-tensioning or for placement in and between the implantedbone screws1025, followed by tensioning, with theset screw1019 engaged with thecord1022 enough to prevent the elements from slipping off of thecord1022. It is noted that thecord1022 is typically much longer at this time (than shown inFIG. 48) so that the cord may be grasped and tensioned either before or after the assembly is fixed to the bone screws1025. If pre-tensioning is desired, at this time, prior to implanting the assembly, a tensioning tool (not shown) known in the art is used to pull upon and put tension on thecord1022 near theend1194. Thecord1022 is preferably tensioned until the bumper compresses as shown inFIGS. 45,46 and72 and then theset screw1019 is rotated and driven into theblocker1018 and up against thecord1022 using a driving tool (not shown) engaged with theinner drive1189.
• The assembly1001 (either pre-tensioned or in a loosely attached orientation) is implanted by inserting thesleeve1005body portion1038 into one of the bone screws1025 with thereceiver1207 being received between the twoflanges1036 and1037 and placing thesleeve1007body portion1106 into another of the bone screws1025 with therespective receiver1207 being received between the twoflanges1110 and1112. Closure tops1210 are then inserted into and advanced between thearms1234 and1235 of each of thereceivers1207 so as to bias or push against thesleeve1005 and thesleeve1007 atrespective surfaces1038 and1106. A driving tool (not shown) is inserted into eachdrive1297 to rotate and drive the respective closure top1210 into the cooperatingreceiver1207. Eachshank dome1226 is engaged by the cooperatinginsert1209 and pushed downwardly when theclosure top1210 pushes downwardly on thesleeve1005 orsleeve1007. The downward pressure on theshank1206 in turn urges theretainer1208 downwardly which exerts both a downward and outward thrust on theretainer1208 until theretainer surface1265 fully frictionally engages the receiverinner seating surface1248. Twopolyaxial bone screws1025, including the dynamic connectingmember assembly1001, are shown inFIGS. 45 and 72, illustratingvarious shank1206 toreceiver1207 angular configurations.
• If theassembly1001 has not been pre-tensioned, or if further tensioning is desired, a tensioning tool (not shown) known in the art is then used to pull upon and put tension on thecord1022 near theend1194. Thecord1022 is preferably tensioned until the bumper compresses as shown inFIGS. 45 and 72 and then theset screw1019 is rotated and driven into theblocker1018 and up against thecord1022 using a driving tool (not shown) engaged with theinner drive1189. Theblocker1018 advantageously includes opposed planar sides allowing for the placement of a counter-torque tool for holding theblocker1018 during tensioning and fixing of thecord1022 within the blocker. As explained above, theset screw1019 andblocker1018 combination include a limited travel feature such that theset screw1019 is locked into place at a location that firmly holds but does not damage thecord1022. Thecord1022 is then trimmed to a desired length near theblocker end1178.
• Theassembly1001 is thus substantially dynamically loaded and oriented relative to the cooperating vertebra, providing relief (e.g., shock absorption) and protected movement with respect to flexion, extension, distraction and compressive forces placed on theassembly1001 and the two connected bone screws1025. The flanges of thesleeves1005 and1007, now located outside of thebone screw receivers1207 are fully abuttingly engaged with the spacer/liner combination1010 and/or thebumper1016, thus fully supporting compression between thespacer1012 or thebumper1016 during flexion and extension. Furthermore, during complex spinal movements, thespacer1012 and1016 are able to move or flex away from and towards theflanges1036,1037 and1110,1112 without compromising the strength and integrity of theassembly1001. It is noted that a problem encountered with dynamic spinal implant systems is the need to provide adequate support with respect to bending sheer. Most spinal movements are not purely bending movements, e.g., flexion and extension. Most movements include both bending and tension, extension or compression. Such bending shear is not well resisted by a cord and spacer alone that performs well in tension, but not when the tension includes a vector force. The present invention advantageously provides a hard,non-elastic extension1100 of a rigid slidingsleeve body1099, theextension1100 further located within anon-elastic liner1013 of thespacer1012. Such features protect against vector forces while still allowing for advantageous tension of thecord1022 as well as improved compression provided by theouter bumper1016. Thecord1022 and thesleeve1007 allow for some twisting or turning, providing some relief for torsional stresses. Furthermore, thecompressed bumper1016 and the fixed contact between thesleeve1005 and thespacer1012 as well as the fixed contact between thebumper1016 and theblocker1018 places some limits on torsional movement as well as bending movement, to provide spinal support. The cord1022 (in tension) and bumper1016 (in compression) allow for compression and some extension of theassembly1001 located between the twobone screws1025, e.g., shock absorption. Another advantage of some of the embodiments of the present invention is that because of the inelastic sleeve extension that slides within the typically elastic spacer located between two bone screws, the resultingassembly1001 is more stable than a cord and spacer alone, therefore strength of the assembly does not rely upon the amount of tension placed upon the cord. Therefore, in certain embodiments according to the invention, it is not necessary to place as much tension on thecord1022 as would be required for a more traditional cord and spacer arrangement, thus protecting the cord from damage of over stressing.
• It is also noted that in other embodiments of a connectingmember1001 according to the invention, thesleeve1005 may be extended at theend1046 to provide a hard, non-elastic elongate portion for attachment to an additional bone screw or screws, if needed, to provide a connecting member with both dynamic, elastic segments as well as a longer rigid inelastic segment.
• If removal of theassembly1001 from any of thebone screw assemblies1025 is necessary, or if it is desired to release theassembly1001 at a particular location, disassembly is accomplished by using the driving tool (not shown) with a driving formation cooperating with theclosure structure1210internal drive1297 to rotate and remove theclosure structure1210 from thereceiver1207. Disassembly is then accomplished in reverse order to the procedure described previously herein for assembly.
• Eventually, if the spine requires more rigid support, the connectingmember assembly1001 according to the invention may be removed and replaced with another longitudinal connecting member, such as a solid rod or bar, having the same width or diameter as body portions of thesleeves1005 and1007, utilizing thesame receivers1207 and the same orsimilar closure structures1210. Alternatively, if less support is eventually required, a less rigid, more flexible assembly, for example, anassembly1001 having aspacer1012 andbumper1016 made of a softer more compressible material than the spacer and bumper being replaced thereby, also utilizing the same bone screws1025.
• With reference toFIGS. 89-95, an alternative longitudinal connecting member assembly according to the invention, generally1301, for use with threebone screws1025 includes afirst sleeve1305, asecond sleeve1307, athird sleeve1309, a first spacer/liner combination1310 and a second spacer/liner combination1311. The first spacer/liner combination1310 includes anouter spacer1312 and aninner liner1313 and the second spacer/liner combination1311 includes anouter spacer1314 and an inner liner1315. The illustrated spacer/liner combination1311 is identical to the spacer/liner combination1310 with the exception of a length thereof along a central axis A′. The assembly1301 further includes abumper1316, acord blocker1318 and mating setscrew1319 and acord1322. The assembly1301 is substantially similar to theassembly1001 with the exception of the addition of thethird sleeve1309 and the second spacer/liner combination1311. Thus, thefirst sleeve1305, thesecond sleeve1307, the first spacer/liner combination1310, thebumper1316, thecord blocker1318, theset screw1319 and thecord1322 are the same or substantially similar to the respectivefirst sleeve1005,second sleeve1007, spacer/liner combination1010,bumper1016,cord blocker1018, setscrew1019 andcord1022 of theassembly1001 previously discussed above and thus shall not be discussed further herein. Although only one additional sleeve3109 (and attached bone screw1025) and cooperating spacer/liner1311 are illustrated in the drawings, it is noted that the assembly1301 of the invention may be lengthened further and adapted for use with additional bone screws by simply addingmore sleeves1309 and cooperating spacer/liners1311 (or optionally spacers without liners) between thesleeve1305 and thesleeve1307.
