DYNAMIC SPINAL STABILIZATION WITH ROD-CORD LONGITUDINAL CONNECTING MEMBERS

Abstract

A dynamic fixation medical implant having at least two bone anchors includes a longitudinal connecting member assembly having at least one transition portion and cooperating outer sleeve, both the transition portion and sleeve being disposed between the two bone anchors. In a first embodiment, the transition portion includes a rigid length or rod having apertures therein for tying or otherwise attaching the rigid length to a second rigid length or to a flexible cord. Slender ties or cords extend through a plurality of apertures in the rigid lengths or are threaded, tied or plaited to the larger flexible cord or cable. In a second embodiment, a transition portion includes slender ties of a cord that are imbedded in a molded plastic of a more rigid member. The outer sleeve may include compression grooves. The sleeve surrounds the transition portion and extends between the pair of bone anchors, the sleeve being compressible in a longitudinal direction between the bone anchors.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 16/677,981, filed Nov. 8, 2019, which is a continuation of U.S. application Ser. No. 13/896,439, filed May 17, 2013, now U.S. Pat. No. 10,470,801, which is a continuation of U.S. application Ser. No. 12/006,460, filed Jan. 3, 2008, now U.S. Pat. No. 8,475,498, which claimed the benefit of U.S. Provisional Application No. 60/922,465 filed Apr. 9, 2007; U.S. Provisional Application No. 60/898,870, filed Feb. 1, 2007; and U.S. Provisional Application No. 60/880,969, filed Jan. 18, 2007, each of which is incorporated by reference in its entirety herein, and for all purposes.

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 for such assemblies, the connecting members being attached to at least two bone fasteners.

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 flexure, extension, torsion, 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 rigid support in all planes.

Fusion, however, has some undesirable side effects. One apparent side effect is the immobilization of a portion of the spine. Furthermore, although fusion may result in a strengthened portion of the spine, it also has been linked to more rapid degeneration due to increased stresses and even hyper-mobility and collapse of spinal motion segments that are adjacent to the portion of the spine being fused, reducing or eliminating the ability of such spinal joints to move in a more normal relation to one another. In certain instances, fusion has also failed to provide pain relief.

An alternative to fusion 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 inflexion, extension, distraction, compression, side bending and torsion. Problems may arise with such devices, however, including tissue scarring, lack of adequate spinal support and lack of fatigue strength or endurance limit. Fatigue strength has been defined as the repeated loading and unloading of a specific stress on a material structure until it fails. Fatigue strength can be tensile or distraction, compression, shear, torsion, bending, or a combination of these.

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 and in contact with adjacent bone anchors when such a cord or strand is implanted, tensioned and attached to or compressed against the bone anchors. The spacers typically span the distance between the bone anchors, providing limits on the bending movement of the cord or strand and thus strengthening and supporting the overall system. Such cord or strand-type systems typically require specialized bone anchors and tooling for tensioning and holding the chord or strand in the bone anchors. Thus a major disadvantage of such cord and spacer systems is their lack of interchangeability with more rigid rod systems, especially those systems that incorporate polyaxial screws as bone anchors.

The complex dynamic conditions associated with spinal movement therefore provide quite a challenge for the design of more flexible and/or elastic elongate longitudinal connecting members that exhibit an adequate fatigue strength to provide stabilization and protected motion of the spine, without fusion, and 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 with deformity correction, while another portion or length may be better supported by a more dynamic component that allows for protected movement or stress relief, especially adjacent to a long rigid rod construct. In such cases a more rigid longitudinal connecting member can be attached to a cord member of varying length.

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 longitudinal connecting member assembly according to the invention includes a transition or connection portion disposed between the bone anchors, the transition portion having at least one substantially rigid portion with at least one aperture and at least one tie, such as a slender cord, extending through the aperture. In certain embodiments, first and second rigid longitudinal connecting member portions that are each attached to a bone anchor each include a plurality of apertures. Discrete ties in the form of slender cords or strands loop through the apertures of both the first and second rigid portions, providing a flexible connection therebetween. In other embodiments, ties that are integral with or otherwise attached to a larger longitudinal connecting member cord are threaded or laced through apertures in a more rigid substantially solid longitudinal connecting member, providing a flexible transition between the flexible cord that is attached to a first bone attachment structure and a rod or other shaped longitudinal member that is attached to a second adjacent bone attachment structure. In other embodiments according to the invention, ties or strands that are integral with a flexible longitudinal connecting member cord are attached to a solid molded plastic longitudinal connecting member, the ties or strands being imbedded in the connecting member, either by placement thereof within the member during a molding process or by drilling and plugging the member with the strands with application of an adhesive, thus forming a transition portion that is substantially as rigid as a remainder of the connecting member. A plastic connecting member portion for use with the invention may range in rigidity from being quite rigid (no outer sleeve required) to being flexible (requiring an outer sleeve).

Transition portions according to the invention typically further include an outer sleeve or spacer that surrounds the transition between the cord and/or ties and the rigid portion or portions, the sleeve extending between a pair of adjacent bone anchors and in contact therewith. The transition portion and the outer sleeve cooperate dynamically, both features having some flexibility, with the outer sleeve primarily protecting and limiting flexing movement of the inner transition portion. The outer sleeve may include a grooved portion that may be compressed upon installation between two bone anchors.

A variety of embodiments according to the invention are possible. For example, both a rod-to-rod transition portion and a rod-to-cord transition portion may be included in the same longitudinal connecting member. Rods or other substantially rigid structures having different measures of rigidity may be connected according to embodiments of the invention. Either rigid lengths or flexible cords may be of greater or lesser lengths for attaching to one or a plurality of bone anchors.

