SOFT STABILIZATION ASSEMBLIES WITH OFF-SET CONNECTOR
A spinal longitudinal connecting member includes a soft stabilization assembly segment having a tensioned cord and a hard rod segment. A connector in fixed engagement with the hard rod also captures the tensioned cord of the soft segment, the connector being in fixed or sliding relation with the tensioned cord. The connector places the soft assembly segment in lateral or off-set and staggered relation to the hard rod segment. The connector may be integral to a bone anchor.
This continuation application claims priority under 35 U.S.C. §120 from co-pending U.S. Nonprovisional Application No. 14/171,168 entitled “SOFT STABILIZATION ASSEMBLIES WITH OFF-SET CONNECTOR,” filed on Feb. 3, 2014, which claims priority under 35 U.S.C. §119 from U.S. Provisional Application No. 61/849,934 entitled “SOFT STABILIZATION ASSEMBLIES WITH OFF-SET CONNECTOR,” filed Feb. 5, 2013.
U.S. Nonprovisional Application No. 14/171,168 is also a continuation-in-part of and claims priority from U.S. Nonprovisional Application No. 12/802,849 entitled “LONGITUDINAL CONNECTING MEMBER WITH SLEEVED TENSIONED CORDS,” filed Jun. 15, 2010 which claims priority from U.S. Provisional Application No. 61/268,708 entitled “DYNAMIC STABILIZATION ASSEMBLY WITH CORD AND FLUSH SLIDING SLEEVES,” filed Jun. 15, 2009; U.S. Provisional Application No. 61/270,754 entitled “DYNAMIC STABILIZATION ASSEMBLY WITH CORD AND FLANGED SLEEVES,” filed Jul. 13, 2009; U.S. Provisional Application No. 61/336,911 entitled “POLYAXIAL BONE ANCHOR WITH NON-PIVOTABLE SNAP-ON SPRING RING AND FRICTION FIT INSERT,” filed Jan. 28, 2010; U.S. Provisional Application No. 61/395,564 entitled “POLYAXIAL BONE ANCHOR WITH FRICTION FIT CROWN INSERT, POP-ON SHANK AND FLANGE FORM CLOSURE,” filed May 14, 2010; U.S. Provisional Application No. 61/395,752 entitled “POLYAXIAL BONE ANCHOR WITH POP-ON DIRECT ENGAGEMENT SHANK,” filed May 17, 2010; and U.S. Provisional Application No. 61/396,390 entitled “POLYAXIAL BONE ANCHOR WITH POP-ON DIRECT ENGAGEMENT SHANK,” filed May 26, 2010, all of which are incorporated by reference herein for all purposes.
BACKGROUND OF THE INVENTIONThe present invention is directed to soft or 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.
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, distraction, compression, side bending 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. Such cord or strand-type systems have typically required specialized bone anchors and tooling for tensioning and holding the cord or strand in the bone anchors.
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 INVENTIONLongitudinal connecting member assemblies according to the invention for use between at least two bone anchors provide soft or dynamic, protected motion of the spine and may be extended to provide additional soft or dynamic sections or more rigid support along an adjacent length of the spine, with fusion, if desired. An illustrated longitudinal connecting member assembly according to an embodiment of the invention includes a soft portion or segment connected to a more rigid or hard portion or segment by a transversely oriented connector structure, the connector structure placing the soft portion of the assembly in parallel but lateral or off-set and staggered relationship with the hard portion of the assembly. Stated in another way, when implanted onto a patient's spine, the assembly generally runs along a portion of the spine with a connector attaching a soft elongate segment with a hard elongate segment; however, the soft and hard elongate segments of the assembly are not directly in line with one another but rather are positioned medial/lateral or lateral/medial with respect to one another. The soft portion of the assembly includes an inner segment or core, typically a tensioned cord or cords, the core being fixed at either end thereof to substantially rigid segments or structures, the rigid segments including but not limited to the off-set connector structure, bone anchors (typically bone screws, such as mono-axial or poly-axial screws), or end blocking structures or stops that are not part of a bone anchor or screw structure. The core is also usually surrounded by a spacer that may be elastomeric or hard and rigid. Furthermore elastomeric bumpers may be used at locations along the soft portion of the assembly and about the tensioned cord or core to provide a continuous axial load. The tensioned inner core or cord of the soft portion of the assembly and one or more compressed spacers and/or bumpers cooperate dynamically, such features also having some flexibility in bending, but also protecting and limiting flexing movement of the inner core. The rigid or hard portion of the assembly is typically a hard rod or bar that is attached to both the off-set connector structure and to one or more bone anchors. The off-set connector may be closed or open at a top thereof, having structure for mating cooperation with set screws or other closure tops that in turn have structure for fixing to the soft portion inner core or to the hard rod portion located within the off-set connector structure. In some embodiments, the off-set connector is integral with a bone anchor. Assemblies of embodiments of the invention may include mono-and/or poly-axial bone anchors, both open and closed. Typically open mono- or poly-axial bone anchors are fixed to the hard rod portion of the assembly, while either open or closed bone anchors may be used to capture, and if desired, fix the inner core of the assembly soft portion against the respective bone anchor. In certain embodiments it may be desirable to allow the soft core or cord to be in sliding engagement with the off-set connector and also with one or more bone anchors.