• With particular reference toFIGS. 91-94, thesleeve1309 includes abody portion1330 generally sized and shaped for being received within thepolyaxial bone screw1025 and a firsttubular extension1332 sized and shaped to engage and hold thespacer1312 in fixed engagement with thesleeve1309. The sleeve also includes a second opposedtubular extension1333 sized and shaped to be slidingly received by the spacer/liner combination1311. The illustratedbody portion1330 andtubular extensions1332 and1333 are integral or otherwise fixed to one another. A throughbore1334 extends centrally through thebody portion1330 and centrally through both thetubular extensions1332 and1333 along the axis A′. Thebore1334 is sized and shaped to slidingly receive thecord1322 and when assembled with a remainder of the assembly1301, also extending along the axis A′. Thebody portion1330 further includes acylindrical body surface1338 located between radially extendingflanges1340 and1342, the flanges also being cylindrical in shape. Theflanges1340 and1342 further include respective innerplanar surfaces1344 and1346, respective outercylindrical surfaces1348 and1350 and respective outerplanar surfaces1352 and1354. Theflanges1340 and1342 are spaced from one another a desired distance so as to closely receive abone screw receiver1207 therebetween. Theflanges1340 and1342 are thus identical or substantially similar in form and function to theflanges1036 and1037 of thesleeve1005 and theflanges1110 and1112 of thesleeve1007 previously described herein with respect to theassembly1001.
• The outerplanar surface1354 is adjacent to a tapered surface1355 that extends toward and terminates at a firstcylindrical surface1356 of thetubular extension1332. The outercylindrical surface1356 terminates at a radially extending annular wall1358 that is perpendicular thereto. The wall1358 terminates at a second substantiallycylindrical surface1360 of greater outer diameter than thecylindrical surface1356. Thesurface1360 terminates at an annular inwardly tapering beveled surface1362. The bevel1362 is adjacent to a planarannular end surface1364 that is disposed perpendicular to thecylindrical surface1360. Thesurface1364 is adjacent to a flared orbeveled surface1365 that defines an opening of thebore1334. Thesurfaces1356,1358 and1360 provide a push-on connective element for attachment to inner surfaces of thespacer1312. Thesleeves1305,1307,1309, theliners1313 and1315 and thecord blocker1318 withset screw1319 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• Near thetubular structure1333, theflange1340 outerplanar surface1352 is adjacent to atapered surface1366 that extends toward and terminates at acylindrical surface1367 of thetubular extension1333. The outercylindrical surface1367 extends toward an annularplanar end surface1368 that is perpendicular thereto. Abeveled surface1370 spans between thecylindrical surface1367 and theend surface1368. Theend surface1368 terminates at a inner flaredsurface1371, thesurface1371 defining an opening of thebore1334. Upon assembly with thespacer1314/liner1315 combination, thecylindrical surface1367 is in slidable relationship with the inner surface of the liner1315. A desirable material for both the liner1315 and thetubular extension1333 is cobalt chromium. Furthermore, in some embodiments of the invention, in order to have low or no wear debris, the liner1315 inner surface and theouter surface1367 of thetubular extension1333 may be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments.
• As stated above, the spacer/liner combination1311 is identical to the spacer/liner combination1310 with the exception of length along the axis A′. Thus, the spacer/liner combination1311 is identical or substantially similar to the spacer/liner combination1010 previously described herein. With reference toFIG. 90, during assembly, thespacer1312 is press-fitted over thetubular extension1332 of thesleeve1309 while thespacer1314 is press fitted over the tubular extension of thesleeve1305. Thus, the elements are loaded onto thecord1322 as follows: thesleeve1305, followed by the spacer/liner combination1311, followed by thesleeve1309, followed by the spacer/liner combination1312 followed by thesleeve1307, followed by thebumper1316 and attachedblocker1318 withset screw1319. The assembly1301 is implanted with each of thesleeves1305,1307 and1309 being attached to abone screw1025 as shown inFIG. 90. Either before or after the sleeves are attached to the bone screws1025, thecord1322 is tensioned as previously described with respect to theassembly1001. Thus, the fully assembled and dynamically loaded assembly1301 allows for translation of thereceivers1207 of all three of the bone screws1025 along the tensionedcord1322 while at the same time all threesleeves1305,1307 and1309 are fixedly coupled to a respectivebone screw receiver1207. Furthermore, thetubular extension1333 of thesleeve1309 as well as the tubular extension of thesleeve1307 glide within spacer/liner combinations1310 and1311, protecting the assembly from bending shear forces while allowing for the desired movement of all threescrews1025 with respect to the tensionedcord1322.
• With reference toFIG. 95, a portion of a kit according to the invention is shown showing three differentsized sleeves1307, the shortest being identified as1307, a mid-length sleeve as1307′ and a longer sleeve as1307″. The kit also illustrates three differentsized sleeves1309 with the shortest being identified as1309, the mid-length sleeve as1309′ and thelongest sleeve1309″. Onesize sleeve1305 is illustrated. Thus, as described previously with respect to theassembly1001, when utilizing the assembly1301 a surgeon may choose various lengths ofsleeves1307 and1309 that best match the measurements made of distances between a patient's vertebrae.
• With reference toFIGS. 96-122 another longitudinal connecting member assembly according to the present invention, generally2401 is shown attached to five polyaxial bone screws2001. Generally, each bone screw includes ashank2004, areceiver2010, anopen retainer2012 for holding theshank2004 upper portion2008 within thereceiver2010 and aninsert2014 having a substantially planar top surface for engagement with sleeves of theassembly2401. The connectingmember assembly2401 is elongate, having a substantially central axis F. With particular reference toFIGS. 96-99, the illustrated connectingmember assembly2401 generally includes at least first, second and third hard, inelasticflanged sleeves2405,2406 and2407 with a first spacer/liner combination, generally2410, a second spacer/liner combination, generally2411 and athird spacer2412 located therebetween. It is noted that the spacer/liner combinations may be replaced by a spacer alone in other embodiments of the invention. The illustrated first spacer/liner combination2410 includes anouter spacer2413 and aninner liner2414 and the second spacer/line combination2411 includes anouter spacer2415 and aninner liner2416. Theassembly2401 further includes anelastic bumper2417, acord blocker2418 with cooperating setscrew2419 and an inner core that in the present embodiment is acord2422. Theassembly2401 further includes a cord/rod coupler2424 and a threadedrod2425. Thecord2422 extends from the cord/rod coupler2424 along the axis F and successively through and within thespacer2412, thesleeve2407, thespacer2415, the sleeve2406 (and spacer/liner2411), thespacer2413, the sleeve2405 (and spacer/liner2410), thebumper2417 and thecord blocker2418 as shown, for example, inFIG. 99. InFIGS. 96 and 99, theassembly2401 is shown attached to three polyaxial bone screws, generally2001, described more fully below at thesleeves2405,2406 and2407. As best shown inFIG. 99, two of the bone screws2001 are attached to thesleeves2405 and2406 with a slide or slippingclosure top2430 and one of the bone screws is attached to thesleeve2407 with agripping closure top2431. As will be discussed in greater detail below, the slide or slipclosure top2430 engages a respective sleeve but not thecord2422, allowing the cord to slip or slide within thepolyaxial screw2001. Thegrip closure top2431 extends through the sleeve and grips and fixes thecord2422 against a surface of the sleeve and thus fixes the cord in relation to thepolyaxial screw2001. Finally, two of the illustratedbone screws2001 are attached to therod2425 with a point andrim closure top2432. The closure tops2430,2431 and2432 are shown in greater detail inFIGS. 117-122.
