US20200054365A1 - Stabilizing Bone Using Spinal Fixation Devices and Systems - Google Patents

Abstract

In one embodiment, the present invention includes a bone fixation assembly comprising a coupling element and a bone anchor. The coupling element has an upper surface with a first diameter defining a first bore extending along a first axis, a lower surface with a second diameter defining a second bore extending along a second axis, and an internal surface area defining a seating portion adjacent to the lower surface. The bone anchor has an insertion end opposite of a head. The head may be curved for receipt within the seating portion. The first diameter of the first bore is greater than the second diameter of the second bore. Likewise, the first and second axes may intersect such that the first and second bores are in communication with one another. Related elements and systems of this assembly are also disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 15/498,190 filed Apr. 26, 2017, which is a continuation of U.S. patent application Ser. No. 14/496,652 filed Sep. 25, 2014, which is a continuation of U.S. patent application Ser. No. 13/934,819 filed Jul. 3, 2013, which is a continuation of U.S. patent application Ser. No. 12/012,434 filed Feb. 1, 2008, which is a continuation of U.S. patent application Ser. No. 10/832,214 filed Apr. 26, 2004, which is a divisional of U.S. patent application Ser. No. 10/091,068 filed Mar. 5, 2002, which claims the benefit of the filing date of U.S. Provisional Application No. 60/322,042, filed Sep. 14, 2001, the disclosures of which are each hereby incorporated by reference herein.
FIELD OF THE INVENTION
• The present invention relates generally to spinal fixation devices and more specifically relates to pedicle fixation assemblies.
BACKGROUND OF THE INVENTION
• The spinal column is a highly complex system of bones and connective tissues that provides support for the body and protects the delicate spinal cord and nerves. The spinal column includes a series of vertebral bodies stacked one atop the other, each vertebral body including an inner or central portion of relatively weak cancellous bone and an outer portion of relatively strong cortical bone. Situated between each vertebral body is an intervertebral disc that cushions and dampens compressive forces exerted upon the spinal column A vertebral canal containing the spinal cord and nerves is located behind the vertebral bodies.
• There are many types of spinal column disorders including scoliosis (abnormal lateral curvature of the spine), kyphosis (abnormal forward curvature of the spine, usually in the thoracic spine), excess lordosis (abnormal backward curvature of the spine, usually in the lumbar spine), spondylolisthesis (forward displacement of one vertebra over another, usually in a lumbar or cervical spine) and other disorders caused by abnormalities, disease or trauma, such as ruptured or slipped discs, degenerative disc disease, fractured vertebra, and the like. Patients that suffer from such conditions usually experience extreme and debilitating pain, as well as diminished nerve function.
• Surgical techniques commonly referred to as spinal fixation uses surgical implants for fusing together and/or mechanically immobilizing two or more vertebral bodies of the spinal column. Spinal fixation may also be used to alter the alignment of adjacent vertebral bodies relative to one another so as to change the overall alignment of the spinal column. Such techniques have been used effectively to treat the above-described conditions and, in most cases, to relieve pain.
• There are many disadvantages associated with current spinal fixation devices.FIG. 1 show a prior art bone fixation device that is incapable of capturing spine rods when the rod capturing assemblies must be rotated to extreme angles. The design limits pivotal movement to an angle θ.
• One spinal fixation technique involves immobilizing the spine using orthopedic stabilizing rods, commonly referred to as spine rods, which run generally parallel to the spine. This may be accomplished by exposing the spine posteriorly and fastening bone screws to the pedicles of vertebral bodies. The pedicle screws are generally placed two per vertebra and serve as anchor points for the spine rods. Clamping elements adapted for receiving a spine rod therethrough are then used to join the spine rods to the pedicle screws. The aligning influence of the spine rods forces the spinal column to conform to a more desirable shape. In certain instances, the spine rods may be bent to achieve the desired curvature of the spinal column.
• U.S. Pat. No. 5,129,388 to Vignaud et al. discloses a spinal fixation device including a pedicle screw having a U-shaped head rigidly connected to an upper end of the screw. The U-shaped head includes two arms forming a U-shaped channel for receiving a spine rod therein. The U-shaped head is internally threaded so that a setscrew having external threads may be screwed therein. After the pedicle screw has been inserted into bone and a spine rod positioned in the U-shaped channel, the set screw is threaded into the internal threads of the U-shaped channel for securing the spine rod in the channel and blocking relative movement between the spine rod and the pedicle screw. The fixation device also includes a cap covering an upper portion of the U-shaped head to prevent the arms from spreading apart as the set screw is threaded into the internal threads of the U-shaped head.
• Surgeons have encountered considerable difficulty when attempting to insert spinal fixation devices such as those disclosed in the above-mentioned '388 patent. This is because the U-shaped heads atop adjacent screws are often out of alignment with one another due to curvature of the spinal column and the different orientation of adjacent pedicles receiving the screws. As a result, spine rods must often be bent in multiple planes in order to pass the rods through adjacent U-shaped channels. This “bending the spine rod” solution serves to weaken the strength of the assembly and results in significantly longer operations, which increases the likelihood of surgical complications.
• In response to the above-noted problems, U.S. Pat. No. 5,733,286 to Errico et al., U.S. Pat. No. 5,672,176 to Biedermann et al., and U.S. Pat. No. 5,476,464 to Metz-Stavenhagen disclose polyaxial spinal fixation devices wherein the anchoring element fixed to the bone has a spherically-shaped head. The fixation devices in the above-identified patents also have orthopedic rod capturing assemblies for securing orthopedic rods in the capturing assemblies and connecting the rods with the anchoring elements. The spherically shaped heads of the anchoring elements permit movement of the rod capturing assemblies relative to the anchoring elements.
• In spite of the above-mentioned devices, there remains a need for improved spinal fixation devices. In particular, there remains a need for spinal fixation devices that provide an increased degree of angulation between the rod capturing assemblies and the anchoring elements so as to facilitate capturing orthopedic stabilizing rods within the rod capturing assemblies.
SUMMARY OF THE INVENTION
• In one preferred embodiment of the present invention, a fixation assembly includes a coupling element having a first section with a first bore coaxial with a first longitudinal axis and a second section with a second bore coaxial with a second longitudinal axis transverse to the first longitudinal axis. The first bore extends from an upper end of the coupling element and the second bore extends from the lower end of the coupling element. The coupling element also includes rod-receiving openings extending from the upper end thereof. The fixation assembly anchoring element having a first end for insertion into bone and a longitudinal axis. The first and second bores of the coupling element extend in directions that are tilted with respect to one another, as their associated first and second longitudinal axes are disposed transversely to one another. Due to the biased angulation of the coupling element, the coupling element can be manipulated to cover a broader range of angles for capturing an orthopedic stabilizing rod.