A variety of embodiments according to the invention are possible. 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 and up to a plurality of bone anchors.
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.
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
The illustrated soft segment 3 of the assembly 1 includes the following components: an elongate bendable and soft, flexible core in the form of a tensioned cord 4; a cannulated spacer 6 that may be compressible; two elastic bumpers 8; and a fixing structure or blocking member in the form of a blocker 10 with cooperating set screw 11 sized and shaped for pressing against and/or into the cord 4 and fixing the cord with respect to the blocker 10. The hard portion or segment 3′ is illustrated as a cylindrical rod 14.
The assembly 1 is shown with two closed monoaxial bone screws 16 and three open monoaxial bone screws 18. The closed screws 16 each have an upper portion or head 21 integral with a lower shank 22 having at least one helical thread form for rotating and driving the screw into a vertebra. Each head 21 has a cylindrical opening 24 formed in a top thereof that is sized, shaped and threaded for mating with a set screw, such as the set screw 11′, best illustrated in
The tensioned cord 4, spacer 6, bumpers 8 and blocker 10 with set screw 11 are identical or substantially similar to the longitudinal connecting member components identified by the same names and described in greater detail in Applicant's '657 application, the disclosure of which has already been incorporated by reference herein. For example, a tensioned cord 1004 is shown in FIGS. 28-32 of the '657 application and described in paragraph 146 therein that is the same or substantially similar in form and function to the tensioned cord 4. Spacers 1006 and 2006, for example, are shown in FIGS. 30-32 and 44-49, respectively, of the '657 application and described in paragraphs 147 and 168-72 therein that are the same or substantially similar in form and function to the spacer 6. Bumpers 1008 and 2008, for example, are shown in FIGS. 30-32 and 44-49, respectively, of the '657 application and described in paragraphs 148-49 and 168-72 therein that are the same or substantially similar in form and function to the elastic bumpers 8. A blocker and set screw combination 2010, 2011 is shown in FIGS. 44-49 of the '657 application and described in paragraph 170 therein that is the same or substantially similar in form and function to the end blocker 10 and set screw 11 combination. Spacers 6 and bumpers 8 of embodiments of the invention are typically cylindrical tubes prior to assembly, but may be formed in other geometric shapes. Also, it is noted that the illustrated elastic bumpers 8 shown in the drawings are shown compressed in the drawing figures and thus are not shown as cylinders, but rather in a compressed form wherein the bumper bulges outwardly at a middle portion thereof.
With particular reference to
In the illustrated embodiment, the through bores defined by the cylindrical surfaces 50 and 52 are substantially the same size, allowing a user to laterally connect any two longitudinal connecting member assembly segments, either soft or hard without concern of how to orient the connector 2 with respect to such segments. Thus, the connector 2 may be used with or without a hard rod. For example, two soft connector segments, possibly having spacers or bumpers of different durometer or segments that differ only in length may be medially/laterally connected in a staggered manner by the connector 2. Similarly, both the threaded bores 70 and 72 are shown having the same diameter and thus only the closures or screws would need to be different in height to adequately fix against a hard rod 14 or a soft tensioned cord 4. As shown in
It is foreseen that in other embodiments of the invention, the cylindrical surface 50 that slidingly receives the cord 4 may have a diameter that is smaller than a diameter of the surface 52 that slidingly receives the rod 14. Also, the set screw receiving surfaces 70 and 72 may have different diameters, thus requiring various set screws of not only different heights but also different diameters for cooperating with either side of the connector 2.
With further reference to
With reference to
With reference to
With respect to
With reference to
It is foreseen that a connector may also include two open channels, one for receiving a rod and the other for receiving a cord 4. Furthermore, such a dual open channel embodiment could be integral with a bone screw shank.
