Bone anchor with offset rod connector

Description

CROSS REFERENCES TO RELATED APPLICATIONS

The present application is a non-provisional application claiming the benefit of priority under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 61/888,480 filed on Oct. 8, 2013, the entire contents of which is hereby incorporated by reference into this disclosure as if set forth fully herein.

FIELD

The present application describes a bone anchor for use as part of a spinal fixation construct.

BACKGROUND

The spine is formed of a column of vertebra that extends between the cranium and pelvis. The three major sections of the spine are known as the cervical, thoracic and lumbar regions. There are 7 cervical vertebrae, 12 thoracic vertebrae, and 5 lumbar vertebrae, with each of the 24 vertebrae being separated from each other by an intervertebral disc. A series of about 9 fused vertebrae extend from the lumbar region of the spine and make up the sacral and coccygeal regions of the vertebral column.

The main functions of the spine are to provide skeletal support and protect the spinal cord. Even slight disruptions to either the intervertebral discs or vertebrae can result in serious discomfort due to compression of nerve fibers either within the spinal cord or extending from the spinal cord. If a disruption to the spine becomes severe enough, damage to a nerve or part of the spinal cord may occur and can result in partial to total loss of bodily functions (e.g., walking, talking, breathing, etc.). Therefore, it is of great interest and concern to be able to treat and correct ailments of the spine.

When conservative efforts fail, treating spinal ailments very often includes a combination of spinal fusion and fixation. Generally, spinal fusion procedures involve removing some or all of an intervertebral disc, and inserting one or more intervertebral implants into the resulting disc space. Introducing the intervertebral implant serves to restore the height between adjacent vertebrae (“disc height”) and maintain the height and/or correct vertebral alignment issues until bone growth across the disc space connects the adjacent vertebral bodies. Fusions may be performed across a single level or multiple levels.

Often during spinal fusion procedures a posterior fixation construct is implanted to immobilize the vertebrae to be fused until the fusion is complete. The posterior fixation construct generally includes at least two bone anchors (e.g. pedicle screws, laminar hooks) connected together with a rod. Like the fusion, the fixation construct can be implanted across a single level or across multiple levels, and typically, the fixation system is positioned to at least span each level to be fused. These pedicle screw systems are very effective. However, there can also be challenges associated with them. For example, connecting the rod to each anchor can be difficult since the anchors are not necessarily coplanar. When this happens the rod must be bent to match the position of the anchor, or the entire vertebra must be moved to move the anchor to the rod. There are also instances when the position of the rod and/or the connecting portion of the anchor can obstruct access to spine in close proximity to the anchor.

The devices and methods described in the present application are directed at address these challenges.

BRIEF DESCRIPTIONS OF THE DRAWINGS

Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:

FIG. 1 is a top view of a bilateral spinal fixation construct utilizing a quartet of offset bone anchor assemblies, according to an example embodiment;

FIG. 2 is a perspective view of an offset bone anchor assembly, according to one example embodiment;

FIG. 3 is an exploded view of the offset bone anchor assembly of FIG. 2;

FIG. 4 is a cross-sectional view of the offset bone anchor assembly of FIG. 2;

FIG. 5 is a cross-sectional view of the offset bone anchor assembly of FIG. 2, wherein the cross-section extends through a tulip of the bone anchor assembly;

FIG. 6 is another perspective view of the offset bone anchor assembly of FIG. 2;

FIG. 7 is a perspective view of a connector of the bone anchor assembly of FIG. 2;

FIG. 8 is a perspective view of a base of the connector of FIG. 7;

FIG. 9 is another perspective view of a base of the connector of FIG. 7;

FIG. 10 is a perspective view of a tulip of the connector of FIG. 7;

FIG. 11 is another perspective view of the tulip of the connector of FIG. 7;

FIG. 12 is another perspective view of the tulip of the connector of FIG. 7 shown without a compressible member that is situated within the tulip;

FIG. 13 is another perspective view of the tulip of the connector of FIG. 7 shown without the compressible member;

FIG. 14 is a perspective view illustrating two of the offset bone anchor assemblies of FIG. 2 coupled together by a laterally offset spinal rod;

FIG. 15 is a perspective view illustrating one of the offset bone anchor assemblies of FIG. 2 coupled together with a polyaxial screw by a spinal rod medially offset from the offset bone anchor assembly;

FIGS. 16A-16E are top view illustrations depicting certain steps of an example method for constructing the bilateral fixation construct of FIG. 1;

FIGS. 17-18 are lateral and axial views of a vertebra depicting one example of a medialized trajectory for implanting the bone anchors according the example method of FIGS. 16A-1E; and

FIG. 19 is a perspective view illustrating one of the offset anchor assemblies of FIG. 2 fixed to the ilium at the caudal end of a fixation construct, the cephalad anchor location being offset medially relative to the ilium anchor locations.