OBJECTS AND ADVANTAGES OF THE INVENTION

Therefore, it is an object of the present invention to overcome one or more of the problems with bone attachment assemblies described above. An object of the invention is to provide dynamic medical implant stabilization assemblies having longitudinal connecting members that include both rigid and more flexible sections or lengths, the flexible sections allowing for at least one of bending, torsion, compression and distraction of the assembly. Another object of the invention is to provide such an assembly wherein the flexible section or sections are insertable into a protective outer sleeve. A further object of the invention is to provide such an assembly wherein the outer sleeve may be compressed upon installation. A further object of the invention is to provide dynamic medical implant longitudinal connecting members that may be utilized with a variety of bone screws, hooks and other bone anchors. Another object of the invention is to provide a more rigid or solid connecting member portion or segment, if desired, such as a solid rod portion integrally linked to one or more flexible portions or segments. Additionally, it is an object of the invention to provide a lightweight, reduced volume, low profile assembly including at least two bone anchors and a longitudinal connecting member therebetween. 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 front elevational view of a dynamic fixation longitudinal connecting member according to the invention including first and second rigid rod portions and a flexible transition/connection portion.

FIG. 2 is a front elevational view of the connecting member of FIG. 1 and further including a wound cord cover.

FIG. 3 is a front elevational view of the connecting member of FIG. 2 and further including an outer sleeve.

FIG. 4 is a perspective view of the connecting member of FIG. 3 shown with a pair of cooperating bone screws.

FIG. 5 is a front elevational view of the connecting member and bone screws of FIG. 4.

FIG. 6 is a front elevational view of a second embodiment of a dynamic fixation longitudinal connecting member according to the invention, shown with a pair of bone screws, with portions broken away to show the detail thereof.

FIG. 7 is a front elevational view of a third embodiment of a dynamic fixation longitudinal connecting member according to the invention, shown with three bone screws, with portions broken away to show the detail thereof.

FIG. 8 is a front elevational view of a fourth embodiment of a dynamic fixation longitudinal connecting member according to the invention, shown with four bone screws, with portions broken away to show the detail thereof.

FIG. 9 is a front elevational view of a fifth embodiment of a dynamic fixation longitudinal connecting member according to the invention, shown with three bone screws, with portions broken away to show the detail thereof.

FIG. 10 is an enlarged perspective and exploded view of the connecting member of FIG. 1, shown without the connecting ties.

FIG. 11 is an enlarged and partial perspective view of the connecting member of FIG. 10, with portions broken away to show the detail thereof.

FIG. 12 is an enlarged and partial front elevational view of the connecting member of FIG. 1.

FIG. 13 is an enlarged and partial front elevational view of the connecting member of FIG. 6.

FIG. 14 is an enlarged and partial front elevational view of a cord for use in a sixth embodiment of a dynamic fixation longitudinal connecting member according to the invention.

FIG. 15 is an enlarged and partial front elevational view of the cord of FIG. 14 attached to a plastic member further showing the sixth embodiment according to the invention.

FIG. 16 is an enlarged front elevational view of the sixth embodiment of a connecting member according to the invention, showing the cord and rigid member of FIG. 15 with a sleeve.

FIG. 17 is an enlarged cross-sectional view taken along the line 17-17 of FIG. 16.

FIG. 18 is an enlarged front elevational view of the connecting member of FIG. 16 shown with a pair of bone screws.

FIG. 19 is an enlarged and exploded perspective view of a polyaxial bone screw assembly shown with a dynamic longitudinal connecting member.

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 to FIGS. 1-5 and 10-12, the reference numeral 1 generally designates a non-fusion dynamic stabilization longitudinal connecting member assembly according to the present invention. The connecting member assembly 1 generally includes first and second substantially rigid members 6 and 7 with a central, dynamic connection or transition portion or segment 8 disposed therebetween. A tie or a plurality of ties 10 link the rigid members 6 and 7 at the central segment 8. The ties 10 may be any flexible elongate material that fastens, secures or unites the rigid members 6 and 7, including, but not limited to cords, threads, strings, bands, or fibers that may be single or multiple strands, including twisted, braided or plaited materials. The central segment 8 can further include an inner discrete bumper 11, a wound cover 12 and an outer sleeve or spacer 14.

Each of the illustrated rigid members 6 and 7 are substantially cylindrical with one or more circular cross- sections along a length thereof. However, it is foreseen that the members 6 and 7 may have other forms, including but not limited to oval, square and rectangular cross-sections as well as other curved or polygonal shapes. It is foreseen that the member 6 and 7 may be of different materials, different shapes or different sizes, and thus one member may be more rigid or more flexible than the other member. The members 6 and 7 each are of a length for cooperating with at least one and up to a plurality of bone attachment members, such as bone screws or hooks. In the illustrated embodiment the rigid members 6 and 7 include respective end portions 16 and 17 of a larger diameter being integral or fixed with respective portions 20 and 21 of smaller diameter. A tapered portion 24 is disposed between the portion 16 and the portion 20. A tapered portion 25 is disposed between the portion 17 and the portion 21. In some operational embodiments, the bumper 11 may be disposed between and abut against the portions 20 and 21, as illustrated in FIG. 12. As will be described in greater detail below, the bumper 11 and the portions 20 and 21 are connected by the ties 10; the wound cord cover 12 wraps about the portions 20 and 21 and the bumper 11, forming the central connection or transition portion 8; and the connection portion 8 is received in the outer sleeve or spacer 14. The dynamic connecting member assembly 1 cooperates with at least a pair of bone anchors, such as the polyaxial bone screws, generally 30 and cooperating closure structures 32 shown in FIGS. 4 and 5, the assembly 1 being captured and fixed in place at the larger diameter rigid end portions 16 and 17 by cooperation between the bone screws 30 and the closure structures 32. The sleeve 14 can be cut to size and is shaped to closely fit between pairs of bone screws 30 or other bone anchors or implants, cooperating with the wrapped central connection portion 8 to support adjacent vertebrae.

