Bone anchors may be used in orthopedic surgery to fix bone during the healing or fusion process. In spinal surgery, bone anchors may be used with spinal fixation elements, such as spinal rods, to stabilize multiple vertebrae either rigidly, in which no relative motion between the vertebrae is desired, and dynamically, in which limited, controlled motion between the vertebrae is desired. One problem with the use of bone anchors is that bone anchors may pullout or otherwise be displaced from the bone prior to the healing or fusion process completing. This problem is particularly common when a bone anchor is positioned in poor quality bone such as osteoporotic bone. This problem is also common when a bone anchor is placed in the sacrum at the end of a spinal construct. The generally low strength of the sacrum and the moment arm exerted on the sacral anchor results in increased risk of pulling out the sacral anchor. Accordingly, there is need for improved bone anchors that minimize instances of such anchor pull out.
Disclosed herein are connectors for connecting a secondary bone anchor, such as a bone screw, with a primary bone anchor, such as a polyaxial screw for coupling a spinal rod to a vertebra. The use of a secondary bone anchor connected by the connector to the primary bone anchor can minimize instances of the primary bone anchor pulling out of bone.
In accordance with one exemplary embodiment, a connector for connecting a second bone anchor to a first bone anchor includes a first component engageable to the first bone anchor and rotatably adjustable relative to the first bone anchor, a second component connected to the first component and forming a socket to receive the second bone anchor in a plurality of angular orientations, and a closure mechanism engageable with the second component to fix the second bone anchor at a selected angular orientation relative to the second component.
These and other features and advantages of the devices and methods disclosed herein will be more fully understood by reference to the following detailed description in conjunction with the attached drawings in which like reference numerals refer to like elements through the different views. The drawings illustrate principles of the devices and methods disclosed herein and, although not to scale, show relative dimensions.
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
The terms “comprise,” “include,” and “have,” and the derivatives thereof, are used herein interchangeably as comprehensive, open-ended terms. For example, use of “comprising,” “including,” or “having” means that whatever element is comprised, had, or included, is not the only element encompassed by the subject of the clause that contains the verb.
The exemplary spinal fixation system 10 is particularly suited for sacral fixation to a patient's spine. As illustrated in
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The distal shaft 30 of the bone anchor 24 may be configured to engage bone and, in the illustrated embodiment, includes an external bone engaging thread 40. The thread form for the distal shaft 30, including the number of threads, the pitch, major and minor diameter, and thread shape, may be selected to facilitate connection with bone. Examples of exemplary thread forms are disclosed in U.S. patent application Ser. No. 13/110,378, filed May 18, 2011, which is incorporated herein by reference. Alternatively, the distal shaft 30 may include other structures for engaging bone, including a hook. The distal shaft 30 of the bone anchor 24 may be cannulated, having a central passage or cannula extending the length of the bone anchor to facilitate delivery of the bone anchor over a guide wire in, for example, minimally invasive procedures. The other components of the bone anchor assembly, including the closure member 26, the receiver member 22, and the compression member 50 (discussed below) may be cannulated or otherwise have an opening to permit the respective component to be delivered over a guide wire.
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The proximal end 32 of the receiving member 22 may be configured to receive a closure mechanism, such as an internal set screw (closure mechanism 26) or an external cap or nut. For example, the interior surface of each arm 34A, 34B may include a feature, such as a recess, dimple, notch, projection, thread or the like, to facilitate connection of the closure mechanism 26 to the receiver member 22. In the exemplary embodiment, for example, the interior surface of each arm 34A, 34B includes an internal thread 44 on the interior surface of each arm 34A, 34B for engaging the closure mechanism 26. In the exemplary embodiment, the thread starts at the free, proximal end and extends distally along at least a portion of the length of the arms 34A, 34B.