• In certain preferred embodiments, the anchoring element is integrally connected to a lower end of the coupling element. In other preferred embodiments, the anchoring element comprises a separate member assembled with the coupling element, whereby the coupling element and anchoring element are pivotable and rotatable relative to one another for capturing a spine rod in the rod receiving openings of the coupling element.
• Achieving sufficient angulation between anchoring elements while engaging the orthopedic rod is essential for assemblies mounted in spines having abnormal curvatures. Sufficient angulation is also important in the cervicothoracic junction of the spine.
• After being assembled together, the coupling element and the anchoring element are preferably pivotable and rotatable relative to one another. The coupling element preferably includes a seat adjacent the lower end thereof that is shaped to facilitate pivotal movement of the coupling element and anchoring element relative to one another.
• In certain preferred embodiments, the seat is shaped to allow the coupling element to pivot with respect to the anchoring element. Before the coupling element is locked into place with respect to the anchoring element, the coupling element is pivotable and rotatable for capturing a spine rod in the rod receiving openings thereof. The combination of the pivotable coupling element and the tilted arrangement of the first and second portions of the coupling element enable the coupling element to move over a broader range of angles for capturing a spine rod.
• The anchoring element preferably has a second end remote from the first end, and a head at the second end having an underside for engaging the seat. The assembly preferably includes a locking element engageable with the coupling element for locking the rod in the coupling element, after the rod has been received in the rod-receiving openings. The locking element forces the head against the seat of the coupling element to lock the position of the coupling element with respect to the anchoring element.
• The head may have a depression adapted to receive a driver for driving the anchoring element into bone. The depression in the head may be one or more slots or a hexagonal opening. The anchoring element may include a neck between the head and the first end thereof. The neck preferably has a reduced diameter portion for facilitating pivotal movement of the coupling element and the anchoring element relative to one another. The reduced diameter neck may have a concave surface located adjacent an underside of the head.
• The head and seat may have many shapes. In certain preferred embodiments, the head has an underside with a convex shape for engaging the seat. The seat may be defined by an interior wall of the coupling element having an inwardly tapering conical shape. In other preferred embodiments, the seat may be defined by an interior wall of the coupling element having a convex or spherical shape.
• The coupling element preferably has an exterior surface, an upper end and a lower end, and rod-receiving openings that are open on the upper end and extend toward the lower end. The coupling element preferably has cuts formed between the exterior surface and the rod-receiving openings for minimizing the width of the coupling element. As a result, adjacent coupling elements may be more closely packed adjacent one another, because the cuts result in the coupling elements having less width.
• In certain preferred embodiments, the anchoring element is a screw fastener having screw threads extending between the first and second ends thereof. The anchoring element may include barbs on an outer surface thereof so that withdrawal of the anchoring element from bone is hindered by the barbs. The anchoring element may also include an elongated shaft having holes defined therein for receiving bone graft material or allowing ingrowth of bone. The anchoring element may also include a hook for anchoring into bone.
• The coupling element may include a chamfer adjacent the first bore for facilitating assemblies of the anchoring element with the coupling element. The coupling element may have opening surfaces defining the rod receiving openings and the chamfer may extend from one of the opening surfaces to an inner surface defining the first bore.
• In another preferred embodiment of the present invention, a bone fixation assembly includes a coupling element having an upper end defining a first plane and having rod receiving openings, a lower end defining a second plane that intersects the first plane, and at least one bore extending between the upper and lower ends. The at least one bore is adapted to receive an anchoring element. The assembly includes an anchoring element having a first end insertable into bone that is assembled with the coupling element.
• The head of the anchoring element preferably has one or more depressions formed therein adapted for receiving a driver for driving the anchoring element into bone. The anchoring element preferably includes a reduced diameter neck for facilitating pivotal movement of the coupling element with respect to the anchoring element.
• In further preferred embodiments of the invention, a coupling element has an upper end and a lower end and comprises a first section extending from the upper end toward the lower end of the coupling element. The first section has a first bore coaxial with a first longitudinal axis. The coupling element has a second section extending from the lower end toward the upper end of the coupling element. The second section has a second bore coaxial with a second longitudinal axis transverse to the first longitudinal axis. As a result, the first and second bores extend in directions that are angled relative to one another. The coupling element includes rod-receiving openings extending from the upper end toward the lower end that are adapted to receive an orthopedic rod.
• The inner surface of the coupling element adjacent upper end preferably includes threads for engaging external threads on a locking element for locking an orthopedic rod with the coupling element. The locking element is threaded into the internal threads of the coupling element after spine rod has been captured in rod receiving openings.
• In certain preferred embodiments, the coupling element has an outer surface with gripping notches for engagement by an instrument so that the coupling element may be positioned with respect to an orthopedic rod. The notches may include indentations or protrusions provided therein for centering the instrument on the coupling element.
• In still another preferred embodiment of the present invention, a coupling element for a pedicle screw assembly comprises an upper end defining a first plane, a lower end defining a second plane, and at least one bore extending between the upper and lower ends adapted to receive an anchoring element. The first and second planes intersect one another. The first plane and the second plane preferably have an intersection defining an angle of about 20-30°. In more preferred embodiments, the angle between the first and second intersecting planes is about 25°±2°. In highly preferred embodiments, the angle between the intersecting planes is approximately 24°.
