1. Field of the Invention
The present invention relates generally to bone fixation systems and methods of assembly, operation, and/or installation of these systems into cancellous and/or cortical bone.
2. Description of the Related Art
Various bone fixation systems for internally fixing, fusing, and/or otherwise supporting portions of a skeletal system for a human or other-type animal are known in the art. Bone fixation systems used along the spinal region of a patient are commonly referred to as a pedicle screw construct or a pedicle screw-coupling device because the pedicle screws are typically inserted and secured into the pedicles. Pedicles are generally understood to refer to the bone that bridges an anterior vertebral body to a lamina. U.S. Pat. No. 5,669,911 provides a detailed and thorough description of a spinal system including a discussion about the various bones and connective tissue associated therewith.
Pedicle screw constructs typically include a pedicle screw and a rod-coupling mechanism that are pre-operatively assembled. Some examples of pre-operatively assembled pedicle screw constructs are described in U.S. Published Patent Application Nos. 2005/0187548, 2005/0192571, and 2005/0216003. One drawback of pre-operatively assembled pedicle constructs is that the insertion of these constructs through the skin, muscle, and/or other tissue during surgery may cause damage and/or trauma to the tissue because the construct is larger and bulkier than the pedicle screw alone. In addition, the pre-operatively assembled pedicle constructs may be difficult to handle, maneuver, and to ultimately secure to the bone because the surgeon must direct the tool that drives the pedicle screw into the bone down through the rod-coupling mechanism to engage a driving portion of the pedicle screw. Further, the rod-coupling mechanism may be free to rotate relative to the pedicle screw, making it more difficult for the surgeon to guide and engage the tool with the pedicle screw.
The invention is related to systems and methods for achieving internal fixation of vertebral bodies.
In one aspect, a tulip assembly is coupleable to a pedicle screw having a head portion and a threaded shaft. The head portion is coupled to the threaded shaft. The tulip assembly includes a tulip body having an intermediate web, an upper portion positioned above the intermediate web, and a lower portion positioned below the intermediate web. The upper and lower portions are displaceable in substantially a radial direction relative to the intermediate web. The lower portion is radially expandable by an amount to intra-operatively receive the head portion of the pedicle screw, which may occur after the pedicle screw is secured into bone. A cap is engageable with the upper portion of the tulip body to lock the lower portion of the tulip body onto the head portion of the pedicle screw when the tulip body is at a desired angle relative to the pedicle screw.
In another aspect, a pedicle screw system includes a pedicle screw and a tulip assembly. The pedicle screw includes a head portion and a threaded shaft, where the head portion is coupled to the threaded shaft. The tulip assembly includes a tulip body and a cap. The tulip body has an intermediate web, an upper portion positioned above the intermediate web, and a lower portion positioned below the intermediate web. The upper and lower portions are displaceable in substantially a radial direction relative to the intermediate web. The lower portion is radially expandable by an amount to intra-operatively receive the head portion of the pedicle screw after the pedicle screw is secured into bone. The cap is engageable with the upper portion of the tulip body to lock the lower portion of the tulip body onto the head portion of the pedicle screw when the tulip body is at a desired angle relative to the pedicle screw and before the rod is locked into the tulip assembly.
In yet another aspect, a method is provided for installing a pedicle screw system into bone. The pedicle screw system includes a pedicle screw and a tulip assembly. The method begins by inserting the pedicle screw into the bone. Next, but not necessarily in the following sequence, the method includes coupling the tulip assembly to a head portion of the pedicle screw by radially, outwardly displacing a lower portion of a tulip body by an amount sufficient to receive the head portion of the pedicle screw. At least a section of a rod is placed onto a rod-support member that is positioned within the tulip body. The tulip assembly is fixed to the head portion of the pedicle screw by rotationally engaging a cap with the upper portion of the tulip body, the cap configured to cam the upper portion of the tulip body radially outward when rotated, and in turn, cause the lower portion of the tulip body to clamp onto the head portion of the pedicle screw. A fastening member is inserted into the tulip assembly to provide a downward force on at least a portion of the section of the rod to fixedly retain the same in the tulip assembly.
The foregoing is a summary and thus contains, by necessity, simplifications, generalizations, and omissions of detail; consequently, those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the non-limiting detailed description set forth herein.
In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings.
In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the present tools, assemblies, systems, and methods. However, one skilled in the relevant art will recognize that the assemblies, systems, and methods may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with bone fixation systems and the assembly and/or installation thereof have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments of the present assemblies, systems, and methods.
Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as “comprises” and “comprising,” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.”Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present assemblies, devices, and systems. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention.
Pedicle Screw System
In one embodiment, the pedicle screw 102 is cannulated, wherein a channel 114 extends through the entire length of the pedicle screw 102. The channel 114 allows the pedicle screw 102 to be maneuvered over and receive a Kirschner wire, commonly referred to as a K-wire. The K-wire is typically pre-positioned using imaging techniques, for example, fluoroscopy imaging.