• A portion of thesleeve2405 extends into and through the spacer/liner2410 and is in slidable relationship therewith. Likewise, a portion of thesleeve2406 extends into and through the spacer/liner2411. Such spacer overlap with respect to thesleeves2405 and2406 provides advantageous anti-shear support for theconnector2401. A portion of thecord blocker2418 also extends into a bore of thebumper2417. Thebumper2417 is typically made from an elastomer while theouter spacers2412,2413 and2415, although typically elastomeric, may be made from a material with a different durometer, typically (but not always) being tougher and less compressible than the material of thebumper2417. Thesleeves2405,2406 and2407 and thespacer liners2414 and2416 are made from a hard, non-elastic material, such as a metal or metal alloy, like cobalt chromium. The hard and stiff slidingsleeves2405 and2406 each include an extension that slides into therespective liner2414 and2416, providing a dynamic no- or low-wear, sliding relationship between the sleeves and respective cooperating liners that is non-binding, and provides excellent shear resistance while at the same time, the optionalthin liners2414 and2416 cooperating with the respectiveelastomeric spacers2412,2413 and2415 as well as the tensionedcord2422 provide controlled bending, with the tensionedcord2422 and compressedbumper2417, performing well under tension and compression. Flanged portions of thesleeves2405,2406 and2407 are located on either side of thebone screw receivers2010, the flanges abutting against thespacers2412,2413,2415 or thebumper2417, the flanges extending radially outwardly to an extent to fully engage ends of adjacent spacers or thebumper2417, resulting in a stable, secure, substantially full contact between the individual elements of theassembly2401. Furthermore, the flanges allow for assembly and dynamic setting of the assembly prior to implantation, if desired, with thecord2422 being placed in tension and at least thebumper2417 being placed in compression. In some embodiments of the invention, tensioning of thecord2422 and compression of thebumper2417 and optionally thespacers2412,2413 and2415 may be performed after theassembly2401 is attached to the bone screws2001. It is noted that in some embodiments of the invention, thebumper2417 and cooperatingblocker2418 may be eliminated and a gripping closure top2431 may be inserted at an end orterminal bone screw2001 for gripping and fixing the cord in tension.
• With particular reference toFIGS. 100-104, thesleeve2405 further includes abody portion2434 generally sized and shaped for being received within thepolyaxial bone screw2001receiver2010 and atubular extension2435 sized and shaped to be slidingly received in the spacer/liner combination2410. The illustratedbody portion2434 andtubular extension2435 are integral or otherwise fixed to one another. A throughbore2436 extends centrally through thebody portion2434 and centrally through thetubular extension2435. Thebore2436 is sized and shaped to slidingly receive thecord2422 and when assembled with a remainder of theassembly2401, extends along the axis F. Thebody portion2434 further includes a pair of spaced radially extendingflanges2437 and2438 with a partially cylindrical and partially planar body portion being located therebetween, the body portion having an enlarged or protruding portion or portions illustrated as opposed substantiallycylindrical extensions2439, sized and shaped to closely fit within a cylindrical surface portion of thebone screw receiver2010. Theportions2439 function to center the sleeve within thebone screw receiver2010 and also advantageously strengthen the sleeve, resulting in better load transfer. It is foreseen that in some embodiments of the invention, thebody2434 with centeringstructure2439 may be configured to also extend down into the receiver and abut the bone screw shank upper portion2008 and thus eliminate thecompression insert2014. Furthermore, in some embodiments, theflanges2437 and2438 may be reduced or eliminated as the centering of the sleeve with respect to thebone screw receiver2010 is performed by the portion orportions2439.
• In the illustrated embodiment, theflanges2437 and2438 are substantially cylindrical having opposed planar and annular side surfaces spaced for closely receiving thebone screw2001receiver2010. Theflange2437 also defines an end of the sleeve while theflange2438 is located at a juncture of thebody2434 and thetubular extension2435. Thebody portion2439 is sized and shaped to be receivable within and frictionally fixed to a variety of monoaxial or polyaxial screw heads or receivers, including thereceiver2010. At anend2440, the sleeve2405 (and optional liner) may be cut to length. Abore2441 is formed in thebody2434 between theflanges2437 and2438, thebore2441 communicating with the throughbore2436. Thebore2439 is sized and shaped to receive the closure top2431 therein for frictionally gripping thecord2422 against an internal surface defining the throughbore2436, and thus placing thecord2422 in fixed relation with thebone screw receiver2010, if desired.
• Thesleeve2405, as well as thesleeves2406 and2407, theliners2414 and2416, thecord blocker2418 withset screw2419 and the cord/rod coupler2424 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• Thespacers2412,2413 and2415 are each substantially cylindrical in form, having outer cylindrical surfaces and inner through bores of a substantially constant inner diameter for receiving a sleeve portion and/orliner2414 or2416 and having graduated or various inner diameters at an end thereof for overlapping and fixing to a sleeve or the cord/rod coupler. Theoptional liner2414 closely fits within the through bore of thespacer2413 and the liner optional2416 closely fits within the through bore of thespacer2415. In fact, the spacer/liner combination2410 and the spacer/liner combination2411 are typically assembled or manufactured with the respective liner being fixed to the inner surface defining the bore of the spacer such that a surgeon receives such a spacer/liner combination already assembled and ready for the surgeon to cut the spacer/liner combination to a desired length at a non-graduated end thereof that is adhered or otherwise fixed the liner, as will be described in greater detail below. Thespacers2412,2413 and2415 are typically elastic and made from a plastic, for example, a thermoplastic elastomer made from a polyurethane or polyurethane blend, such as a polycarbonate urethane. Thespacers2413 and2415 include respective various and graduatedinner end surfaces2442 and2443 that are sized and shaped to be press fit over a knobbed feature of an adjacent sleeve or cord/rod coupler as will be described in greater detail below. Thespacer2412 also includes such a knob receiving feature on one or both ends thereof.
• The optionalinelastic liners2414 and2416 are substantially cylindrical and tubular in form, having a constant outer cylindrical surface and a constant inner cylindrical through bore. An end surface of each liner is disposed flush to the respective overlapping spacer, such surfaces being the cut-to-length side of the spacer/liner combination. Theliners2414 and2416 may be made from a variety of non-elastic materials, including metals, metal alloys and some plastics, with cobalt chromium being a preferred material. As stated above, the inner cylindrical surfaces of the liners are sized and shaped to slidingly receive a tubular extension of theinelastic sleeves2405 or2406.
• With particular reference toFIGS. 105-107, thesleeve2406 includes abody2444, atubular extension2445, a throughbore2446,flanges2447 and2448 with a centeringbody portion2449 therebetween, anend2450 and a closuretop receiving bore2451 that are substantially the same or similar in form and function to therespective body2434,tubular extension2435, throughbore2436,flanges2437 and2438,body portion2439,end2440 and closuretop receiving bore2441 previously described herein with respect to thesleeve2405. Unlike thesleeve2405 wherein theflange2437 defines one end of the sleeve, thesleeve2406 includes a knobbedstructure2452 disposed near theflange2447 and opposite theend2450. The knobbedstructure2452 provides a push-on connective element for attachment to inner graduatedsurfaces2442 of thespacer2413. It is noted that more than one size ofsleeve2405 and/or2406 is typically provided to the surgeon, the sleeves differing only in the length of thetubular extension2435 or2445, so as to appropriately match the size of the patient's spine. Also, a desirable material for both the liners and the sleeve tubular extensions is cobalt chromium. Furthermore, in some embodiments of the invention, in order to have low or no wear debris, the liner inner surface and the outer surfaces of the sleeve tubular extensions may be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments. It is further noted that inner surfaces of the sleeves that receive thecord2422 may also be likewise coated to provide a slick, low to no wear debris interface with thecord2422.