Because the end portions 16 and 17 are substantially solid and cylindrical, the connecting member assembly 1 may be used with a wide variety of bone anchors already available for cooperation with rigid rods including fixed, monoaxial bone screws, hinged bone screws, polyaxial bone screws, and bone hooks and the like, with or without compression inserts, that may in turn cooperate with a variety of closure structures having threads, flanges, or other structure for fixing the closure structure to the bone anchor, and may include other features, for example, break- off tops and inner set screws. The bone anchors, closure structures and the connecting member assembly 1 are then operably incorporated in an overall spinal implant system for correcting degenerative conditions, deformities, injuries, or defects to the spinal column of a patient.

The illustrated polyaxial bone screw 30 includes a shank 40 for insertion into a vertebra (not shown), the shank 40 being pivotally attached to an open receiver or head 41. The shank 40 includes a threaded outer surface and a central cannula or through-bore 42 disposed along an axis of rotation of the shank, the through-bore 42 extending between a top surface (not shown) and a bottom surface 44 of the shank 40. The bore 42 provides a passage through the shank interior for a length of wire or pin inserted into the vertebra prior to the insertion of the shank 40, the wire or pin providing a guide for insertion of the shank 40 into the vertebra.

The receiver 41 has a pair of spaced and generally parallel arms 45 that form an open generally U-shaped channel 46 therebetween that is open at distal ends of the arms 45. In the illustrated embodiment, each of the arms 45 includes a substantially cylindrical outer surface 47 disposed between a pair of substantially flat, parallel faces 48. The faces 48 are sized and shaped to engage end surfaces of the sleeve or spacer 14 as will be described in greater detail below. Each of the arms 45 also includes a radially inward or interior surface 50 having a discontinuous guide and advancement structure mateable with cooperating structure on the closure structure 32. In the illustrated embodiment, the guide and advancement structure is a partial helically wound flangeform configured to mate under rotation with a similar structure on the closure structure 32. However, it is foreseen that the 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 structures for operably guiding under rotation and advancing the closure structure 32 downward between the receiver arms 45 and having such a nature as to resist splaying of the arms 45 when the closure 32 is advanced into the U-shaped channel 46.

Each of the arms 45 also includes a V-shaped or undercut tool engagement groove 51 formed on an outer surface thereof which may be used for holding the receiver 41 with a holding tool (not shown) having projections that are received within the grooves 51 during implantation of the shank 40 into the vertebra (not shown). The grooves 51 may also cooperate with a holding tool during bone screw assembly and during subsequent installation of the connecting member assembly 1 and the closure structure 32. It is foreseen that tool receiving grooves or apertures may be configured in a variety of shapes and sizes and be disposed at other locations on the receiver arms 45.

The shank 40 and the receiver 41 may be attached in a variety of ways. For example, a spline capture connection as described in U.S. Pat. No. 6,716,214 and incorporated by reference herein, may be used. Polyaxial bone screws with other types of capture connections may also be used according to the invention, including but not limited to, threaded connections, frictional connections utilizing frusto-conical or polyhedral capture structures, integral top or downloadable shanks, and the like. Also, as indicated above, polyaxial and other bone screws for use with connecting members of the invention may have bone screw shanks that attach directly to the connecting member or may include compression members or inserts that cooperate with the bone screw shank, receiver and closure structure to secure the connecting member assembly to the bone screw and/or fix the bone screw shank at a desired angle with respect to the bone screw receiver that holds the longitudinal connecting member assembly. Furthermore, although the closure structure 32 of the present invention is illustrated with the polyaxial bone screw 30 having an open receiver or head 41, it foreseen that a variety of closure structure may be used in conjunction with any type of medical implant having an open or closed head, including monoaxial bone screws, hinged bone screws, hooks and the like used in spinal surgery.

To provide a biologically active interface with the bone, the threaded shank 40 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 (Ca₄P₂0₉), 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.

The longitudinal connecting member assembly members 6 and 7 may be made from metal, metal alloys or other suitable materials, including plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including carbon fiber reinforced PEEK. According to the invention, the members 6 and 7 may be made from the same material or from different materials. For example, the member 6 may be made from a very rigid titanium alloy or a commercially pure titanium, while the member 7 may be made from a more flexible plastic polymer. The bumper 11 and the outer sleeve or spacer 14 may be made of a variety of materials including metals, plastics and composites. The illustrated bumper 11 and sleeve 14 are made from a plastic, such as a thermoplastic elastomer, for example, polycarbonate-urethane. In certain embodiments, in order to reduce the production of micro wear debris, the sleeve 14 inner surfaces 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.