The closure mechanism 26 in the exemplary embodiment is an internal set screw having an external thread that engages the internal thread of the receiver member to capture a spinal fixation element within the recess 36 of the receiver member and, when fully tightened, to fix the spinal fixation element relative to the receiver member 22. Alternatively, the closure mechanism may be dual closure mechanism having an inner and an outer set screw, such as, for example, the Expedium Dual Innie Polyaxial Screw available from DePuy Spine, Inc. of Raynham, Mass. In addition, the closure mechanism may be a non-threaded twist-in cap, such as, for example, the Monarch Typhoon Cap available from DePuy Spine, Inc. of Raynham, Mass., and described in U.S. Pat. No. 6,755,829, incorporated herein by reference.
The exemplary primary bone anchor assembly 14 may be used with a spinal fixation element such as a rigid spinal rod 12. The spinal rod may be constructed from titanium, titanium alloys, stainless steel, cobalt chrome, PEEK, or other materials suitable for rigid fixation. Alternatively, the spinal fixation element may be a dynamic stabilization member that allows controlled mobility between the instrumented vertebrae.
The exemplary bone anchor assembly is a rigid polyaxial screw in which the primary bone anchor 14 is fixed, rather than mobile, when the spinal fixation element is fixed to the receiver member 22 of the primary bone anchor assembly 14. The spinal fixation element may either directly contact the proximal head 28 of the bone anchor 24 or may contact an intermediate element, e.g., a compression member 50, interposed between the spinal fixation element and the proximal head 28 of the bone anchor 24 to compress the distal outer surface of the proximal head 28 into direct, fixed engagement with the distal inner surface of the receiver member 22 when the spinal fixation element is fixed to the receiver member 22 of the primary bone anchor assembly 14 by the closure mechanism 26. In alternative embodiments, the primary bone anchor assembly may be a mobile screw in which the proximal head 28 of the bone anchor 24 can move relative to the receiver member 22 when the spinal fixation element is fixed to the receiver member 22. An exemplary mobile polyaxial screw is described is U.S. Patent Application Publication No. US 2011-0093021, which is hereby incorporated herein by reference. Alternatively, the bone anchor assembly may be a monoaxial screw, a favored angle screw or a uniplanar screw.
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In the exemplary embodiment, the first component 52 may be rotatably adjustable relative to the receiver member 22. In particular, the first component 52 is rotatably adjustable about the longitudinal axis 58 of the receiver member 22. The first component is generally ring shaped including a proximal ring 60 and an annular side wall 62 extending distally from the proximal ring 60. The annular side wall 62 may have an inner diameter sized to permit positioning of the first component 52 about the receiver member 22 of primary bone anchor assembly 22. The first component 52 includes a longitudinal axis 64 intersecting a center of the proximal ring 60. When the first component 52 is positioned about the receiver member 22 the longitudinal axis 64 if the first component 52 and the longitudinal axis 58 of the receiver member 22 are coincident.
The inner surface 66 of the annular side wall 62 of the first component 52 may include a pair of diametrically opposed, spaced apart projections 68A, 68B to facilitate connection and, subsequently, retention of the first component 52 to the receiver member 22 of the primary bone anchor assembly 14. Preferably, the projections 68A, 68B and the recesses 42A, 42B are complementary in shape to permit positioning of each projection 68A, 68B within a respective recess 42A, 42B and thereby inhibit axial motion of the first component 52 (e.g., motion parallel to the longitudinal axis 58 of the receiver member 22) relative to the receiver member 22 of the primary bone anchor assembly 14. In the exemplary embodiment, the projections 68A, 68B are arcuate in shape having a length sized to fit between the arms 34A, 34B of the receiver member 22. In this manner, the first component 52 may be oriented to position each projection 68A, 68B between the arms 34A, 34B of the receiver member 22, advanced distally, and rotated to position each projection 68A, 68B at least partially in a respective one of the recesses 34A, 34B. The rotational position of the first component 52 relative to the may be adjusted to orient the second component 54 at a desired position to accommodate the desired trajectory of the secondary bone anchor 16. In the exemplary embodiment, securing the closure mechanism 26 to the receiver member 22 fixes the rotational position of the first component 52 relative to the receiver member 22. In particular, rotation of the closure mechanism 26 into engagement with the internal thread 44 on the arms 42A, 42B may cause radially outward deflection or splay of the arms 42A, 42B. This outward deflection may create an interference between the outer surface of the receiver member 22 and the inner surface of the annular side wall 62 of the first component 52, thereby securing the rotational position of the first component 52 relative to the receiver member 22.