• With particular reference toFIGS. 108-110, thesleeve2407 includes abody2454, a throughbore2456,flanges2457 and2458 with a centeringbody portion2459 therebetween, and a closuretop receiving bore2461 that are substantially the same or similar in form and function to therespective body2434, throughbore2436,flanges2437 and2438,body portion2439, and closuretop receiving bore2441 previously described herein with respect to thesleeve2405. Unlike thesleeves2405 or2406, thesleeve2407 includes knobbedstructures2460 and2462 disposed at either end thereof. Theknobbed structures2460 and2462 are the same or similar to the knobbedstructure2452 described above with respect to thesleeve2406, providing a push-on connective element for attachment to inner graduatedsurfaces2443 of thespacer2415 and slidable connection to an inner surface of thespacer2412. It is foreseen that thespacer2412 may include graduated surfaces to provide for a fixed or press fit connection between thesleeve2407 and thespacer2412.
• Thebumper2417 is substantially cylindrical and tubular in form, having an outer cylindrical surface and an inner, graduated through bore. Thebumper2417 has opposed substantially planar annular end surfaces. An inner cylindrical surface of the bore is sized and shaped to closely receive a tubular extension of thecord blocker2418. Thebumper2417 is elastic and may be made from a variety of compressible and stretchable materials, including, but not limited to natural or synthetic elastomers such as polyisoprene (natural rubber), and synthetic polymers, copolymers, and thermoplastic elastomers, for example, polyurethane elastomers such as polycarbonate-urethane elastomers. In order to have low or no wear debris, the bumper inner surface may also be coated with an ultra thin, ultra hard, ultra slick and ultra smooth coating, such as may be obtained from ion bonding techniques and/or other gas or chemical treatments.
• With reference toFIGS. 97,113 and114, thecord blocker2418 and cooperatingset screw2419 are shown. Theblocker2418 includes abody portion2469 and atubular extension2470 sized and shaped to be slidingly received in thebumper2417. The illustratedbody portion2469 andtubular extension2470 are integral or otherwise fixed to one another. A throughbore2474 extends through a lower portion of thebody portion2469 and centrally through thetubular extension2470. Thebore2474 is sized and shaped to receive thecord2422 and when assembled with a remainder of theassembly2401 extends along the axis F. Formed in thebody portion2469 is a threadedbore2475 sized and shaped to receive and threadably mate with a thread of theset screw2419. The threadedbore2475 communicates with the throughbore2474 and is substantially perpendicular thereto. Asurface2476 partially defining thebore2474 includes adepression2477, sized and shaped for receiving thecord2422 therein when theset screw2419 engages thecord2422. Thesleeves2405,2406 and2407 also include such a depression for receiving thecord2422 within bores thereof when thegrip closure top2431 is used to clamp thecord2422 within the sleeve without damaging or destroying thecord2422.
• It is noted that theblocker2418 and setscrew2419 combination is typically provided with thebumper2417 pre-attached thereto and handled as a unit assembly. Thus, prior to being received by the surgeon, thebumper2417 is wedged and in some cases adhered or otherwise fixed onto the tubular extension at the factory, with the inner surface of the bumper frictionally engaging thesurface2470 of theblocker2418 and thebumper2417 abutting against and fixed to theblocker body2469.
• With reference toFIGS. 97,111 and112, the cord/rod coupler2424 is shown. Thecoupler2424 includes a centrally located cylindrical body portion2479 atubular extension2480 having aninner thread2481 for mating with athread2482 of a hard surfacedrod2425 and aknob feature2483 sized and shaped for press fit engagement with thespacer2412. Acentral bore2485 extends through the knob, body and tubular extension, thethread2481 partially defining thebore2485. Thebore2485 is sized and shaped to receive thecord2422 and when assembled with a remainder of theassembly2401 extends along the axis F. Formed in thebody portion2479 is arecess2486 sized and shaped to hold an end knot orknob2488 of thecord2422 therein, thebore2485 located at the knobbedcoupler end2483 being of smaller diameter than a remainder of thebore2485 and thus forming a restriction, prohibiting movement of the cord knot orknob2488 from passing into thebore2485 at theknobbed end2483.
• With particular reference toFIG. 97, the illustratedcord2422 includes an elongate body2490 with an enlargement shown in the form of a knot orknob2488 at one end thereof and an opposed cut-to-length end2494. Theenlarged end2488 may be created by heating thecord2422 to melt the cord and create such feature that is slidable through the threadedportion2481 of the cord/rod coupler2424 but is otherwise captured within therecess2486 of thecoupler2424 and is too large to enter thebore2485 at the knobbedportion2483 of thecoupler2424. Alternatively a pin may be fixed to thecord2422. In other embodiments of the invention that do not include a rod/cord coupler2424, a blocker and set screw combination, similar to theblocker2418 and setscrew2419 may be used to fix thecord2422 outside of thesleeve2407 and/orspacer2412. Thecord2422 may be made from a variety of materials, including polyester or other plastic fibers, strands or threads, such as polyethylene-terephthalate. A cord according to the invention typically does not illustrate elastic properties, such as any significant additional axial distraction and lengthening after theassembly2401 is operatively assembled and the cord is tensioned. However, it is foreseen that in some embodiments, thecord2422 may be made of an elastic or semi-elastic material, such as a plastic or rubber (natural or synthetic) having at least some elastic properties, allowing for some further distraction of theassembly2401 during operation thereof. The core can also be a cable-like structure made of metal.
• With reference toFIGS. 117-122, various closure tops for use with thebone screw assemblies2001 and the connectingassembly2401 are shown. Thebone screw2432 shown inFIGS. 121 and 122 includes a break-off head designed to allow such a head to break from a base of the closure at a preselected torque, for example, 70 to 140 inch pounds. Theclosure structure2432 includes an outer helically wound guide andadvancement structure2502, atop surface2504 of the guide and advancement structure, aninternal drive2506, abottom surface2508, apoint2509 and arim2510. Other than the break-off head, theclosure2432 is substantially the same as, for example, theclosure top210 described above with respect to theassembly1 andbone screw25. Located above the guide and advancement structure top surface is a break-offhead2512. As shown inFIG. 99, the closure tops2432 engage and penetrate thehard rod portion2425 of theconnector2401.
• With reference toFIGS. 99 and 117 and118, also cooperating with the bone anchors2001 is theclosure top2431 having an outer helically wound guide andadvancement structure2522, atop surface2524 of the guide and advancement structure, aninternal drive2526 and a break-offhead2532, the same or similar to the respective guide andadvancement structure2502,top surface2504,internal drive2506 and break-offhead2512 previously discussed herein with respect to theclosure top2432. In lieu of the point and rim of theclosure top2432, theclosure top2431 has a lowercylindrical portion2527 having a substantiallyplanar bottom surface2528. Theportion2527 is sized and shaped to be received by thebore2441,2451 or2461 ofrespective sleeves2405,2406 and2407, thebottom surface2528 pressing thecord2422 into fixed engagement with the sleeve.
• With reference toFIGS. 99 and 119 and120, also cooperating with the bone anchors2001 is theclosure top2430 having a an outer helically wound guide andadvancement structure2542, atop surface2544 of the guide and advancement structure, aninternal drive2546 and a break-offhead2552, the same or similar to the respective guide andadvancement structure2522,top surface2524,internal drive2526 and break-offhead2532 previously discussed herein with respect to theclosure top2431. Theclosure top2430 includes aplanar bottom surface2548 adjacent the guide andadvancement structure2542. As illustrated inFIGS. 98 and 99, theplanar bottom surface2548 remains flush with a corresponding sleeve surface and does not enter into thebore2441,2451 or2461, allowing sliding movement of thecord2422 with respect to thebone screw receivers2010 cooperating with the closure tops2430.
• Theassembly2401 may be assembled as follows: First, after the bone screws2001 are implanted, the distance between the screws is measured. Thereafter, the spacer/liner combinations2410 and2411 are cut to a desired length based upon the measurement made between the bone screws. A tool (not shown), similar to a pipe cutter is usually used to rotate and cut the spacer/liner combination to the desired length at an end opposite the graduated surfaces of the respective spacer. Also at this time, in view of the resulting spacer/liner length, cooperatingsleeves2405 and2406 of desired sizes are chosen. Because the sleeves are made from a hard material, typically a metal or metal alloy, it is not practical to cut the tube portions thereof to a desired length during the surgical procedure. Therefore, a variety ofsleeves2406 and2407 are typically provided to end users having at least three different tube portion lengths.