• In yet another preferred embodiment of the present invention, a coupling element for a pedicle screw assembly includes a first section at an upper end of the coupling element, the first section having a first bore coaxial with first longitudinal axis, and a second section at a lower end of the coupling element, the second section having a second bore coaxial with a second longitudinal axis. The first and second longitudinal axes preferably intersect one another. The assembly includes an anchoring element, such as a screw thread. The bone anchoring portion of the anchoring element is adapted to project through the second bore opening at the lower end of the coupling element when the coupling element and anchoring element are assembled together.
• In still another preferred embodiment of the present invention, a method of stabilizing bone, such as an area of the spine, includes anchoring an anchoring element into bone. The anchoring element is assembled with a coupling element having first and second sections that are angled relative to one another. In one preferred embodiment, the anchoring element has a first bore and a second bore that are tilted with respect to one another. The anchoring element projects through the second bore opening at a lower end of the coupling element so that the coupling element and anchoring element are movable relative to one another. The position of the coupling element is adjustable with respect to the anchoring element so that rod receiving openings extending from an upper end of the coupling element may receive an orthopedic rod. After the rod is captured in the rod-receiving openings, the position of the coupling element is locked with respect to the anchoring element using a locking element that exerts a downward locking force on the spine rod, which in turn forces the head of the anchoring element into the seat of the coupling element.
• The coupling element desirably has the first bore extending through the first section and the second bore extending through the second section. The anchoring element and coupling element are preferably assembled by inserting the anchoring element into the first bore.
• Before the coupling element and anchoring element are locked, the position of the coupling element may be adjusted by pivoting the coupling element with respect to the anchoring element so that the rod receiving openings engage an orthopedic rod disposed at a position displaced from the longitudinal axis of the anchoring element.
• In another preferred embodiment of the present invention, a method of stabilizing bone includes providing a coupling element having first and second sections that are angled relative to one another, the coupling element having rod receiving openings for receiving an elongated member, assembling the coupling element with an anchoring element, and after the assembling step, securing the anchoring element in bone. The method includes moving the coupling element relative to the anchoring element to align the rod receiving openings with the elongated member, securing the orthopedic rod in the rod receiving openings, and after the securing step, locking the coupling element from further movement relative to the anchoring element.
• In still another preferred embodiment of the present invention, a method of stabilizing an area of the spine includes providing a coupling element having a first bore coaxial with a first longitudinal axis and a second bore coaxial with a second longitudinal axis, whereby the first and second longitudinal axes are transverse to one another. The method includes assembling the coupling element with an anchoring element, and after the assembling step, securing the anchoring element in bone. The coupling element desirably has rod receiving openings for securing an orthopedic rod. The method also preferably includes moving the coupling element relative to the anchoring element to align the rod receiving openings with the orthopedic rod, securing the orthopedic rod in the rod receiving openings, and after the securing step, locking the coupling element from further movement relative to the anchoring element.
• In yet another preferred embodiment of the present invention, a method of stabilizing a spine includes providing a coupling element having an uppermost end defining a first plane, a lowermost end defining a second plane, and at least one bore extending from the uppermost end toward the lowermost end, whereby the first and second planes intersect one another. The method desirably includes assembling the coupling element with an anchoring element, and after the assembling step, securing the anchoring element in bone. The method may also include moving the coupling element relative to the anchoring element to align rod receiving openings of the coupling element with an orthopedic rod, securing the orthopedic rod in the rod receiving openings, and after the securing step, locking the coupling element from further movement relative to the anchoring element.
• These and other preferred embodiments of the present invention will be described in more detail below.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other objects, features and advantages of the present invention will be more readily apparent from the detailed description of preferred embodiments set forth below, taken in conjunction with the accompanying drawings, in which:
• FIG. 1 shows a side elevation view of a prior art bone fixation assembly.
• FIG. 2 shows a simplified view of a pair of bone fixation assemblies coupled with an orthopedic stabilizing rod, in accordance with certain preferred embodiments of the present invention.
• FIG. 3 is a top plan view of a coupling element of a bone fixation assembly, in accordance with a preferred embodiment of the present invention.
• FIG. 4 is a left side elevation view of the coupling element ofFIG. 3.
• FIG. 5 is a front elevation view of the coupling element ofFIGS. 3-4.
• FIG. 6 is a perspective view of the coupling element ofFIGS. 3-5.
• FIG. 7 is a cross-sectional view of the coupling element ofFIG. 5 taken along line7-7 thereof.
• FIG. 8 is a front elevation view of an anchoring element, in accordance with certain preferred embodiments of the present invention.
• FIG. 9 is a top plan view of the anchoring element ofFIG. 8.
• FIG. 10 is a right side elevation view, partially in section, of the anchoring element ofFIGS. 8-9 partially assembled with the coupling element ofFIGS. 3-7.
• FIG. 11 is a right side elevation view, partially in section, of the coupling element and anchoring element ofFIG. 10 during a further assembly step.
• FIG. 12 is a right side elevation view, partially in section, of the coupling element and anchoring element ofFIG. 11, whereby the anchoring element is fully seated in the coupling element.
• FIG. 13 is a right side elevation view, partially in section, of the coupling element and anchoring element ofFIGS. 10-12, with the anchoring element secured in bone.
• FIG. 14 is a right side elevation view, partially in section, of the coupling element and anchoring element ofFIG. 13, with the coupling element pivoted about a head of the anchoring element.
• FIG. 15 is a right side elevation view, partially in section, of the bone fixation assembly ofFIG. 14 with a spine rod captured in the coupling element and held in place by a locking element.
• FIG. 16 is a front elevation view, partially in section, of the coupling element, anchoring element, of locking element and spinal rod shown inFIG. 16.
• FIG. 17 is a cross-sectional view of an anchoring element of a bone fixation assembly, in accordance with another preferred embodiment of the invention.
• FIG. 18 is a perspective view of a coupling element of a bone fixation assembly, in accordance with another preferred embodiment of the present invention.
• FIG. 19 is a right side elevation view of the coupling element ofFIG. 18.
• FIG. 20 is a top plan view of the coupling element ofFIGS. 18-19.