FIGS. 20-21 illustrate perspective views of another example embodiment of an offset bone anchor assembly; and

FIG. 22 is a front view of the bone anchor assembly of FIGS. 20-21.

DETAILED DESCRIPTION

Preferred embodiments of devices and techniques for spinal fixation are described herein. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The spinal fixation anchor and methods described herein boast a variety of inventive features and components that warrant patent protection, both individually and in combination.

With reference to FIG. 1, a single level, bilateral spinal fixation construct utilizing a quartet of offset bone anchor assemblies 10 is depicted. More specifically, a first anchor assembly 10A is anchored through the pedicle P1 of lumbar vertebrae V1 and a second anchor assembly 10B is anchored through the contralateral pedicle P2 of V1. A third anchor assembly 10C is anchored through the pedicle P3 of lumbar vertebra V2 adjacent to V1, and a fourth anchor assembly 10D is anchored through pedicle P4 of V2. The anchor assemblies 10A and 10C are connected by a spinal rod 24A and the anchor assemblies 10B and 10D are connected by the spinal rod 24B in order to fix the vertebrae V1 and V2 in position relative to each other. The anchor assemblies 10A-10D include a rod connector that is offset and adjustable with respect to position relative to the shank, in effect, de-coupling the rod position from the shank position. Accordingly, the shank can be placed in the desired location (e.g. pedicle) while the position of the rod connector and rod can be adjusted to accommodate other surgical considerations (e.g. anatomical obstructions, clearance for other implants, grafts, etc. . . . ). By way of example, in the configuration shown, the anchor assemblies 10A-10D are implanted using a medialized trajectory, that is, with a starting point that is more medial to that of a standard pedicle screw starting point (e.g. the starting point may be just medial and inferior to the articulating surface of the superior facet) and angled slightly laterally such that the distal end of the shank lies lateral to the proximal end of the shank at the starting point, and preferably anchored into the cortical bone along the periphery of the vertebral body. The rod position however is offset laterally from the shank which affords a greater opportunity between the shanks for the medial placement of graft material, spinous process plates, or other fusion and fixation elements. In alternative configurations, the offset anchor 10 may be used to achieve a medial offset (e.g. for connecting a construct to the ilium (FIG. 19)) and/or various other anchor types (e.g. standard polyaxial screws, fixed screws, hooks, etc. . . . ) may be used at other anchor locations with one or more offset anchors 10 to achieve the desired fixation construct.

FIGS. 2-13 illustrate an example embodiment of the offset bone anchor assembly 10 that may be used in at least one anchor position along a fixation construct. The anchor assembly 10 includes a shank 12 configured to anchor in bone and a rod connector 14 coupleable to the shank 12 and coupleable to a fixation rod 24. The shank 12 includes a spherical head 26, a neck 28, and a threaded shaft 30. The head 26 includes an engagement recess 32 formed therein that is configured to engage with a suitable driver instrument (not shown). The neck 28 is a generally smooth (e.g. non-threaded) surface extending circumferentially around the bone anchor shank 12 and having a diameter smaller than the diameter of the head 26. The threaded shaft 30 extends distally from the neck 28 and may be any length suitable to achieve the desired bone purchase. As pictured, the threaded shaft 30 employs a triple zoned thread pattern that is designed to maximize purchase with a medialized screw trajectory. The shank 12 may be cannulated to allow for insertion of the shank 12 over a k-wire or other guide instrument, or the shank may be non-cannulated.

The rod connector 14, shown in FIG. 7, includes a base 18 that couples to the shank 12 and a tulip 16 that receives the rod 24. The base 18 further includes a receptacle 34 with an aperture 36 extending axially therethrough and an arm 46 extending from the receptacle 34 perpendicularly to a longitudinal axis of the aperture 36. The aperture 36 has an upper threaded pocket 38 and a conically tapered lower pocket 40. A cylindrical collet 42 having a plurality of flexible fingers 44 is situated within the lower pocket 40 and a spherical pocket 45 within the collet 42 is configured to receive the spherical head 26 of the shank 12. The anchor locking cap 22 is advancable through the threaded upper pocket 38 into engagement with the collet 42 and forces the collet 42 deeper into the lower pocket 40 such that the flexible fingers 44 are directed inwards as they advance along the conical taper 39. Thus, when the shank head 28 is captured within the spherical pocket 45 of the collet 42 and the anchor locking cap 22 is engaged, the flexible fingers 44 collapse inwards and close about the spherical head 26, locking the connector 14 to the shank 12 and fixing the position of the base 18 relative to the shank. Prior to locking, the spherical head 26 can rotate within the spherical pocket 45 of the collet 42 such that the base 18 is polyaxially coupled to the shank 12. According to one example, in use the shank 12 may be anchored into the vertebra first, free of the connector 14. Thereafter, the receptacle 34 can be advanced onto the shank 12 until the shank head 26 rests in the spherical pocket 45 of the collet 42.