• With particular reference toFIG. 97, thecord2422 is first slid into thecoupler2424 with theend2494 being placed within the coupler at the threadedend2481, thecord2422 being fed therethrough until theknobbed end2488 of the cord is captured within thecoupler recess2486. Therod2425 threadedend2482 may be mated with thecoupler thread2481 at this time or at the very end of the procedure. Thecord2422 is then successively threaded through the connector elements as shown by the arrow G inFIG. 97, some of the components, such as thespacer liner combinations2410 and2411 and the blocker/bumper2418/2417 having been previously assembled. With reference toFIG. 99, as thecord2422 is threaded into the assembly elements, the spacer/liner combinations2410 and2411 and thespacer2412 are placed into position covering or overlapping tubular portions of thesleeves2405,2406 and2407. Thecord2422 is typically much longer than shown inFIGS. 97 and 99 and then cut to length near theend2494 after being fully assembled with the remaining elements of theassembly2401, so that the cord may be grasped and tensioned either before or after theassembly2401 is fixed to the bone screws2001. If pre-tensioning is desired, at this time, prior to implanting the assembly, a tensioning tool (not shown) known in the art is used to pull upon and put tension on thecord2422 near theend2494. Thecord2422 is preferably tensioned until the bumper compresses and then theset screw2419 is rotated and driven into theblocker2418 and up against thecord2422 using a driving tool (not shown) engaged with an inner drive of theset screw2419.
• The assembly2401 (either pre-tensioned or in a loosely attached orientation) is implanted by inserting the sleeve body portions into the bone screws2001 with eachreceiver2010 being received between the two flanges of each sleeve. Closure tops2430 and2431 are chosen by the surgeon based upon whether a sliding or a gripping relationship is desired with theparticular receiver2010.
• With reference toFIG. 99, the finaltensioned assembly2401 is shown that is substantially dynamically loaded and oriented relative to the cooperating vertebra, providing relief (e.g., shock absorption) and protected movement with respect to flexion, extension, distraction and compressive forces placed on theassembly2401 and theconnected bone screws2001 as well as providing more rigid support at therod2425. During complex spinal movements, thespacers2412,2413 and2415 are able to move or flex away from and towards the flanges of thesleeves2405,2406 and407 without compromising the strength and integrity of theassembly2401. It is noted that a problem encountered with dynamic spinal implant systems is the need to provide adequate support with respect to bending sheer. Most spinal movements are not purely bending movements, e.g., flexion and extension. Most movements include both bending and tension, extension or compression. Such bending shear is not well resisted by a cord and spacer alone that performs well in tension, but not when the tension includes a vector force. The present invention advantageously provides a hard, non-elastic extension of a rigid sliding sleeve body, the extension further located within an optional non-elastic liner of thespacer2413 or2415. Such features protect against vector forces while still allowing for advantageous tension of thecord2422 as well as improved compression provided by theouter bumper2417. Thecord2422 and thesleeves2405,2406 and2407 allow for some twisting or turning, providing some relief for torsional stresses. Furthermore, thecompressed bumper2417 and the fixed contact between the sleeves and one end of each spacer, as well as the fixed contact between thebumper2417 and theblocker2418 places some limits on torsional movement as well as bending movement, to provide spinal support. The cord2422 (in tension) and bumper2417 (in compression) allow for compression and some extension of theassembly2401 located between the twobone screws2001, e.g., shock absorption. Another advantage of embodiments of the present invention is that because of the inelastic sleeve extension that slides within and is overlapped by the typically elastic spacer located between two bone screws, the resultingassembly2401 is more stable than a cord and spacer alone, therefore strength of the assembly does not rely solely upon the amount of tension placed upon the cord. Therefore, in embodiments according to the invention, it is not necessary to place as much tension on thecord2422 as would be required for a more traditional cord and spacer arrangement, thus protecting the cord from damage of over stressing.
• If removal of theassembly2401 from any of thebone screw assemblies2001 is necessary, or if it is desired to release theassembly2401 at a particular location, disassembly is accomplished by using the driving tool (not shown) with a driving formation cooperating with internal drives of theclosure structures2430,2431 and2432 to rotate and remove such closures from thereceivers2010. Disassembly is then accomplished in reverse order to the procedure described previously herein for assembly.
• Eventually, if the spine requires more rigid support, the connectingmember assembly2401 according to the invention may be removed and replaced with another longitudinal connecting member, such as a solid rod or bar, having the same width or diameter as body portions of thesleeves2405,2406 and2407, utilizing thesame receivers2010 and theclosure structures2432. Alternatively, if less support is eventually required, a less rigid, more flexible assembly, for example, anassembly2401 having spacers and bumpers made of a softer more compressible material than the spacers and bumpers being replaced thereby, also utilizing the same bone screws2001.
• With reference toFIGS. 115-116, an alternative longitudinal connecting member assembly according to the invention, generally2401′ is illustrated wherein thesleeve2407 is replaced by asleeve2406′ that is the same as thesleeve2406 with the exception that theknobbed end portion2462 that provides a push-on fixed element attachment is replaced by a cylindrical extension slidingly received within thespacer2412, illustrating one of the many segmental stiffness choices available to a surgeon with assemblies according to the invention.
• With reference toFIGS. 123-139 further alternative connecting members according to the invention are shown that include one or more sleeves with cooperating, spacers, bumpers and an inner tensioned cord, such as, for example, the connecting member, generally3201, shown inFIG. 133. With particular reference toFIGS. 123-131, abone screw3001 is illustrated with a hard, inelastic, flanged sleeve, generally3204 through which a tensionedcord3206 extends. Thecord3206 is not shown inFIGS. 123-131, but see, for example,FIG. 133, that also illustrates a cooperating cord blocker orfixer3210 with a cord fixingset screw3212, anelastic end bumper3214, and elastic orinelastic spacers3216 that are each located about thecord3206 and are disposed between each pair of bone anchors3001 of theoverall assembly3201. Theassembly3201 is assembled in the same or similar manner as described above with respect to theassemblies1 and2401, for example. Thetubular bumper3214 andtubular spacers3216 shown inFIG. 133 are transparent, allowing for viewing of the sleeves, generally3204, and the tensionedcord3206 inFIG. 133. However, it is foreseen that in other embodiments, thespacers3216 may be made of materials that may not be transparent or translucent. Also as shown inFIG. 133, at least two types of bone screw closures are utilized, either a slide or slipping closure top3018 or3018′ or a cord gripping closure top3018″. The tops3018 and3018′ are substantially identical to the closure top210 previously described herein, with the top3018′ further including a point and rim. The closure top3018″ is similar to the tops3018 and3018′, but rather than a point and rim, the top3018′ includes acord penetrating extension3171. The slide or slip closure tops3018 and3018′ engage arespective sleeve3204 but not thecord3206, allowing the cord to slip or slide within thepolyaxial screw3001. The grip closure top3018″ extends through the sleeve and grips and fixes thecord3206 with respect to the sleeve and thus fixes the cord in relation to thepolyaxial screw3001. The illustratedextension3171 penetrates thecord3206 and extends into a lower aperture of the respective sleeve. Also, tubular extensions of some of thesleeves3204 extend into and through some of thespacers3216. Such spacer overlap with respect to the sleeves provides advantageous anti-shear support for the connectingmember3201. A portion of thecord blocker3210 also extends into a bore of thebumper3214. Thebumper3214 also extends about thecord3206 and is typically made from an elastomer while theouter spacers3216, although typically elastomeric, may be made from a material with a different durometer, typically (but not always) being tougher and less compressible than the material of thebumper3214. Thesleeves3204 and thespacers3216 are typically made from a hard, non-elastic material, such as a metal or metal alloy, like cobalt chromium. Flanged portions of thesleeves3204 are located on either side of thebone screw receivers3010, the flanges abutting against thespacers3216 or thebumper3214, the flanges extending radially outwardly to an extent to fully engage ends of adjacent spacers or the bumper, resulting in a stable, secure, substantially full contact between the individual elements of theassembly3201. Furthermore, the flanges allow for assembly and dynamic setting of theconnector3201 prior to implantation, if desired, with thecord3206 being placed in tension and at least thebumper3214 being placed in compression. In some embodiments of the invention, tensioning of thecord3216 and compression of thebumper3214 and optionally thespacers3216 may be performed after theassembly3201 is attached to the bone screws3001.