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. A longitudinal connecting member assembly having first and second bone anchors spanning between first and second vertebrae, the assembly comprising:
- a) a soft portion having a cord in continuous tension, the cord being in slideable relation with the first bone anchor, wherein the anchor is positioned between an end blocker-bumper and a spacer;
- b) a hard portion being in fixed relation with the second bone anchor;
- c) a connecting structure in fixed relation with the hard portion and in one of a fixed and a sliding relation with the cord, the connecting structure positioning the soft portion in a lateral and staggered relation with the hard portion;
- d) a hard end structure fixed to the cord; and
- e) an elastic bumper and a spacer both being in slidable relation with the cord, the elastic bumper positioned between the end structure and the first bone anchor, the first bone anchor being positioned between the elastic bumper and the spacer.
2. The assembly of claim 1 further comprising a third bone anchor attached to a third vertebra, the third bone anchor fixed to the hard structure.
3. The assembly of claim 1 further comprising a third bone anchor attached to a third vertebra, the third bone anchor fixed to the cord, the cord in slidable relation with the connecting structure.
4. The assembly of claim 1 wherein the elastic bumper is a first bumper and further comprising a second elastic bumper, the first and second bumpers located on either side of the connecting structure.
5. The assembly of claim 4 further comprising a third bone anchor fixed to the cord, the first bumper located adjacent the first bone anchor and the second bumper located adjacent the third bone anchor.
6. The assembly of claim 1 wherein the connecting structure has a first through bore for receiving the cord and a second through bore for receiving the hard portion, the first and second through bores being parallel.
7. The assembly of claim 6 wherein the connecting structure has and a third bore disposed perpendicular to the first through bore and in communication therewith and a fourth bore disposed perpendicular to the second through bore and in communication therewith, the third bore having a thread for mating engagement with a set screw, the set screw sized and shaped for frictionally fixing the cord against the connecting structure.
8. The assembly of claim 7 wherein the fourth through bore has a helical guide and advancement structure formed thereon, the guide and advancement structure sized and shaped for mating engagement with a closure top, the closure top fixing the hard portion within the connecting structure.
9. The assembly of claim 1 wherein the hard portion is a cylindrical rod.
10. The assembly of claim 1 wherein the connecting structure is integral with a third bone anchor.
11. The assembly of claim 1 wherein the hard portion is a cylindrical rod and the connecting structure has an open channel sized and shaped for receiving the hard rod.
12. In a spinal longitudinal connecting member assembly having a soft segment and a hard rod segment, the soft segment having a tensioned inner core, the tensioned inner core being captured within a first bone anchor and the rod segment being attached to second and third bone anchors, the improvement comprising:
- a) a connector structure oriented transverse to both the soft segment and the hard rod segment, the connector structure fixed to the hard rod and capturing the tensioned inner core, the connector structure being in one of sliding and fixed relation to the tensioned inner core, the inner core being in sliding relation with respect to the first bone anchor; and
- b) a rigid end blocker fixed to the tensioned inner core and spaced from the connector structure.
13. A spinal connector structure for attaching a rod segment to a soft stabilization longitudinal connecting assembly segment, the assembly having a tensioned cord, a spacer surrounding the cord and a rigid end structure fixed to the cord, the connector structure comprising:
- a) a body forming first and second parallel through bores, the first bore sized and shaped for receiving and capturing the tensioned cord in a sliding relation thereto and the second bore sized and shaped for receiving and capturing the rod, the first and second bores placing the soft stabilization segment and the rod segment in staggered lateral/medial parallel orientation to one another, the body also having an open channel communicating with and disposed perpendicular to the second through bore, the channel sized and shaped for receiving the rod, the channel being partially defined by a first helically wound flange form; and
- b) a closure structure extending into the aperture having a second helically wound flange form sized and shaped for mating engagement with the first flange form, the closure structure being sized and shaped for frictional engagement with the rod located in the second bore.
14. The spinal connector structure of claim 13 wherein the connector structure is a bone anchor having a shank.
15. A longitudinal connecting member assembly having first and second bone anchors spanning between first and second vertebrae, the assembly comprising:
- a) a first elongate segment having an inner cord in continuous tension and having a steady state length, the cord being surrounded by at least one of a spacer and a blocker, the cord being in slideable relation with the first bone anchor; a second elongate segment attached to the second bone anchor; and
- b) a connecting structure capturing the second elongate segment, the connecting structure being in one of a fixed and a sliding relation with the tensioned cord, the connecting structure positioning the first elongate segment in an off-set and staggered relation with the second elongate segment.
16. The assembly of claim 15 wherein the second elongate segment is a hard rod fixed to the first bone anchor.
Type: Application
Filed: Apr 28, 2017
Publication Date: Aug 17, 2017
Inventor: Roger P. Jackson (Prairie Village, KS)
Application Number: 15/582,019