• FIG. 21 is the cross-sectional view of the coupling element ofFIG. 20 taken along line21-21 inFIG. 20.
• FIG. 22 is the cross-sectional view of the coupling element ofFIG. 21 taken along line22-22 inFIG. 21.
• FIG. 23 is an elevation view of two bone fixation assemblies secured to a stabilizing rod, in accordance with preferred embodiments of the present invention.
• FIG. 24 is a perspective view of the two bone fixation assemblies ofFIG. 23.
• FIG. 25 is a perspective view of a coupling element of a bone fixation assembly, in accordance with further preferred embodiments of the present invention.
• FIG. 26 is a cross sectional view of the coupling element ofFIG. 25.
• FIG. 27 is a top view of the coupling element ofFIG. 26 taken along axis B-B thereof.
• FIGS. 28A and 28B show respective top plan and side elevation views of a blank used to make a coupling element of a bone fixation assembly, in accordance with certain preferred embodiments of the present invention.
• FIG. 29 shows a front elevation view of a coupling element, in accordance with certain preferred embodiments of the present invention.
• FIG. 30 shows a top plan view of the coupling element ofFIG. 29 along axis A-A thereof.
• FIG. 31 shows a side elevational view of the coupling element ofFIG. 29.
• FIG. 32A shows a top plan view of the coupling element ofFIG. 31 along axis B-B thereof.
• FIG. 32B shows a cross-sectional view of the coupling element ofFIG. 32A taken alongline32B-32B thereof.
• FIG. 32B-1 shows an expanded view of a section of the coupling element shown inFIG. 32B.
• FIG. 33 shows a perspective view of an anchoring element of a bone fixation assembly, in accordance with certain preferred embodiments of the present invention.
• FIG. 34 shows a top plan view of the anchoring element shown inFIG. 33.
• FIGS. 35A and 35B show respective side elevation and cross-sectional views of the anchoring element shown inFIG. 33.
• FIGS. 36A-36C show respective perspective, top plan and cross-sectional views of a locking element threadable into the coupling element ofFIGS. 29-32B-1, in accordance with certain preferred embodiments of the present invention.
• FIG. 37A shows an exploded view of a bone fixation assembly including a coupling element, a fastening element and a locking element, in accordance with certain preferred embodiments of the present invention.
• FIGS. 37B and 38 show respective side elevation and front elevation views of the bone fixation assembly ofFIG. 37A after the coupling element, anchoring element and locking element have been assembled together.
• FIG. 39 shows a cross-sectional view of the bone fixation assembly shown inFIG. 37B.
• FIG. 40 shows a fragmentary view of a driver including a lower end having spaced fingers for engaging a head of an anchoring element, in accordance with certain preferred embodiments of the present invention.
• FIG. 41 shows a cross-sectional view of the driver ofFIG. 41 engaging the head of the anchoring element.
• FIG. 42 shows a perspective view of the driver ofFIG. 42 engaging the head of the anchoring element.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• Referring toFIG. 2, the present invention is generally related to providing bi-axial coupling elements that are capable of pivoting over a broader range of angles (e.g. to an angle θ₂of up to about 110°), thereby providing for greater angulation than is possible with the prior art devices shown inFIG. 1.
• FIGS. 3-16 show a bone fixation assembly, in accordance with certain preferred embodiments of the present invention. The bone fixation assembly may be secured to the pedicles of vertebral bodies of a spinal column. Referring toFIGS. 3-7, the fixation assembly includes acoupling element12 preferably made of a biologically inert material, preferably any metal customarily used for surgical devices and particularly those used for bone screws and pins, such as titanium or stainless steel. Other suitable materials for the coupling element include alloys, composite materials, ceramics or carbon fiber materials. Couplingelement12 has anupper end14 and alower end16. Theupper end14 defines afirst plane23 and thelower end16 defines asecond plane25, the first andsecond planes23,25 preferably intersecting one another.
• Thecoupling element12 includes afirst section18 that extends fromupper end14 to anintermediate region20, and asecond section21 that extends fromintermediate region20 tolower end16. Thefirst section18 has a first bore extending therethrough, which is coaxial with a firstlongitudinal axis22. Thesecond section21 has a second bore extending therethrough, which is coaxial with a secondlongitudinal axis24. The first and secondlongitudinal axes22,24 are preferably angled relative to one another. As a result, the first bore extending through thefirst section18 has an orientation that is non-parallel or tilted in relation to the second bore extending through the second section21 (seeFIG. 4).
• Referring toFIG. 4, the angle ∝ formed between the first and secondlongitudinal axes22,24 may comprise any angle greater than 0° up to but not including 90°. The specific angle α may depend upon the particular application for thefixation assembly10. Preferably, the angle α is approximately between 20-30°. In more preferred embodiments, the angle α is approximately 25°±2°. In highly preferred embodiments, the angle α is approximately 24°. Thecoupling elements12 may be provided in a set, with eachcoupling element12 having a slightly different shape and unique angle. During surgery, a surgeon may select a coupling element from the set having an appropriate angle for the particular patient and/or the particular location along a patient's spine.
• Thecoupling element12 may have other shapes, such as a Polyaxial structure having more than two cylinders (e.g., three), with each cylinder transverse to the other cylinders. In other preferred embodiments, the cylinders may have non-circular cross-sectional shapes, such as square, pentagonal, elliptical, etc.
• Referring toFIGS. 5-7,coupling element12 also desirably has a substantially cylindricalouter surface26 that extends fromupper end14 to aconvex surface28 adjacentlower end16. Couplingelement12 also preferably includes one ormore notches30 formed inouter surface26 so thatcoupling element12 may be secured by a tool, such as a persuader instrument. Thenotches30 preferably extend in directions transverse to the firstlongitudinal axis22.
• Referring toFIG. 7,coupling element12 has aninner surface38 surrounding thefirst bore40, which extends fromupper end14 towardlower end16 and is preferably coaxial with firstlongitudinal axis22. Theinner surface38 preferably includesinternal threads44 extending fromupper end14 towardlower end16. Thecoupling element12 has second bore41 that extends fromlower end16 towardupper end14. Thesecond bore41 is coaxial with secondlongitudinal axis24.
• Referring toFIGS. 5-6,coupling element12 has a pair ofrod receiving openings42 that extend fromouter surface26 toinner surface38, eachrod receiving opening42 communicating withfirst bore40. Therod receiving openings42 are adapted to capture and seat an orthopedic stabilizing rod therein. Therod receiving openings42 preferably comprise U-shaped openings having the respective open ends adjacentupper end14 ofcoupling element12 and the respective closed ends remote from the open ends.
• The rod-receiving openings dividecoupling element12 into afirst arm31A on one side of theopenings42 and a second arm31B on an opposite side of the rod-receivingopenings42. The rod-receivingopenings42 preferably includecuts32 formed adjacentouter surface26 ofcoupling element12. Although the present invention is not limited by any particular theory of operation, it is believed that thecuts32 enable two ormore coupling elements12 to be packed closer together than would be possible for coupling elements having the cuts omitted.