• With particular reference toFIGS. 123-129, abone screw assembly3001 is illustrated with aparticular sleeve3204D. With reference toFIG. 129, thebone screw3001 generally includes ashank3004, areceiver3010, anopen retainer3012 for capturing a shankupper portion3008 in thereceiver3010, aninsert3014 having a planar top surface, aspring ring3016 for holding theinsert3014 during some of the steps of assembly of the bone screw, and shown with the closure top3018′. Although a particular bone screw is shown, thesleeves3204 may be utilized with a variety of bone screws, particularly those with inserts such as theinsert3014 having a low profile with either a planar top surface (or a slightly recessed surface), providing adequate space within the receiver for receiving both theinsert3014 at a lower portion thereof and onesleeve3204 at an upper portion thereof, allowing for a larger or more substantial sleeve than, for example, bone screws having an insert with a U-shaped recess and arm portions that extend upwardly on either side of the sleeve wherein the insert arms and/or the sleeve would both be required to be relatively narrow or thin to both fit between the receiver arms.
• Sleeves3204 of the invention are provided with or without tubular extensions, on one or both sides thereof, and with different lengths of tubular extensions, as best shown inFIG. 132. Thus, eachdifferent sleeve3204 configuration has been further identified with a letter to indicate the type of extension, withFIG. 132 illustratingsleeves3204A through3204L.FIG. 132 also illustrates asleeve3204M that is a rod/cord coupler and is further illustrated inFIGS. 134-136 and will be described in greater detail below.
• Thesleeves3204A-33204F are identical with the exception of the presence or length of one or more tubular extension. Therefore, thesleeve3204D will be the only sleeve of this group discussed in detail herein with particular reference toFIGS. 123-129.
• Thesleeve3204D further includes a body portion3234 generally sized and shaped for being received within thepolyaxial bone screw3001receiver3010 and a pair of opposedtubular extensions3235 sized and shaped to be slidingly received within thespacer3216 and over thecord3206. The illustrated body portion3234 andtubular extensions3235 are integral or otherwise fixed to one another. A throughbore3236 extends centrally through the body portion3234 and centrally through thetubular extensions3235. Thebore3236 is sized and shaped to slidingly receive thecord3206. The body portion3234 further includes a pair of spaced radially extendingflanges3237 and3238 with a partially cylindrical and partially planar body portion being located therebetween, the body portion having a slightly enlarged or protruding portion or portions illustrated as opposed partially cylindrical and partiallyplanar extensions3239, sized and shaped to closely fit within the cylindrical inner arm surfaces of thebone screw receiver3010. Theportions3239 function to center the sleeve within thebone screw receiver3010 and also advantageously strengthen the sleeve, resulting in better load transfer. It is foreseen that in some embodiments of the invention, the body3234 with centeringstructure3239 may be configured to also extend down into the receiver and abut the bone screw shankupper portion3008 and thus eliminate thecompression insert3014. Furthermore, in some embodiments, theflanges3237 and3238 may be reduced or eliminated as the centering of the sleeve with respect to thebone screw receiver3010 may be performed by the portion orportions3239.
• In the illustrated embodiment, theflanges3237 and3238 are substantially cylindrical having opposed planar and annular side surfaces spaced for closely receiving thebone screw3001receiver3010. The illustratedflanges3237 and3238 include a lower cut-out, allowing for a close fit betweeninner flange surfaces3240 and the planar receiver base surfaces3069. Thebody portion3239 may be sized and shaped to be receivable within and frictionally fixed to a variety of monoaxial or polyaxial screw heads or receivers, including thereceiver3010. Abore3241 is formed in the body3234 between theflanges3237 and3238, thebore3241 transverse to and communicating with the throughbore3236. Thebore3241 is sized and shaped to receive the closure top3018″ therein for frictionally gripping thecord3206, theextension3171 penetrating thecord3206 and extending near or into anaperture32418 located in the sleeve opposite the opening of thebore3241 and thus placing thecord3206 in fixed relation with thebone screw receiver3010, if desired.
• The sleeves generally3204, as well as thecord blocker3210 withset screw3212 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• With reference toFIGS. 130-132,lordotic sleeves3204G-3204L are also shown. Thesleeves3204G-3204L are identical to thesleeves3204A-3204F, respectively, with the exception that flanges3237′ and3238′ are provided that slope at an angle, inwardly towards thebone screw receiver3010 as best shown inFIG. 131 (that illustrates the use of thesleeve3204J) and also in theassembly3201 shown inFIG. 133 that illustrates the use of a plurality of lordotic sleeves.
• With reference toFIG. 132 andFIGS. 134-136, the sleeve and rod/cord coupler3204M includes a sleeve body portion3234′, onetubular extension3235′, asingle flange3238″ and a partial throughbore3236′ substantially similar to the respective sleeve body3234,tubular extensions3235,flanges3238 and throughbore3236 of theother sleeves3204A-3204F. At an end opposed to thetubular extension3235′, the body portion3234′ is integral with an elongatesolid rod portion3250. Also, formed in the body portion3234′ is an aperture or throughbore3251 transverse to and communicating with thebore3236′, the throughbore3251 sized and shaped to closely receive acord holding pin3252. Thepin3252, if used, extends completely through thecord3206, independently fixing thecord3206 to thesleeve3204M. Alternatively, in some embodiments of the invention, thepin3252 is not used and a closure top3018″ may be inserted within abore3241′ of the sleeve/coupler3204M to fix thecord3206 to thesleeve3204M. In the illustrated embodiment, thebores3241′ and3251 are substantially parallel to one another. Therod portion3250 may be provided in a variety of lengths (or cut to length) to cooperate with one or more bone screws to provide a rigid support end to a dynamic assembly, such as theassembly3201 shown inFIG. 133.
• With reference toFIGS. 137-139, a set of alternative sleeves, generally3304, are shown that are substantially similar to thesleeves3204 previously described herein, with the exception of surface features3345 that allows for a press or friction fit with thereceiver3010. Therefore, the sleeves3304 each include asleeve body3334, two, one or no tubular extensions3335, a throughbore3336, a pair offlanges3337 and3338, a partiallycylindrical body portion3339,inner flange surfaces3340 and avertical bore3341 that are the same or similar to the respective sleeve body3234,tubular extensions3235, throughbore3236, pair offlanges3237 and3238, partiallycylindrical body portion3239,inner flange surfaces3240 andvertical bore3241 of the sleeves, generally3204 previously described herein. The pair of opposed press fit surface features3345 are located on either side of thecylindrical portion3339 and in operation are disposed between the receiver arms at or near a run-out of the guide and advancement structure for the closure top and a discontinuouscylindrical surface3086. As the sleeve3304 is pressed downwardly toward the receiver base, thesurfaces3345 engage thesurface3086, providing a snug, but adjustable fit between the sleeve3304 and the receiver arms.