With reference to FIGS. 8-9, the arm 46 of base 18 has an upper surface 50 and a lower surface 52 which are separated by sidewalls 54 and endwall 56 such that the arm has a length L1 between the endwall 56 and the receptacle 34, a height H1 between the upper surface 50 and lower surface 52, and a width W1 between the sidewalls 54. The tulip 16 slidably and rotatably couples to the arm 46 and a pin 58, which may be press fit, welded, or otherwise securely engaged in a hole 60 adjacent the endwall 56 maintains the tulip 16 on the arm 46 after assembly.

FIGS. 10-13 illustrate the tulip 16. The tulip 16 includes a pedestal 62 and a pair of upstanding arms 64 extending from the pedestal and separated by a rod channel 66. The pedestal 62 defines a passage 68 through which the arm 46 is situated. The passage 68 runs perpendicular to the rod channel 66 such that a rod captured in the tulip will lie transverse to the arm length L1 and offset from the shank 12. A spherical compression element 70 situated within the passage 68 includes an upper compression element 72 and a lower compression element 74. The lower compression element has a spherical lower surface that rests in a spherical cavity 76 in the passage floor and a planar upper surface that contacts the lower surface 52 of the arm 46. The upper compression element 72 has a spherical upper surface that rests in a spherical cavity 78 on the underside of the load ring 80 upon which the rod 24 sits and a planar lower surface that contacts the upper surface 50 of the arm 46. The lower surface of the upper compression element 72 can slide along the upper surface 50 of the arm and the upper surface of the lower compression element 74 can slide along the lower surface 52 of the arm 46 such the compression element 70 can translate along the arm 46 to adjust the position of the tulip along the length of the arm 46 and relative to the shank 12. The tulip 16, via spherical cavity 76 and spherical cavity 78, can also rotate around the spherical compression element 70 such that the tulip 16 can rotate about the arm 46. The passage 68 through pedestal 62 includes a height H2 that is greater than the arm height H1 and a width W2 that is greater than the arm width W1 such that the rotation around the compression element 70 is permitted in all direction to a limited extent. Similarly, the passage has a length L2 that is less than the arm length L1 so that the tulip 16 can translation along the arm 46.

The upstanding arms 64 are equipped with a guide and advancement feature 82, such as by way of example, a helically wound flange feature disposed on the interior face of each arm 64. The guide and advancement feature 82 mates with a complementary guide and advancement feature 84 on the rod locking cap 20 (FIG. 3). The upstanding arms also include an engagement feature 85 that provides an attachment point for coupling the tulip 16 to various instruments that may be used during the procedure (e.g. a rod reduction instrument, compressor, distractor, etc. . . . ). The load ring 80 has a concave, semi-cylindrical upper surface 88 that forms a cradle to receive the spinal rod 24. As the rod locking cap 20 engages the upstanding arms 64 via the complementary guide and advancement features 82, 84, the locking cap forces the rod 24 down into the load ring 80 which in turn presses down against the upper compression element 72. The upper compression element presses down against the arm 46 which loads the lower compression element against the pedestal. Fully engaging the rod locking cap 20 seizes the mechanism and locks the position and orientation of the tulip relative to the arm 46, and thus too, to the shank 12.

With reference to FIG. 14-15, the offset anchor assembly 10 described above can be utilized in any number of ways and configurations when constructing a spinal fixation construct. By way of example, FIG. 14 depicts a pair of offset anchor assemblies 10 used at each end of a single level construct with the tulips 16 offset laterally. As previously noted this configuration may be particularly useful when applied in a medialized posterior fusion surgery wherein anchors are medialized, as will be described below, or by way of another example, for fusion of the posterior elements and spinous process fixation. FIG. 15 depicts a construct in which a single offset anchor assembly 10 is used at the caudal end of a single level construct and the tulip offset medially. A regular polyaxial pedicle screw 90 is used at the caudal end of the construct. This configuration may be useful for example, to fix the cephalad end of the construct to the ilium where the desired anchor location lies more lateral than the spinal levels above it. This is depicted, for example in FIG. 19. Additionally, the offset anchor 10 may be used at any one or more anchor locations of a multilevel construct and offset medially or lateral depending on the goal to be achieved.