• Referring toFIGS. 6 and 7, thecoupling element12 preferably has achamfer45 that extends fromupper end14 toward aninternal cavity46. Thechamfer45 preferably extends between the openingsurface43 of one of therod receiving openings42 to theinner surface38 on thefirst section18. Thechamfer45 facilitates the insertion of an anchoring element into thecoupling element12; notwithstanding the angle offirst bore40 with respect tosecond bore41. In certain preferred embodiments, thechamfer45 is bored out of the material ofcoupling element12 to essentially form a third axis that is coaxial withsecond bore41 andsecond axis24. Thechamfer43 preferably provides room for an anchoring element and driver to pass therethrough when securing the anchoring element in bone. In other preferred embodiments, the dimensions of the coupling element and anchoring element may be selected to allow the anchoring element to be inserted into the coupling element, without requiring a chamfer.
• Referring toFIG. 7,coupling element12 includes aseat50 adjacentlower end16 for engaging an anchoring element. Theseat50 preferably has a conical shape withsidewalls52 tapering inwardly towardlower end16. In other preferred embodiments, theseat50 is substantially spherical or concave in shape.
• Referring toFIGS. 8-9, the fixation assembly preferably includes an anchoringelement52, such as a screw fastener, having atip end54 for insertion into bone, ahead56 at an upper end thereof, andexternal screw threads58 that extend betweentip end54 andhead56. Thescrew threads58 have aninner diameter64 and anouter diameter66. Thescrew threads58 desirably terminate at aneck60 preferably located betweenhead56 andscrew threads58. The neck has aneck diameter68 that is less than theouter diameter66 of the screw threads. The reduceddiameter neck60 allows thecoupling element12 to pivot and rotate through a broader range of motion relative to anchoringelement52. The anchoringelement52, including thescrew threads58,neck60 andhead56, are preferably made of a biologically inert material, such as titanium or stainless steel.
• Head56 desirably includes one or more depressions orgrooves70 adapted to cooperate with a driver used to screw the anchoringelement52 into bone.Head56 is preferably sized and shaped to pass through the first and second bores formed incoupling element12 until an underside of head engages the seat50 (FIG. 7) of the coupling element. Thehead56 has anunderside57 that is preferably convex or spherical in shape for engaging theseat50. When theunderside57 ofhead56 engages the seat, thetip end54 and threadedportion58 of the anchoringelement52 extend through the second bore41 (FIG. 7) at thelower end16 ofcoupling element12.
• Referring toFIGS. 10-12, in one preferred method for assembling anchoringelement52 withcoupling element12, thetip end54 of anchoringelement52 is passed throughfirst bore40 towardlower end16 so thatscrew threads58 project from thelower end16 of coupling element. In certain preferred embodiments, the anchoringelement52 may pass freely throughfirst bore40 because the outer diameter of thescrew threads58 may be less than the diameter offirst bore40. In other preferred embodiments, the diameter of thethreads58 is substantially similar to the diameter offirst bore40, requiring the anchoring element to be threaded into the coupling element until theunderside57 ofhead56 engagesseat50. In certain preferred embodiments, theunderside57 ofhead56 is spherical and the seat is conical-shaped. In other embodiments, theunderside57 ofhead56 andseat50 comprise other shapes, such as a convex underside and a concave seat.
• Referring toFIGS. 13 and 14, after anchoringelement52 has been assembled withcoupling element12, anchoringelement52 andcoupling element12 are free to pivot and rotate relative to one another. Theneck60 of anchoringelement52 preferably has a reduced diameter with a concaveouter surface62 so that anchoringelement52 andcoupling element12 may pivot over a broader range of angles relative to one another, as compared to an anchoring element on which a reduced diameter neck is omitted.FIG. 13shows coupling element12 in a first position with respect to anchoringelement52.FIG. 14shows coupling element12 in a second position with respect to anchoringelement52 after coupling element has been rotated counterclockwise relative to the position shown inFIG. 13.
• After anchoringelement52 andcoupling element12 have been assembled together, the subassembly is ready to be inserted intobone80. In one preferred embodiment, a pilot hole is drilled in bone, and anchoringelement52 is placed in the pilot hole and screwed into thebone80 using a driver or tool. As anchoringelement52 is rotated by driver, the anchoring element advances longitudinally into thebone80. The anchoringelement52 is preferably advanced into thebone80 until it is firmly secured in place such as when theneck60 of anchoring element is adjacent thebone80. In other preferred embodiments, the tip end includes a cutting edge formed therein such as a cutting flute, so that pre-forming a pilot hole is not required.
• After anchoringelement52 is anchored inbone80,coupling element12 remains free to pivot and rotate relative to anchoringelement52 so that an orthopedic stabilizingrod82 may be captured within therod receiving openings42 ofcoupling element12. In certain preferred embodiments, after the anchoring element has been fully inserted into bone, a gap may exist between thelower end16 ofcoupling element12 andbone80. The gap preferably facilitates pivotal and rotational movement ofcoupling element12 relative to anchoringelement52. In other preferred embodiments, thelower end16 ofcoupling element12 may engage bone during a stabilizing procedure when therod82 is captured by couplingelement12. In these embodiments, however, it is not critical that thelower end16 of thecoupling element12 contact bone in order to form a reliable assembly. In other preferred embodiments, it may be necessary for thelower end16 ofcoupling element12 to engage bone to provide a reliable, stable assembly. Thecoupling element12 may be moved (e.g. pivoted) by grasping the coupling element with a tool.
• Referring toFIG. 15, afterrod82 has been positioned withincoupling element12, a lockingelement84 such as a set screw having external threads, is threaded intointernal threads44 ofcoupling element12 until anunderside85 of lockingelement84 abuts againstrod82. Lockingelement84 is then further tightened for forcingrod82 against the closed ends of therod receiving openings42. The tightenedlocking element84 applies a downward force throughrod82 onto thetop side59 ofhead56. In other embodiments, thecoupling element12 has threads on itsouter surface26 and the locking element comprises an internally threaded sleeve.
• Referring toFIGS. 15-16, the downward force applied byrod82 to thetop side59 ofhead56 forces theunderside57 ofhead56 into theseat50 ofcoupling element12. In embodiments in which theseat50 has a conical shape and theunderside57 has a spherical shape, engagement of theunderside57 with theseat50 creates a spherical/conical surface friction lock that locks the position of thecoupling element12 relative to thehead56, thereby preventing further pivotal and rotary movement of thecoupling element12 and anchoringelement52 relative to one another. Although the present invention is not limited by any particular theory of operation, it is believed that the engagement of the spherical underside of the head with the conical seat of the coupling element is a dramatic improvement over a convex/concave interface and dramatically improves the locking force exerted at the interface of the screwhead and the coupling element. In other embodiments, bothseat50 andunderside57 ofhead56 have spherical shapes.