• With reference toFIGS. 140-154 apolyaxial bone screw4001 that does not include a pressure insert is shown being used in a connectingmember4201 that includes another embodiment of a sleeve, generally4204, according the invention. The connectingmember4201 includes one or more sleeves, generally4204 with cooperating, spacers, bumpers and an inner tensioned cord, such as, for example, shown inFIG. 154. The illustratedbone screw4001 generally includes ashank4004, anopen retainer4012, areceiver4010 and is shown inFIG. 140 with a slip or slideclosure top4018 and a gripping closure top4018′ as well as one of thesleeves4204. Thesleeves4204 are hard, inelastic and flanged, through which a tensionedcord4206 extends as shown inFIG. 154.FIG. 154 also illustrates a cooperating cord blocker orfixer4210 with a cord fixingset screw4212, anelastic end bumper4214, and elastic orinelastic spacers4216 that are each located about thecord4206 and are disposed between each pair of bone anchors4001 of theoverall assembly4201. Thetubular bumper4214 andtubular spacers4216 shown inFIG. 154 are transparent, allowing for viewing of the sleeves, generally4204, and the tensionedcord4206 inFIG. 154. However, it is foreseen that in other embodiments, thespacers4216 may be made of materials that may not be transparent or translucent. Also as shown inFIG. 154, two types of bone screw closures are utilized, either the slide or slipping closure top4018 previously described herein (e.g.,closure2432 of theassembly2401 orclosure3018′ of the assembly3201) or a cord gripping closure top4018′ similar to the top2431 of theassembly2401. The slide or slipclosure top4018 engages arespective sleeve4204 but not thecord4206, allowing the cord to slip or slide within thepolyaxial screw4001. The grip closure top4018′ extends through the sleeve and grips and fixes the cord40206 against a surface of the sleeve and thus fixes the cord in relation to thepolyaxial screw4001. Tubular extensions of some of thesleeves4204 may extend into and through some of thespacers4216. Such spacer overlap with respect to the sleeves provides advantageous anti-shear support for the connectingmember4201. A portion of thecord blocker4210 also extends into a bore of thebumper4214. Thebumper4214 also extends about thecord4206 and is typically made from an elastomer while theouter spacers4216, although typically elastomeric, may be made from a material with a different durometer, typically (but not always) being tougher and less compressible than the material of thebumper4214. Thesleeves4204 and thespacers4216 are typically made from a hard, non-elastic material, such as a metal or metal alloy, like cobalt chromium. Flanged portions of thesleeves4204 are located on either side of thebone screw receivers4010, the flanges abutting against thespacers4216 or thebumper4214, the flanges extending radially outwardly to an extent to fully engage ends of adjacent spacers or the bumper, resulting in a stable, secure, substantially full contact between the individual elements of theassembly4201. Furthermore, the flanges allow for assembly and dynamic setting of theconnector4201 prior to implantation, if desired, with thecord4206 being placed in tension and at least thebumper4214 being placed in compression. In some embodiments of the invention, tensioning of thecord4216 and compression of thebumper4214 and optionally thespacers4216 may be performed after theassembly4201 is attached to the bone screws4001.
• With particular reference toFIG. 141, three different types ofsleeves4204, shown without tubular extensions, are illustrated. They are a parallelflanged sleeve4204A, an angled orlordotic sleeve4204B and atransition sleeve4204C that includes a rod/cord coupler. As stated above,sleeves4204 of the invention may be provided with or without tubular extensions, on one or both sides thereof, and with different lengths of tubular extensions, as best shown inFIG. 154. Thesleeves4204A shown inFIG. 154 may include anextension4800 on one side thereof, pairs of substantiallyidentical extensions4810 or4820, or for example, opposingextensions4830 and4831 of different lengths, to name a few. The illustrated sleeve with rod/cord coupler4204C also includes atubular extension4840.
• With particular reference toFIGS. 142-147, thebone screw assembly4001 is illustrated with thesleeve4204A. Thesleeve4204A further includes abody portion4234 generally sized and shaped for being received within thepolyaxial bone screw4001receiver4010 and about thecord4206. A throughbore4236 extends centrally through thebody portion4234, thebore4236 being sized and shaped to slidingly receive thecord4206. Thebody portion4234 further includes a pair of spaced radially extendingflanges4237 and4238 with a partially cylindrical and partially planar body portion being located therebetween, the body portion having a slightly enlarged or protruding portion or portions illustrated as opposed faceted or partially cylindrical and partiallyplanar extensions4239, sized and shaped to closely fit within the cylindrical inner arm surfaces of thebone screw receiver4010. Theportions4239 function to center the sleeve within thebone screw receiver4010 and also advantageously strengthen the sleeve, resulting in better load transfer. Thebody4234 with centeringstructure4239 further includes abottom surface4240 having a roughened or as illustrated, textured surface with ridges orpoints4241 configured to abut against, engage and penetrate thedomed surface4040 of the shank upper portion4008 as best shown inFIG. 146. Thesurface portion4241 may also be cupped or radiused without spikes or ridges.
• It is foreseen that in some embodiments, theflanges4237 and4238 may be reduced or eliminated as the centering of the sleeve with respect to thebone screw receiver4010 may be performed by the portion orportions4239. In the illustrated embodiment, theflanges4237 and4238 are substantially cylindrical having opposed planar andannular side surfaces4242 spaced for closely receiving thebone screw4001receiver4010. The illustratedflanges4237 and4238 include a lower cut-out, allowing for a close fit betweeninner flange surfaces4242 and the receiver base surfaces. Thebody portion4239 may be sized and shaped to be receivable within and frictionally fixed to a variety of monoaxial or polyaxial screw heads or receivers, including thereceiver4010. Thebody portion4239 may also be configured to provide a lock and release feature as previously discussed herein with respect to the sleeves3304 shown inFIG. 137, for example. Abore4243 is formed in thebody4234 between theflanges4237 and4238, thebore4243 transverse to and communicating with the throughbore4236. Thebore4243 is sized and shaped to receive the closure top4018 or4018′ therein. As illustrated inFIG. 147, the closure top4018′ is inserted in thesleeve4204A with theextension4169′ extending into thesleeve4204A for frictionally gripping a cord4206 (not shown) against an internal surface defining the throughbore4236, and thus placingsuch cord4206 in fixed relation with thebone screw receiver4010, if desired.
• The sleeves, generally4204, as well as thecord blocker4210 withset screw4212 may be made from a variety of inelastic materials, including, but not limited to metals, metal alloys, including cobalt chromium, and inelastic plastics including, but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber and layers of different materials.
• With reference to FIGS.141 and148-150, thelordotic sleeve4204B is illustrated. Thesleeve4204B is identical to thesleeve4204A with the exception that flanges4237′ and4238′ are provided that slope at an angle, inwardly towards thebone screw receiver4010 as best shown inFIG. 148.
• With reference toFIG. 141 andFIGS. 151-153, the sleeve and rod/cord coupler4204C includes asleeve body portion4234″, asingle flange4238″ and a partial throughbore4236″ substantially similar to therespective sleeve body4234,flange4238 and throughbore4236 of thesleeve4204A. At an end opposed to theflange4238″, thebody portion4234″ is integral with an elongatesolid rod portion4250. Also, formed in thebody portion4234″ is an aperture or throughbore4251 transverse to and communicating with thebore4236″, the throughbore4251 sized and shaped to closely receive acord holding pin4252. Thepin4252, if used, extends completely through thecord4206, independently fixing thecord4206 to thesleeve4204C. Alternatively, in some embodiments of the invention, thepin4252 is not used and a closure top4018′ may be inserted within abore4243″ of the sleeve/coupler4204C to fix thecord4206 to thesleeve4204C. In the illustrated embodiment, thebores4243″ and4251 are substantially parallel to one another. Therod portion4250 may be provided in a variety of lengths (or cut to length) to cooperate with one or more bone screws to provide a rigid support end to a dynamic assembly, such as theassembly4201 shown inFIG. 154.
• It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.