The ties 10 and the cord that is wound about the transition or central connection portion 8 to provide the cord cover 12 may be made from a variety of materials, including polyester or other plastic fibers, strands or threads, such as polyethylene-terephthalate. Such cord and cord-like materials usually are placed under axial tension along the portion 8 during installation to facilitate a stable connecting member assembly, but typically do not illustrate elastic properties, such as any significant additional axial distraction after the assembly 1 is operatively assembled. However, it is foreseen that in some embodiments, the ties 10 and the cord cover 12 may be made of a plastic or rubber (natural or synthetic) having elastic properties, allowing for some further distraction of the central connection portion 8 at the ties 10 during operation thereof. The bumper 11 may be sized and chosen from a range of rigid to elastic materials so as to provide for a relatively more rigid assembly 1 or a relatively more flexible assembly 1 with respect to flex, bendability and/or compressibility along the central connection/transition portion 8.

Returning to the longitudinal connecting member rigid members 6 and 7, the cylindrical portions 20 and 21 of the respective rigid members 6 and 7 each include a respective end surface 53 and 54 and a plurality of through apertures or bores 56, each running perpendicular to a central longitudinal axis of the member 20 or 21 as illustrated in FIG. 11. In the embodiment shown, each portion 20 and 21 has a total of six through bores 56 spaced along a length of the member running between the respective tapered portions 24, 25 and the respective end surfaces 53, 54 and disposed in a spaced helical pattern about the cylindrical portion 20, 21. In the illustrated embodiment six ties or slender cords 10 are sized and shaped for being laced through a bore 56 of each of the portions 20 and 21 and over the bumper 11 in a pattern as best shown in FIG. 12, thus making six discrete looped connections 10a, 10b, 10c, 10d, 10e and 10f between the portion 20 and the portion 21 and capturing the bumper 11 therebetween. See, for example, the loop 10a that is shown on either side of the portions 20 and 21 in FIG. 12 and further shown in phantom extending through the bores 56, illustrating the discrete nature of each loop. It is also foreseen that in alternative embodiments, greater or fewer than six ties or even a single tie 10 may be laced through numerous apertures in the portions 20 and 21 to connect the portion 20 with the portion 21. In the illustrated embodiment, ends of each of the elongate ties 10 are knotted, fused or otherwise secured to provide each discrete loop 10a, 10b, 10c, 10d, 10e and 10f.

As illustrated in FIG. 10, the bumper 11 is substantially cylindrical and includes outer grooves 60 sized and shaped to receive the ties 10 and thereby provide a channel for each tie 10 to aid in a uniform alignment of the tie 10 between the portions 20 and 21. The bumper 11 further includes substantially planar opposed front and back surfaces 62 and 63 for contact with respective surfaces 53 and 54 of the portions 20 and 21.

As illustrated in FIG. 2, the cord cover 12 is also a strand or cord that is wrapped about the portions 20 and 21 and the bumper 11 and then secured thereto by tying, fusing or otherwise fixing. The cord cover 12 may be made out of a variety of materials, including polyester fiber. When the mid portion 8 formed by the portions 20 and 21, bumper 11, the ties 10 and the cord cover 12 is fixed to bone screws 30 by engagement of the end portions 16 and 17 with such screws, the tie-connected mid-portion 8 in combination with the sleeve 14 provides relief (e.g., shock absorption) and limited movement with respect to flexion, extension, torsion, distraction and compressive forces placed on the assembly 1.

With particular reference to FIG. 3, the sleeve or spacer 14 advantageously cooperates with the corded 12 central connection or transition portion 8, providing limitation and protection of movement of the portion 8. The sleeve 14 also protects patient body tissue from damage that might otherwise occur in the vicinity of the corded central portion 8. Thus, the sleeve 14 is sized and shaped for substantially even and precise alignment and substantial contact between flat end faces 68 and 69 of the sleeve 14 and cooperating flat side surfaces 48 of the receivers 41. Furthermore, as will be discussed in greater detail below, in certain embodiments according to the invention, when the sleeve 14 is implanted, and the closure structures 32 are tightened, the tools utilized to implant the assembly 1 and/or the bone screws 30 may be manipulated so as to axially compress the sleeve 14, now substantially coaxial with the central connection portion 8 axis A, between facing surfaces 48 of adjacent receivers 41. In some embodiments, such compression during installation results in some additional tension and/or distraction of the ties 10 of the central connection portion 8 when the implantation tools are removed from the bone screws 30, as the sleeve surfaces 68 and 69 then press against the facing bone screw surfaces 48, but the connection portion 8 is otherwise fixed with respect to each of the bone screws 30 as the portions 16 and 17 are each fixedly captured within a receiver channel 46. Such dynamic tension/compression relationship between the sleeve 14 and the central connection portion 8 provides further strength and stability to the overall assembly.

The illustrated sleeve 14 is substantially cylindrical with an external substantially cylindrical surface 70 and an internal substantially cylindrical and smooth surface 72 defining a bore with a circular cross section extending through the sleeve 14. It is foreseen that in some embodiments, the sleeve may be of square, rectangular or other cross-section including curved or polygonal shapes. In the illustrated embodiment, the sleeve 14 further includes a plurality of compression grooves 78. Sleeves according to the invention may include one, none or any desired number of grooves 78. Each of the illustrated grooves 78 is substantially uniform and circular in cross- section, being formed in the external surface 70 and extending radially toward the internal surface 72. The internal surface 72 is of a slightly greater diameter than a substantially cylindrical outer diameter formed by the cover 12 that wraps about the central connection portion 8. The cord cover 12 outer surface is substantially flush with the larger diameter portions 16 and 17, resulting in a connecting member with an overall substantially uniform outer diameter. The size of the internal surface 72 allows for axially directed sliding movement of the sleeve 14 with respect to the end portions 16 and 17 and the central portion 8. When the sleeve 14 is received about the central connection portion 8, the sleeve 14 completely surrounds the central portion 8 as illustrated in FIG. 3. It is noted that in addition to limiting the bendability of the central connection portion 8 and thus providing strength and stability to the assembly 1, the sleeve 14 also keeps scar tissue from growing into the portion 8 through the wound cord cover 12, thus eliminating the need for a sheath-like structure to be placed, adhered or otherwise applied to the cord cover 12 on the central connection portion 8.