The proximal ring 60 preferably has a diameter that is less than the outer diameter of the receiver member 22 of the primary bone anchor assembly 14. In this manner, the distal surface 70 of the proximal ring 60 may engage the proximal surface of the receiver member 22 to inhibit axial motion of the first component 52 in the distal direction relative to the receiver member 22. The first component 52 may include one or more openings or the like to facilitate connection of an instrument to the first component 52. In the exemplary embodiment, the first component 52 includes a pair of diametrically opposed, spaced apart slots 72 in the annular side wall 62 for receiving projections from an instrument.
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The secondary bone 16 anchor includes a proximal head 86 and a bone engaging distal shaft 88 having one or more bone engaging threads. The proximal head 86 of the secondary bone anchor 16 in the exemplary embodiment is generally in the shape of a truncated sphere having a planar proximal surface and a generally spherically shaped distal surface 90. In the exemplary embodiment, the proximal head 86 of the secondary bone anchor 16 engages the socket 74 formed by the second component 54 of the exemplary connector 18 in a ball and socket like arrangement in which the proximal head 86, and thus the distal shaft 88, can pivot relative to the second component 54. The distal surface 90 of the proximal head 86 of the secondary bone anchor 16 and the mating surface of the within the socket 74 may have any shape that facilitates this ball and socket like arrangement, including, for example, spherical (as illustrated), toroidal, conical, frustoconical, and any combinations of these shapes. In this regard, the inner surface of the distal end wall 76 about the distal opening 78 may be generally spherical in shape. In the exemplary embodiment, the secondary bone anchor 16 can pivot through a cone of angulation centered about the longitudinal axis 84 of the socket 74.
The distal shaft 88 of the secondary bone anchor 16 may be configured to engage bone and, in the illustrated embodiment, includes an external bone engaging thread 92. The thread form for the distal shaft 88, including the number of threads, the pitch, major and minor diameter, and thread shape, may be selected to facilitate connection with bone. The thread form of the distal shaft 88 may be similar to the thread form of the distal shaft 30 of the bone anchor 2, discussed above.
The socket 74 formed by the second component 54 of the exemplary connector 18 may include an internal thread 94 proximal the proximal opening 82 for engagement with a complementary external thread provided on the second closure mechanism 56, which, in the exemplary embodiment, is an internal set screw. Referring to
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In use, the first component 52 of the connector 18 can be connected to the primary bone anchor assembly 14 after placement of the first bone anchor assembly 14 into bone, e.g. the sacrum, and positioning of a spinal rod 12 within the primary bone anchor assembly 14. The first component 52 can be rotated relative to the primary anchor assembly 14 to select the desired position for the second component 54 based on the desired trajectory for the second bone anchor 16. Once the desired rotational position is selected, the secondary bone anchor 16 may be positioned through the socket 74 of the second component 54 into bone, e.g., the sacrum. The second closure mechanism 56 can be connected to the second component 54 to secure the secondary bone anchor 16 relative to the socket 74. The first closure mechanism 26 can be connected to the primary bone anchor assembly 14 to secure to first component 52 of the connector 18 and the spinal rod 12 to the first bone anchor assembly 14 and to fix the position of the bone anchor 24 relative to the receiver member 22 of the first bone anchor assembly 14.
While the devices and methods of the present invention have been particularly shown and described with reference to the exemplary embodiments thereof, those of ordinary skill in the art will understand that various changes may be made in the form and details herein without departing from the spirit and scope of the present invention. Those of ordinary skill in the art will recognize or be able to ascertain many equivalents to the exemplary embodiments described specifically herein by using no more than routine experimentation. Such equivalents are intended to be encompassed by the scope of the present invention and the appended claims.
This application claims priority to U.S. Provisional Patent Application No. 61/541,213, filed Sep. 30, 2011, incorporate herein by reference.
Number | Date | Country | |
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61541213 | Sep 2011 | US |