Claims (24)

1. In a medical implant assembly having at least first and second bone anchors cooperating with a longitudinal connecting member having a tensioned cord, the bone anchors having opposed upstanding arms, the improvement comprising:

a) a first non-elastic sleeve for attachment to the first bone anchor, the first sleeve having a first through bore sized and shaped for slidably receiving the tensioned cord, a first aperture formed in the sleeve substantially transverse to the through bore, the aperture sized and shaped for receiving a portion of a first optional cord gripping closure top and a first body portion sized and shaped for being closely received between the bone anchor arms;

b) a second non-elastic sleeve for attachment to the second bone anchor, the second sleeve having a second through bore sized and shaped for slidably receiving the tensioned cord, a second aperture formed in the sleeve substantially transverse to the second through bore, the second aperture sized and shaped for receiving a portion of a second optional cord gripping closure top and a second body portion sized and shaped for being closely received between the second bone anchor arms; and

c) a spacer located between the first and second bone anchors, the spacer engaging each of the first and second sleeves, the cord extending through the spacer and held in tension at least first and second ends of the connecting member.

2. The improvement ofclaim 1 comprising at least a first closure top having an extended portion in gripping contact with the cord and fixed to one of the first and second sleeves.

3. The improvement ofclaim 1 comprising at least a second closure top having a surface in gripping contact with one of the first and second sleeves, the closure top being spaced from the cord.

4. The improvement ofclaim 1 wherein at least one of the first and second sleeves includes an extension slidingly received within the spacer.

5. The improvement ofclaim 4 further comprising a hard inner liner disposed between the extension and the spacer.

6. The improvement ofclaim 1 wherein at least one of the first and second sleeves includes an outer flange abutting against an outer surface of the spacer.

7. The improvement ofclaim 6 wherein the outer flange is a first outer flange and further comprising a second outer flange substantially parallel to the first outer flange, each flange being disposed outside of the bone anchor.

8. The improvement ofclaim 7 further comprising at least one tubular structure extending outwardly from at least one of the flanges.

9. The improvement ofclaim 6 wherein the outer flange is a first outer flange and further comprising a second outer flange disposed at an obtuse angle with respect to the first outer flange, each flange being disposed outside of the bone anchor.

10. The improvement ofclaim 9 further comprising at least one tubular structure extending outwardly from at least one of the flanges.

11. The improvement ofclaim 1 wherein at least one of the first and second sleeves has an outer surface flush with an outer surface of the bone anchor.

12. The improvement ofclaim 1 wherein at least one of the first and second sleeves has a first U-shaped lower surface sized and shaped to frictionally engage a second U-shaped surface of a pressure insert located within the bone anchor.

13. The improvement ofclaim 1 wherein at least one of the first and second sleeves has a first planar surface in frictional engagement with a second planar surface of a pressure insert located within the bone anchor.

14. The improvement ofclaim 1 wherein the bone anchor is a polyaxial bone screw having a shank pivotable with respect to a receiver, at least one of the first and second sleeves being held within the receiver and directly engaging the shank.

15. In a medical implant assembly having at least first and second bone anchors cooperating with a longitudinal connecting member, the improvement wherein the connecting member comprises:

a) a first non-elastic sleeve for attachment to the first bone anchor, the first sleeve having at least a first extension;

b) a second non-elastic sleeve for attachment to the second bone anchor;

c) a spacer located between the first and second bone anchors, the spacer engaging the first and second sleeves, the spacer received over the first extension and being movable with respect thereto; and

d) a tensioned cord slidingly received within the first and second sleeves and the spacer, the cord being in one of a fixed and slidable relation with respect to the first and second sleeves.

16. The improvement ofclaim 15 wherein at least one of the sleeves has an aperture formed therein sized and shaped to receive a portion of a closure top, the closure top portion being fixed against the cord.

17. The improvement ofclaim 15 further comprising a hard liner disposed between the first extension and the spacer, the first extension being in slidable relation with the hard liner, the liner being in fixed relation with the spacer.

18. In a surgical method for implanting a tensioned cord between at least first and second implanted bone anchors with a spacer disposed between the bone anchors, the bone anchors having opposed upstanding arms, the improvement comprising:

a) providing a first non-elastic sleeve for attachment to the first bone anchor, the first sleeve having a first through bore sized and shaped for slidably receiving the cord, a first aperture formed in the sleeve substantially transverse to the through bore, the aperture sized and shaped for receiving a portion of a first optional cord gripping closure top and a first body portion sized and shaped for being closely received between the bone anchor arms;

b) providing a second non-elastic sleeve for attachment to the second bone anchor, the second sleeve having a second through bore sized and shaped for slidably receiving the cord, a second aperture formed in the sleeve substantially transverse to the second through bore, the second aperture sized and shaped for receiving a portion of a second optional cord gripping closure top and a second body portion sized and shaped for being closely received between the second bone anchor arms;

c) loading the first sleeve on the cord, followed by the spacer, followed by the second sleeve;

d) inserting the first sleeve in the first bone anchor and the second sleeve in the second bone anchor;

e) tensioning the cord and fixing the cord at each end of the connector;

f) optionally fixing the cord to one of the first and second bone anchors by inserting a closure top through one of the first and second sleeves into engagement with the cord; and

g) optionally allowing the cord to slip with respect to one of the first and second bone anchors by inserting a closure top into one of the first and second bone anchors, the closure top having an end surface that remains spaced from the sleeve aperture.

19. In a medical implant assembly having at least first and second bone anchors cooperating with a longitudinal connecting member having a tensioned cord, the improvement comprising:

a) at least one non-elastic sleeve for attachment to the first bone anchor, the sleeve having a body portion sized and shaped for being closely received between opposed arms of the first bone anchor;

b) a spacer located between the first and second bone anchors, the cord extending through the spacer and held in tension at least first and second ends of the connecting member; and

c) at least one blocker, the first bone anchor being located between the blocker and the spacer, the blocker located near the sleeve, the blocker being fixed to the tensioned cord.

20. The improvement ofclaim 19 wherein the blocker is adjacent the first bone anchor.

21. The improvement ofclaim 19 wherein the blocker engages the sleeve.

22. The improvement ofclaim 19 further comprising a bumper located between the blocker and the first bone anchor.

23. The improvement ofclaim 19 wherein the second bone anchor is a monoaxial bone screw fixed to the cord.

24. The improvement ofclaim 19 wherein the at least one sleeve is a first sleeve and further comprising a second sleeve, the second sleeve for attachment to the second bone anchor.

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