With reference to FIG. 4, the closure structure 32 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 the interior surface 50 of the upstanding arms 45 of the receiver 41. The illustrated closure structure 32 is rotatable between the spaced arms 45, but could be a slide-in closure structure. The illustrated closure structure 32 is substantially cylindrical and includes an outer helically wound guide and advancement structure in the form of a flange form that operably joins with the guide and advancement structure disposed on the interior 50 of the arms 45. 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 the closure structure 32 downward between the arms 45 and having such a nature as to resist splaying of the arms 45 when the closure structure 32 is advanced into the U-shaped channel 46. The illustrated closure structure 32 also includes a top surface with an internal drive in the form of an aperture 80 that may be a hex drive, a star-shaped internal drive, for example, sold under the trademark TORX or other internal drives such as 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 the internal drive 80 is used for both rotatable engagement and, if needed, disengagement of the closure 32 from the arms 45. It is also foreseen that the closure structure 32 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.

In use, at least two bone screws 30 are implanted into vertebrae for use with the longitudinal connecting member assembly 1. Each vertebra may be pre-drilled to minimize stressing the bone. Furthermore, when a cannulated bone screw shank is utilized, each vertebra will have a guide wire or pin (not shown) inserted therein that is shaped for the bone screw cannula 42 of the bone screw shank 40 and provides a guide for the placement and angle of the shank 40 with respect to the cooperating vertebra. A further tap hole may be made and the shank 40 is then driven into the vertebra by rotation of a driving tool (not shown) that engages a driving feature on or near a top portion of the shank 40. It is foreseen that the screws 30 and the longitudinal connecting member assembly 1 can be inserted in a percutaneous or minimally invasive surgical manner.

With particular reference to FIGS. 2-3, the longitudinal connecting member assembly 1 that has been factory assembled to include the bumper 11, looped ties 10 and the cord cover 12 is assembled with the sleeve 14 by inserting either the end portion 16 or end portion 17 into the bore defined by the inner cylindrical surface 72 of the outer sleeve 14. The sleeve 14 is moved into position over the central portion 8 and between the end portions 16 and 17, thus covering or encompassing the cord cover 12.

The connecting member assembly 1 is eventually positioned in an open or percutaneous manner in cooperation with the at least two bone screws 30 with the sleeve 14 disposed between the two bone screws 30 and the end portions 16 and 17 each within the U-shaped channels 46 of the two bone screws 30. A closure structure 32 is then inserted into and advanced between the arms 45 of each of the bone screws 30. The closure structure 32 is rotated, using a tool engaged with the inner drive 80 until a selected pressure is reached at which point the end portion 16 or 17 is urged toward, but not completely seated in the channel 46. For example, about 80 to about 120 inch pounds pressure may be required for fixing the bone screw shank 40 with respect to the receiver 41. Downward movement of the closure structure 32 into the channel 46 presses a respective end portion 16 or 17 downward into engagement with a top or other upper portion of the respective bone screw shank 40, pressing a respective retaining structure (not shown)or shank head portion into engagement with the respective receiver 41, thus setting an angle of articulation of the respective shank 40 with respect to the respective receiver 41, clamping the shank 40 into a fixed position with respect to the receiver 41. The receiver 41, the shank 40 and the retaining structure cooperate in such a manner that the receiver 41 and the shank 40 can be secured at any of a plurality of angles, articulations or rotational alignments relative to one another and within a selected range of angles both from side to side and from front to rear, to enable flexible or articulated engagement of the receiver 41 with the shank 40 until both are locked or fixed relative to each other.

Alternatively, it is foreseen that the capture of the connecting member assembly 1 by bone screws or other bone anchors and cooperating closure structures could further involve the use of an upper and/or a lower compression member or insert disposed within the receiver 41. Furthermore, the assembly 1 may cooperate with an open receiver that is integral or fixed in position with respect to a bone screw shank or bone hook, or with a receiver having limited angular movement with respect to the shank, such as a hinged connection, also with or without other compression members or inserts for fixing the assembly 1, the receiver and/or the bone anchor in a desired position or orientation with respect to the cooperating vertebrae.

Prior to final tightening of the closure structures 32 the members 6 and 7 may be pulled away from one another to place the central connection portion 8 in tension. Also, in certain embodiments, as the closure structures 32 are rotated and then tightened against the end portions 16 and 17 within a pair of spaced bone screws 30, the bone screws 30 may be tilted or otherwise pressed toward one another, thereby compressing the sleeve 14. When the insertion and tightening tools are removed, the sleeve 14, pressing against facing surfaces 48 of the cooperating bone screw receivers 41, placing additional axial tension upon ties 10 and the cord cover 12 of the central connection portion 8. The assembly 1 is thus substantially dynamically loaded and oriented relative to the cooperating vertebra, providing stress relief (e.g., some shock absorption) and protected movement with respect to flexing and compressive forces (and in certain embodiments, if elastic ties and cord cover are utilized, also distractive forces) placed on the assembly 1 and the two connected bone screws 30. The ties 10 and the bumper 11 also allow the central portion 8 to twist or turn, providing relief for torsional stresses. The sleeve 14 limits such torsional movement as well as bending movement of the central connection portion 8, providing spinal support.