• In the prior art, it has been observed that some patients have relatively small vertebrae, making it difficult to secure two or more bone fixation assemblies next to each other over adjacent vertebrae. As a result, in some patients, one or more vertebrae may not have a section of a stabilizing assembly attached thereto. This situation may adversely affect stabilization and fusion of a spine segment because the entire portion of the spine segment is not being stabilized. Although the present invention is not limited by any particular theory of operation, it is believed that providingcuts32 adjacent therod receiving openings42 reduces the profile or width of thecoupling element12, thereby minimizing interference with neighboring coupling elements when a series of coupling elements are connected with a spine rod. Thecuts32 allow the coupling elements to be packed tightly together, thereby improving fusion of a spinal segment. Providingcuts32 oncoupling element12 also minimizes the occurrence of sharp edges that may irritate a patient's tissue or cut through the surgical gloves of medical personnel.
• In certain preferred embodiments, the head of the anchoring element preferably has an underside defining a first radial surface and a top side defining a second radial surface, as disclosed in certain embodiments of U.S. patent application Ser. No. 09/755,846, the disclosure of which is hereby incorporated by reference herein. The second radial surface has a radius that is smaller than the radius of the first radial surface, which is believed to provide a lower overall silhouette for the assembly.
• Referring toFIGS. 18-22, in other preferred embodiments,coupling element122 includes a first bore140 extending through afirst section118 coaxial with a firstlongitudinal axis122 and a second bore141 extending through a second section121 a secondlongitudinal axis124, the first and second axis defining an angle coaxial with β that may comprise any angle greater than 0° up to but not including 90°. Preferably, an angle of between 20-30° is used. In more preferred embodiments, the angle β is preferably about 25°±2°. In highly preferred embodiments, the angle β is preferably 24°.
• The present invention also preferably includes a driver, such as that disclosed in certain embodiments of U.S. patent application Ser. No. 09/755,846, filed Jan. 5, 2001, the disclosure of which is hereby incorporated by reference herein. The driver preferably has a rotatable shaft and one or more fingers extending from an end of the shaft for engaging the grooves in the head of the anchoring element. In preferred embodiments, the driver has one finger for each groove in the head of the anchoring element. The driver may also have external threads on a shaft that are adapted for engaging the internal threads of the coupling element when the anchoring element is anchored to bone. The engagement of the external threads of the driver and the internal threads of the coupling element generally stabilizes the assembly when the anchoring element is secured to bone. Specifically, the engagement of the threads prevents the coupling element from moving relative to the anchoring element when driving the anchoring element into bone, thereby facilitating bone anchoring.
• The anchoring element may have expandable head, such as the expandable head disclosed in certain preferred embodiments of commonly assigned U.S. patent application Ser. No. 09/414,272, filed Oct. 7, 1999, the disclosure of which is hereby incorporated by reference herein. The expandable head has a recess and at least one slot extending between inner and outer surfaces of the head, which facilitates expansion of the head. The anchoring element of the '272 patent also has an insert which can be positioned at least partially in the recess, the insert having an outer surface and defining an outer dimension that is greater than the inner dimension of the recess. After a spinal rod has been positioned within a coupling element, a locking element associated with the coupling element locks the orthopedic rod in the rod-receiving opening. The locking element forces the orthopedic rod into the rod receiving opening, to in turn force the insert into the recess of the expandable head. As the insert is forced into the recess, the outer dimension of the insert bears against the inner dimension of the head, thereby expanding the outer surface of the head against a seat of the coupling element for locking the coupling element from further pivotal movement.
• As shown inFIG. 23,pedicle fixation assemblies110A,110B may be mounted adjacent one another so as to engage aspinal rod82. As shown inFIG. 24, theanchoring elements152A,152B may be locked in place with respect to thecoupling elements112A,112B so as to form angles with respect to thespinal rod82, in the xy, xz, or yz planes.
• FIGS. 25-27 show acoupling element212 for a pedicle fixation assembly in accordance with another preferred embodiment of the present invention. Couplingelement212 has anupper end214 and alower end216, theupper end214 defining afirst plane223 and thelower end216 defining asecond plane225, the first andsecond planes223,225 intersecting one another.
• Referring toFIGS. 26-27,coupling element212 has afirst bore240 that extends alongfirst axis222 fromupper end214 to anintermediate region220, and asecond bore241 that extends alongsecond axis224 fromlower end216 ofcoupling element212 tointermediate region220. Thefirst bore240 andsecond bore241 are generally oriented non-parallel or transverse to one another.
• The angle θ betweenfirst axis222 coaxial withfirst bore240 andsecond axis224 coaxial withsecond bore241 may comprise any angle greater than 0° up to but less than 90°. The angle θ may vary depending upon the particular application for thecoupling element212. Preferably, the angle θ is approximately between 20-30°. In more preferred embodiments, the angle θ is approximately 25°±2°. In highly preferred embodiments, the angle θ is approximately 24°.
• Referring toFIG. 25,coupling element212 desirably has anouter surface226 that is cylindrical in shape, extending fromupper end214 tolower end216.Outer surface226 preferably includes one ormore notches230 formed therein so thatcoupling element212 may be grasped and/or maneuvered using a securing element or tool. Thenotches230 preferably extend in directions that intersect firstlongitudinal axis222.
• Referring toFIGS. 25-27, thefirst section218 ofcoupling element212 preferably includesinternal threads244 extending fromupper end214 towardlower end216. Couplingelement212 has a pair ofrod receiving openings242 in communication withfirst bore240 that extend fromouter surface226 toinner surface238 ofcoupling element212. Therod receiving openings242 are adapted to seat a spinal rod (not shown) therein. Therod receiving openings242 preferably comprise U-shaped openings having open ends adjacentupper end214 and closed ends opposite the open ends. The rod-receivingopenings242divide coupling element212 into afirst arm231A and asecond arm231B.
• Thecoupling element212 has acavity246 insecond section221 and aseat250 for engaging an anchoring element. In the particular preferred embodiment shown inFIG. 26,seat250 is a conical-shapedseat including sidewalls252 tapering inwardly toward one another adjacentlower end216. In other preferred embodiments,seat250 may be substantially spherical or concave.
• FIGS. 28A and 28B show a metal blank310 used to make a coupling element, in accordance with other preferred embodiments of the present invention. The metal blank310 preferably has a cylindricalouter surface326, a longitudinal axis designated A-A, and alower end316 that is chamfered. Themetal blank310 is bored fromupper end314 towardlower end316 to formfirst bore340 coaxial with longitudinal axis A-A.