Now with reference to FIGS. 16A-16E, a preferred method for employing anchor assembly 10 with a spinal fixation construct is described. First, after the affected spinal level is identified, a midline incision is made and the necessary anatomy, including pedicles P1 and P2 of vertebrae V1 and pedicles P3 and P4 of vertebra V2, is exposed. A tissue retractor may be employed to maintain access to the exposed spinal anatomy and hold tissue out of the operative corridor. Next, and with reference to FIG. 16A, a shank is anchored into each pedicle. For example, a first shank 12A is anchored through pedicle P1, a second shank 12B is anchored through pedicle P2, a third shank 12C is anchored through pedicle P3, and a fourth shank 12D is anchored through the pedicle P4. The shanks 12A-12D are implanted along a medialized trajectory, which is depicted by way of example as trajectory T_M in FIGS. 17-18. The medialized trajectories between the shanks anchored in the same vertebra (e.g. 12A-12B in V1 and 12C-12D in V2) diverge and may also be directed slightly superiorly. Inserting screws along this trajectory generally allows for placement of a shorter screw shank than those placed along traditional trajectories because the medialized trajectory takes advantage of the anatomical location of cortical bone within the vertebral body. Once the shanks 12A-12D are inserted any therapy to be performed on the spine (e.g. decompression, discectomy, interbody implant insertion, etc. . . . ) may be completed. Then, as illustrated in FIG. 16B, the base 18A of rod connector 14A is coupled to the head of shank 12A with the tulip 16A offset laterally to the shank. The connector may be rotated about the shank head until the desired position is achieved and then the anchor locking cap 22 is engaged to lock the connector. 14A relative to the shank 12A. These steps are repeated for each additional rod connector 14B-14D, as shown in FIG. 16C. Coupling the rod connectors after performing the therapy on the spine allows for more space within the surgical exposure to operate on the spine and perform the desired therapy as there is less hardware present during the procedure. Turning to FIG. 16D, once the connectors 14A-D are coupled to their respective shanks 12A-d, a first rod 24A is inserted into position to connect tulips 16A and 16C and a second rod 24B is inserted into position to connect tulips 16B and 16C. To facilitate rod capture, the tulips 16 can translate along the base arm 46 and/or rotate relative to the arm 46 to adjust the position and orientation of the tulip. With the rods 24A-24B appropriately situated, the rod locking caps 20A-20D are fully engaged in the tulips to complete the construct, as shown in FIG. 16E, arresting any further movement of the tulips and fixing the position of vertebra V1 and Vertebra V2 relative to each other.

FIGS. 20-22 illustrate a second example embodiment of an offset anchor assembly 10′ to be utilized at least one anchor location of a spinal fixation construct. The offset connector 10′ includes a shank 12′ and connector 14′ that further includes a tulip 16′ and base 18′. The shank 12′ and base 18′ are identical to the shank 12 and base 18 previously described. The tulip 16′ is also identical to the tulip 16, except in that the passage 68′ 68 runs parallel to the rod channel 66′ such that a rod captured in the tulip 16′ will lie generally in line with the arm length. Under typical circumstances in this configuration the offset of the tulip becomes one of a cranial or caudal offset as opposed to the medial or lateral offset provided by anchor assembly 10.

It is further contemplated that the compressible member 70 of anchor assembly 10 or compressible member 70′ of anchor assembly 10′ may be configured such that when the rod locking cap is fully engaged, the compressible member provides resistance against movement, but does arrest movement entirely. Or alternatively, the compressible member will resist all movement up to a certain force, above which the compressible member will give and some movement will be achieved. In effect, the provides for a semi-rigid connection that provides controlled motion in that tulip (and thus the rod captured within the tulip) has some freedom to translate and/or rotate relative to the arm which can accommodate natural shifting and/or realignment pressure that may occur after the construct is completed. It is believed that this ability to accommodate some degree of controlled movement, particularly with the anchor assembly 10 or 10′ positioned at the end of a construct, an especially a long construct, may have beneficial effects in preventing the development of adjacent segment pathology like Proximal Junctional Kyphosis (PJK) which is thought to possibly be caused by excess strain and stress on the proximal instrumented spinal segment which is then at least partially transferred to the bone structures, disc, ligaments and other soft tissues, causing a loss of normal structural integrity and mechanical properties.

While specific embodiments have been shown by way of example in the drawings and described herein in detail, it will be appreciated that the invention is susceptible to various modifications and alternative forms (beyond combining features disclosed herein). The description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.