If removal of the assembly 1 from any of the bone screw assemblies 30 is necessary, or if it is desired to release the assembly 1 at a particular location, disassembly is accomplished by using the driving tool (not shown) that mates with the internal drive 80 on the closure structure 32 to rotate and remove the closure structure 32 from the receiver 41. Disassembly is then accomplished in reverse order to the procedure described previously herein for assembly.

Eventually, if the spine requires more rigid support, the connecting member assembly 1 according to the invention may be removed and replaced with another longitudinal connecting member, such as a solid rod, having the same diameter as the end portions 16 and 17, utilizing the same receivers 41 and closure structures 32. Furthermore, it is noted that the end portion 16 and/or 17 may be elongate, allowing for connection of a rigid rod portion or portions of the assembly 1 with additional bone screws or other bone anchors along a patient's spine.

With particular reference to FIGS. 6 and 13, an alternative longitudinal connecting member assembly embodiment according to the invention, generally 101 includes a flexible cord or cable 105 attached to a rigid member 107 that is identical or substantially similar to the member 7 previously described herein. The cord 105 is both flexible and strong and may be made from a variety of materials including but not limited to polyester fibers that are twisted, plaited, bonded or otherwise connected to result in a strong cord or rope. The cord 105 is sized and shaped to be received in a bone screw or other bone anchor 130. The cord 105 may be of a polyethylene material as is known in the art for use with cannulated spacers and cooperating bone anchors. Such a cord typically extends or stretches somewhat but exhibits little further elasticity after being tensioned during implantation.

The member 107 includes a larger diameter portion 117 receivable in the bone anchor 30 previously described herein, a smaller diameter portion 121, a tapered portion 125, an end surface 154 and through bores 156 spaced in a helical pattern, all of which are identical or substantially similar to the larger diameter portion 17, smaller diameter portion 21, tapered portion 25, end surface 54 and spaced through bores 56 of the rigid member 7 previously described herein with respect to the assembly 1. Similar to the assembly 1, the assembly 101 has a central connection portion 108 that includes the smaller diameter portion 121 and further includes a bumper 111, ties 110, a cord cover 112 and an outer sleeve 114 identical or substantially similar to the respective bumper 11, ties 10, cord cover 12 and sleeve 14 of the assembly 1 previously described herein. The individual ties 110 are threaded through, integral or integrally woven into the larger cord or cable 105 and then form discrete loops 110a, 110b, 110c, 110d, 110e and 110f that pass through the bores 156 in the portion 121 of the member 107 in a manner substantially similar to the cord loops 10a, 10b, 10c, 10d, 10e and 10f extending through the portion 21 of the member 7 of the assembly 1.

The assembly 101 is shown attached to a bone screw 30 previously described herein at the end portion 117 and to the fixed, closed bone screw 130 at the flexible cord portion 105. For example, suitable hinged and fixed bone screws for mating with the cord 105 are described in Applicant's U.S. patent application Ser. No. 11/328,481 filed Jan. 9, 2006, Publication No. 20060111715, incorporated by reference herein. Although not shown, both the illustrated polyaxial and fixed bone screws each include a closure structure with a helically wound guide and advancement structure for mating engagement with the particular bone screw. Since the bone screw 130 is of a closed, fixed construction the mating closure structure (not shown) is a set screw. Furthermore, in order to securely fix the cord 105 in place, the set screw may include points or other protruding structures and/or a compression or holding member or insert may desirably be placed between the cord 105 and the set screw or other closure structure.

As with the assembly 1, the assembly 101 readily cooperates with a wide variety of bone anchors and closures, also as previously described herein at the rigid portion 107 and further cooperates with a variety of bone anchors adapted for use with cords at the portion 105, and thus is not limited in use to the particular bone screws disclosed herein.

In use, the longitudinal connecting member assembly 101 is factory assembled to provide the flexible central transition portion 108 that includes the bumper 111 captured between the section 121 and the cord 105 by the looped ties 110 as illustrated in FIG. 13 and further protected by the cord cover 112 as shown in FIG. 6. The sleeve 114 is slidable onto both the rigid portion 107 and the corded portion 105, and placable about the cord covered central or transition portion 108, also as shown in FIG. 6. The sleeve 114 (as well as the sleeve 14 previously described herein) may be cut to the precise desired size by the surgeon. The connecting member assembly 101 is eventually positioned in an open or percutaneous manner in cooperation with the bone screws 30 and 130 with the sleeve 114 disposed between the two bone screws 30 and fitting closely therebetween. The corded portion 105 is tensioned during installation. As with the assembly 1, in certain embodiments according to the invention, when the closure structures are inserted into the bone screws, the sleeve 114 may be compressed by moving the bone screws 30 and 130 toward one another during tightening of the closure structures within the bone screw receivers. When the insertion and tightening tools are removed, the sleeve 114, pressing against facing surfaces of the adjacent cooperating bone screw receivers places additional tension on the ties 110 of the central connection portion 108. The assembly 101 is thus substantially dynamically loaded and oriented relative to the cooperating vertebra. The ties 110 and the bumper 111 also allow the central portion 108 to compress and twist or turn, providing relief for torsional stresses. The sleeve 114 limits such torsional movement as well as bending movement of the central connection/ transition portion 108, providing spinal support. Furthermore, if the sleeve 114 is compressed during installation, the sleeve may extend slightly in response to body motion and/or flexion of the transition portion 108, for example.