• Referring toFIGS. 29-31,coupling element312 has a rod-receivingopening342 that divides opposingarms331A,331B from one another. Thecoupling element312 has anouter surface326 including a pair of gripping notches30A,30B on eachopposing arm331A,331B. The opposinggripping notches330A,330B may be secured with a tool, such as forceps (not shown).
• Referring toFIGS. 30-31, the opposing pairs ofgripping notches330A,330B are cut into therespective arms331A,331B ofcoupling element312. In certain preferred embodiments, the grippingnotches330A,330B are formed using a rotary cutter, such as a woodruff cutter, that is abutted laterally againstexterior surface326 ofcoupling element312. A first pair ofgripping notches330A onfirst arm331A are separated from one another by afirst rib333A extending therebetween. Similarly, a second pair ofgripping notches330B on second arm331B are separated from one another bysecond rib333B. Couplingelement312 has two bores extending therethrough. Afirst bore340 extends in a direction substantially parallel to the axis designated A-A. Thefirst bore340 is preferably formed by drilling from theupper end314 toward thelower end316 of thecoupling element312. Couplingelement312 also includes asecond bore341 extending from thelower end316 towardupper end314 along axis B-B. In certain preferred embodiments, the first andsecond bores340,341 may not extend completely through the length ofcoupling element312, but may meet at an intermediate region betweenupper end314 andlower end316.
• Referring toFIG. 31,first bore340 is coaxial with axis A-A andsecond bore341 is coaxial with axis B-B. Thefirst bore340 extends fromupper end314 towardlower end316 ofcoupling element312, andsecond bore341 extends fromlower end316 towardupper end314.Upper end314 ofcoupling element312 defines afirst plane423 andlower end316 defines asecond plane425. The first andsecond planes423,425 are preferably angled relative to one another and intersect one another.
• FIG. 32A showscoupling element312 includingsecond bore341 formed fromlower end316 thereof and extending along axis B-B. Referring toFIG. 32B,first bore340 is coaxial with axis A-A andsecond bore341 is coaxial with axis B-B. Couplingelement312 includesinternal threads344 extending fromupper end314 towardlower end316. The exterior surface ofcoupling element312 adjacentlower end316 is preferably chamfered. In certain preferred embodiments, the chamfered surface is formed by rotatingcoupling element312 about axis B-B and engaginglower end316 with a grinding tool. Anintermediate region321 ofcoupling element312 includes a retaininglip343. As will be described in more detail below, retaininglip343 prevents an anchoring element such as a screw fastener from disassembling withcoupling element312 after the coupling element and the anchoring element have been assembled together.Second bore341 formed inlower end316 ofcoupling element312 preferably includes aseat350 havingside walls352 that taper inwardly toward one another. As shown inFIG. 32B-1, theside walls352 and axis B-B preferably define an angle of approximately 8-12° and more preferably about 10°.
• Referring toFIGS. 33-35B, the pedicle screw assembly of the present invention also includes anchoringelement352 having tip end354 andhead356 remote therefrom. In certain preferred embodiments,head356 has a spherical radius.Head356 includes evenly spacedcuts370 formed in the exterior surface ofhead356. In certain preferred embodiments, the spacedcuts370 are made using a grinding or milling tool that engages the head from lateral sides.Fastening element352 includesexternal screw threads358 having anouter diameter366 and an inner diameter364.Fastening element352 also includesneck360 provided between an upper end ofscrew threads358 andhead356. Theneck360 has aconcave surface362.Fastening element352 also includes a cuttingsurface371, such as a cutting flute, formedadjacent tip end354. As is known to those skilled in the art, providing a cuttingflute371 at atip end354 offastening element352 avoids the need to pre-tap into bone, which in turn provides for a tighter, snugger fit between thefastening element352 and bone. As thefastening element352 is screwed into bone, the cuttingflute371 cuts into the bone, thereby avoiding the need to pre-tap the bone. When screwingfastening element352 in bone, the evenly spacedcuts370 onhead356 are engaged by the fingers of a driver, as will be described in more detail below.
• Referring toFIGS. 36A-36C, fixation assembly also preferably includes a locking element such as aset screw390 having anupper end392, alower end394 andexternal threads396 extending between the upper and lower ends. Setscrew390 includes a hexagonal shapedopening398 extending fromupper end392 towardlower end394, which is adapted to receive an end of a hexagonal driver for turning setscrew390. As will be described in more detail below, anunderside394 of setscrew390 is adapted to abut against an orthopedic stabilizing rod for exerting a downward force on a head of an anchoring element for locking fixation assembly from further movement.
• FIG. 37A-39A show a fixation assembly includingcoupling element312,screw fastener352 and setscrew390 prior to the components being assembled together. In one preferred embodiment, thetip end354 ofscrew fastener352 is passed through thefirst bore340 extending fromupper end314 ofcoupling element312. In certain embodiments, theexternal threads358 ofscrew fastener352 must be threaded past internal threads (not shown) ofcoupling element312, however, in other preferred embodiments, the threaded portion may pass the internal threads by rocking the threadedportion358 back and forth until the threadedportion358 ofscrew fastener352 clears a lower end of the internal threads. After thethreads358 ofscrew fastener352 have cleared the interval threads ofcoupling element312, thehead356 ofscrew fastener352 is press fit intoseat350 adjacentlower end316 ofcoupling element312. Thehead356 ofscrew fastener352 preferably has a diameter that is slightly greater than the diameter of the bore at retaininglip343. Ashead356 is pushed through retaininglip343, the retaininglip343 is slightly deformed to allow the head to pass intoseat350. Oncehead356passes retaining lip343, the retaininglip343 springs back to a diameter that is smaller than the outer diameter ofhead356. As a result,head356 is captured inseat350 ofcoupling element312 between retaininglip343 and the opening at thelower end316 ofcoupling element312. Once thehead356 is captured withinseat350, thescrew fastener352 andcoupling element312 are able to pivot and rotate relative to one another.
• Referring toFIGS. 40-42, after thehead356 of anchoringelement352 has been captured within theseat350 ofcoupling element312, the bone fixation assembly is ready to be anchored into bone and coupled with an orthopedic stabilizing rod. In one preferred embodiment, adriver421 includingshaft423 havinglower end425 with spacedfingers427 projecting therefrom is placed in substantial alignment overhead356 ofscrew fastener352. Thefingers427 are preferably substantially rigid so as to limit flexing or bending of thefingers427 as forces are exerted upon the fingers. Thefingers427 are then seated in spacedcuts330 ofhead356.Driver421 also includes ashaft423 having external threads429 adapted to mesh with theinternal threads344 ofcoupling element312 for stabilizingcoupling element312 andscrew fastener352 asscrew fastener352 is threaded into bone.Driver421 also preferably includes asleeve425 slidable alongshaft423 for sliding overexterior surface326 ofcoupling element312 to further stabilize the fixation assembly when threadingfastening element352 into bone.
• Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the embodiments disclosed herein and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims (21)