With reference to FIGS. 7, 8 and 9, dynamic longitudinal connecting members according to the invention may include rigid rod portions, flexible cords and flexible cord/rod transition portions in a variety of combinations as desired to provide both rigid and/or various levels of dynamic support of a patient's spine. For example, a third embodiment according to the invention shown in FIG. 7 and generally designated 201 includes a transition portion or segment 108A substantially identical to the portion 108 previously described herein and shown in FIG. 6. However a rigid rod portion 107A is of a longer length than the rigid portion 107 shown in FIG. 6, the rigid portion 107A sized to be received in two bone screws 30.

With reference to FIG. 8, a fourth embodiment according to the invention, generally 301 includes a central connection or transition portion 108B identical or substantially similar to the portion 108 previously described herein and shown in FIGS. 6 and 13. However, the longitudinal connecting member 301 includes an extended cord portion 105B and an extended rigid portion 107B. The connecting member 301 is thus sized and shaped to attach to at least four bone screws: illustrated herein as two polyaxial screws 30 at the portion 107B, a fixed or monoaxial closed bone screw 130 and a fixed open bone screw 130′ at the cord 105B. Thus, the member 301 provides an extended length of flexible dynamic stabilization at the transition 108B and the cord 105B as well as extended rigid support along the rigid length 107B. Two sleeves 114B that are identical or substantially similar to the sleeve 14 previously described herein are included in the embodiment 301: one between the screw 130 and the screw 130′ and the other between the screw 130′ and the polyaxial screw 30. It is further noted that the rigid portion 107B may be straight or curved, pre-bent or curvilinear.

With reference to FIG. 9, another alternative longitudinal connecting member assembly according to the invention, generally 401 includes a connection or transition portion BC identical or substantially similar to the portion 8 previously described herein and shown in FIGS. 1-5 and 12 and also a connection or transition portion 108C identical or substantially similar to the portion 108 previously described herein and shown in FIG. 6. Thus, the connecting member 401 includes a cord 105C similar to the cord 105 of the connecting member 1 and also end portions 106C and 107C similar to respective portions 6 and 7 of the connecting member 1. The connecting member 401 is thus sized and shaped to attach to at least three bone screws: two polyaxial screws 30 at the portions 106C and 107C; and a fixed or monoaxial closed bone screw 130 at the cord 105C. Thus there is provided a flexible dynamic stabilization along the entire connecting member 401, with both of the transition portions BC and 108C being surrounded and protected by sleeves 114C that are identical or substantially similar to the sleeve 14 previously described herein with respect to the connecting member 1.

With reference to FIGS. 14-18 another alternative longitudinal connecting member assembly according to the invention, generally 501 includes a flexible cord or cable 505 attached to a molded plastic member 507 that may be rigid or have some flexibility, depending upon the material used to fabricate the member 507. The cord 505 is identical or substantially similar to the cord 105 previously described herein with respect to the connecting member assembly 101 and is shown in FIG. 18 received within the closed fixed bone screw 130 previously described herein. Near an end 508 thereof, the cord 505 includes smaller diameter elongate ties, strands or fibers 510 that are integral, integrally woven, or otherwise fixed to the cord 505. The cord 505 and the plastic member 507 may be fixedly attached to one another in a variety of ways. In one embodiment according to the invention, small apertures or holes are drilled in the plastic member 507 at or near the end 520. Such apertures may be drilled parallel to a longitudinal axis L of the plastic member 507 or at an angle thereto, such as an angle oblique to the longitudinal axis L. The strands 510 are then inserted or plugged into the apertures in the plastic member 507 and adhered to the plastic member 507 with an adhesive and/or heat. The adhesive may be applied before, during or after plugging of the apertures with the strands 510, with both the adhesive and the strands 510 extending into and penetrating the member 507 at the drilled apertures.

Also with reference to FIGS. 14-18, alternatively, the strands 510 are embedded into the member 507 during a fabrication process wherein the member 507 is molded adjacent to the cord 505 with the strands 510 being molded within the molded plastic of the member 507. Thus, during fabrication, the plastic flows in and around and bonds to the individual strands or fibers 510, resulting in a single or discrete longitudinal connecting member 501 both a corded portion and a solid cylindrical portion. It is believed that certain process parameters, such as performing the molding process in a vacuum, further aids in the adhesion or bonding of the plastic material to the strands or fibers 510. Longitudinal connecting members according to the invention may include one or more corded or molded sections along a length thereof. Molded sections made from different materials may be included along a length of a connecting member with corded sections disposed therebetween.

With particular reference to FIGS. 15 and 17, the illustrated molded member 507 is in the form of a cylindrical rod that includes the end 520 that is disposed near or approximately at the end 508 of the cord such that all of the strands or fibers 510 are substantially imbedded or adhered within the molded member 507. The molded member 507 may be made from a variety of rigid or flexible plastics, including but not limited to plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites. It is foreseen that in certain embodiments according to the invention, the molded member may include elastomeric materials, such as natural or synthetic elastomers, including, but not limited to polyisoprene (natural rubber), and synthetic polymers, copolymers, and thermoplastic elastomers, and mixtures thereof. Although illustrated as a solid rod with a circular cross-section, the member 507 may have other forms, including but not limited to oval, square and rectangular cross-sections as well as other curved or polygonal shapes of various sizes.

The assembly 501 further includes a sleeve or spacer 514 having an outer cylindrical surface 570 and a plurality of grooves 578. The sleeve 501 is identical or substantially similar to the sleeves 14 and 114 previously described herein with respect to the respective assemblies 1 and 101. The sleeve 514 receives either the cord 505 or the molded member 507 and is eventually operatively positioned over the end 520 that is the juncture between the cord 505 of the molded member 507. In order to have low or no wear debris, the sleeve 514 inner surfaces and/or outer surfaces of a cooperating portion of the member 507 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 foreseen that the member 507 may be sized and made from such materials as to provide for a relatively more rigid assembly 501 or a relatively more flexible assembly 501 with respect to flex or bendability along the portion 507. When the portion 505 is elongate, sleeves 514 are disposed between bone screws along such length. Furthermore, if the member 507 is flexible, sleeves 514 are preferably disposed between bone screws along the member 507 length. Also, since the distance between the bone screws can vary, the member 507 may need to be more or less stiff.

The assembly 501 is shown attached to a bone screw 30 previously described herein at the member 507 and to the fixed, closed bone screw 130 previously described herein at the flexible cord portion 505. As with the cord portion 105 previously described herein, suitable hinged and fixed bone screws for mating with the cord 505 are described in Applicant's U.S. patent application Ser. No. 11/328,481 filed Jan. 9, 2006, Publication No. 20060111715, incorporated by reference herein. Although not shown, both the illustrated polyaxial and fixed bone screws each include a closure structure with a helically wound guide and advancement structure for mating engagement with the particular bone screw. Since the bone screw 130 is of a closed, fixed construction the mating closure structure (not shown) is a set screw. Furthermore, in order to securely fix the cord 505 in place, the set screw may include points or other protruding structures and/or a compression or holding member or insert may desirably be placed between the cord 505 and the set screw or other closure structure.

As with the assemblies 1 and 101 previously described herein, the assembly 501 readily cooperates with a wide variety of bone anchors and closures, also as previously described herein at the solid molded portion or member 507 and further cooperates with a variety of bone anchors adapted for use with cords at the member 505, and thus is not limited in use to the particular bone screws disclosed herein.

In use, the longitudinal connecting member assembly 501 is factory fabricated by a molding and/or machining and bonding process to provide a singular longitudinal connecting member having the corded member or portion 505 and a solid molded member or portion 507. The sleeve 514 is cut to the precise desired size by the surgeon for fitting closely between the bone screws 30 and 130. The sleeve 514 is then slid onto either the molded member 507 or the corded portion 505, and placed about the connecting member 501 at the transition portion indicated by the end 520 of the molded member 507 as shown in FIG. 16. The connecting member assembly 501 is eventually positioned in an open or percutaneous manner in cooperation with the bone screws 30 and 130 with the sleeve 514 disposed between the two bone screws 30 and fitting closely therebetween. The corded portion 505 disposed between the bone screw 130 and the molded member 507 is typically tensioned during installation. As with the assembly 1, in certain embodiments according to the invention, when the closure structures are inserted into the bone screws, the sleeve 514 may be compressed by moving the bone screws 30 and 130 toward one another during tightening of the closure structures within the bone screw receivers. In such embodiments, for example, when the molded member 507 has some elastomeric properties, when the insertion and tightening tools are removed, the sleeve 514, pressing against facing surfaces of the adjacent cooperating bone screw receivers places additional tension upon the cord 505 and molded member 507 that make up a transition portion that is disposed between the two bone screws 30 and 130. The assembly 501 is thus substantially dynamically loaded and oriented relative to the cooperating vertebra. The sleeve 514 limits torsional movement as well as bending movement of the cord/rod transition portion that is disposed between the bone screws 30 and 130, providing spinal support. Furthermore, if the sleeve 514 is compressed during installation, the sleeve may extend during body motion (with possible simultaneous distraction of the transition portion if the member 507 includes an elastomeric material).

If removal of the assembly 501 from any of the bone screw assemblies 30 or 130 is necessary, or if it is desired to release the assembly 501 at a particular location, disassembly is accomplished by using the driving tool (not shown) that mates with the internal drives of the cooperating closure structures or set screws to rotate and remove such closure structure or set screw from the bone screws 30 or 130. Disassembly is then accomplished in reverse order to the procedure described previously herein for assembly.

With reference to FIG. 19, an alternative polyaxial bone screw, generally 601 of the invention and an alternative longitudinal connecting member, generally 605, for use in the invention, are illustrated. The polyaxial bone screw 601 includes a shank 608, a receiver 610 and a retaining and articulating structure 612. The shank 608 further includes a threaded shank body 616 and an integral shank upper portion 618. The illustrated receiver 610 includes tool attachment structure generally, 620 for cooperating and engaging with an insertion tool. The illustrated receiver 610 is further sized and shaped to cooperate and engage with a closure structure previously described herein or other suitable bone screw closure structure.

The illustrated longitudinal connecting member 605 cooperates with two or more bone screws 601 and is a non-fusion dynamic stabilization longitudinal connecting member assembly having an outer, cannulated coil-like connecting member 630 and one or more threaded inserts 632. Also, a solid cylindrical core or insert (not shown) may replace the insert 632 and be attached to the core at only one end thereof and be slidingly receivable within the core along a substantial or entire length of the coil-like member 630. Furthermore, longitudinal connecting members made from solid rods or rods having solid or substantially hollow portions of non-uniform cross-section may be used with bone screw assemblies and tools according to the invention.

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

1. 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 substantially solid connecting member portion attached to the first bone anchor; and

b) a transition portion disposed between the first and second bone anchors, the transition portion having at least one flexible tie attached to both the first connecting member portion and to a second discrete connecting member portion, the second connecting member portion being attached to the second bone anchor.