1. (canceled)

2. A bone fixation assembly, comprising:

a coupling element having an upper end, a lower end and an inner surface defining first and second bores, the first bore being coaxial with a first axis and the second bore being coaxial with a second axis different than the first axis; and

a monolithic anchoring element having a head and a shaft, a portion of the head being disposed within the second bore of the coupling element and a portion of the shaft projecting from the lower end of the coupling element.

3. The assembly ofclaim 2, wherein the inner surface forms a seat for the head of the anchoring element.

4. The assembly ofclaim 3, wherein the seat is substantially conical, tapers toward the second axis and prevents the head of the anchoring element from passing through the lower end of the coupling element.

5. The assembly ofclaim 2, wherein the first bore extends from the upper end toward the lower end and the second bore extends from the lower end toward the upper end.

6. The assembly ofclaim 2, wherein the first and second bores are in communication with one another between the upper and lower ends of the coupling element.

7. The assembly ofclaim 2, wherein the head of the anchoring element has a substantially spherical surface.

8. The assembly ofclaim 7, wherein the anchoring element includes a neck at the junction of the head and the shaft, the neck having a diameter less than a greatest diameter of the shaft for facilitating pivotal movement of the anchoring element relative to the coupling element.

9. The assembly ofclaim 2, further comprising a locking element engagable with the coupling element for locking an angular position of the anchoring element relative to the coupling element.

10. The assembly ofclaim 2, wherein the inner surface is chamfered and facilitates insertion of the anchoring element through the first bore and into the second bore.

11. The assembly ofclaim 2, wherein the coupling element further defines a U-shaped channel.

12. The assembly ofclaim 2, further comprising a stabilizing rod positioned within the U-shaped channel.

13. The assembly ofclaim 12, further comprising a locking element engagable with the coupling element to secure the stabilizing rod within the coupling element.

14. The assembly of13, wherein the locking element is a set screw and is threadably engaged to threading on the inner surface of the coupling element.

15. A bone fixation assembly, comprising:

a coupling element having an upper end, a lower end and an inner surface defining a first bore and a second bore, the first bore extending along a first axis and the second bore extending along a second axis, the first and second axes forming an angle of greater than 0 degrees and less than 90 degrees with respect to each other; and

an anchoring element having a head and a shaft, a portion of the head being disposed within the second bore of the coupling element and a portion of the shaft projecting from the lower end of the coupling element.

16. The assembly ofclaim 15, wherein the angle between the first and second axes is between approximately 20 degrees and approximately 30 degrees.

17. The assembly ofclaim 15, wherein the angle between the first and second axes is between approximately 23 degrees and approximately 27 degrees.

18. The assembly ofclaim 15, wherein the angle between the first and second axes is approximately 24 degrees.

19. The assembly ofclaim 15, wherein the inner surface of the second bore defines a conically shaped seat adapted to prevent the head of the anchoring element from passing through the lower end of the coupling element.

20. The assembly ofclaim 19, wherein a portion of the head of the anchoring element is substantially spherical in shape and adapted to engage the conical seat of the coupling element to allow the anchoring element to rotate about the second longitudinal axis.

21. The assembly ofclaim 15, wherein the head of the screw has a depression adapted to receive a driver for driving the shaft of the anchoring element into bone.

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