For example and as will be further described in the assembly methods below, the tulip body 120 is placed over the head portion 110 of the pedicle screw 102 by radially compressing (e.g., squeezing) the upper portion 130 of the tulip body 120 so that the spherical bore 134 opens by an amount sufficient to receive the head portion 110 of the pedicle screw 102. In one embodiment, the tulip body 120 is placed over the head portion 110 of the pedicle screw 102 intra-operatively (i.e., during surgery). Likewise, the lower portion 128, in particular a region 142 beneath the web 132, is compressible during pre-operative assembly of the tulip assembly 106. During pre-operative assembly, the region 142 is squeezed to cause the upper portion 130 to splay apart (i.e., open wider and/or expand) to allow the rod-support member 124 to be inserted into an opening 144 of the tulip body 120. In addition, squeezing the region 142 permits the collar member 122 to be moved over the radial flange 138 and encircle at least part of the lower portion 128 of the tulip body 120. It is understood that squeezing the region 142 may be achieved by applying an inward radial force on at least a portion of the first outer perimeter 140 that corresponds to the region 142. Additionally or alternatively, squeezing the region 142 may be achieved by applying an outward radial force to an inner surface 146 of the upper portion 130 of the tulip body 120 or by installing the cap 126 as will be described in more detail below.
The upper portion 130 includes a second outer perimeter 148 and a cap-mating groove 150. The second outer perimeter 148 is larger than the first outer perimeter 140 of the lower portion 128. The cap-mating groove 150 includes a lip 152. The cap-mating groove 150 is sized to receive the cap 126, wherein the lip 152 is arranged to retain the cap 126 as will be described in more detail below.
The outer surface 162 is sized to fit through the opening 144 of the tulip body 120 and be placed in the counterbored region 136 of the tulip body 120 when the rod-support member 124 is pre-operatively assembled with the tulip body 120. The upper surface 164 engages a portion of the counterbored region 136 to retain the rod-support member 124 in the counterbored region 136 of the tulip body 120. The opening 166 of the rod-support member 124 permits access to the driving feature 112 of the pedicle screw 102. Accordingly, the opening 166 permits the adjustment of the pedicle screw 102 after the tulip assembly 106 has been coupled to the pedicle screw 102.
In one embodiment, an effective cam length 180 of the cap 126 is slightly larger than an internal, diametrical distance 182 (
Operation/Assembly
The assembly method 200 begins at step 202 where the collar member 122 and the rod-support member 124 are pre-operatively assembled with the tulip body 120 as described above. It is understood that this pre-operative assembly may take place generally within the hospital or surgical center, possibly even in or near the operating room, or alternatively may take place at a manufacturer before the respective parts are shipped.
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Advantages
One possible advantage of the pedicle screw system 100 is that the dual diameter head portion 110 of the pedicle screw 102 allows the rod-support member 124 to sit low in the tulip assembly 106, which reduces the overall height of the tulip assembly 106 or, alternatively stated, reduces how much the tulip assembly 106 extends above the head portion 110 of the pedicle screw. This reduced height may mitigate soft tissue irritation, especially post-operatively.
Yet another possible advantage is that the dual diameter head portion 110 permits the various components of the tulip assembly 106 to remain concentric, which may permit easier movement (e.g., less frictional binding and/or resistance) between the tulip assembly 106 and the head portion 110 of the pedicle screw 102.
Yet another possible advantage is that the cap 126 may be easily rotated in the tulip body 120 to cause the radial, outward expansion of the upper portion 130 of the tulip body 120. The radial, outward expansion provisionally locks the tulip body 106 to the pedicle screw 102 by causing the lower portion 128, in particular the spherical bore 134, to clamp onto the head portion 110 of the pedicle screw 102. Thus, the angular position of the tulip body 106 relative to the pedicle screw 102 may be quickly locked, then unlocked, and then re-locked at a different angular orientation by merely rotating the cap 126. This flexibility allows the surgeon to repetitively and intra-operatively adjust, if necessary, the angular orientation of the tulip assembly 106 relative to the pedicle screw 102 without causing extra stress to the pedicle screw 102 and/or the bone 302.
Yet another possible advantage is that the protuberances 176 of the cap 126 radially restrain the upper portion 130 of the tulip body 120, thus reducing or possibly eliminating any post-operative splaying and/or undesired flexing of the upper portion 130 of the tulip body 120. Accordingly, the post-operative life of the pedicle screw system 100 may be longer when compared to other, conventional pedicle screw constructs, which in turn may reduce or eliminate any follow-up, repair, and/or maintenance-type spinal operation, for example to fix or replace a broken pedicle screw construct.
All of the above U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications referred to in this specification and/or listed in the Application Data Sheet, including but not limited to U.S. Provisional Patent Application No. 60/622,107 filed Oct. 25, 2004, are incorporated herein by reference, in their entirety.
From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60/622,107 filed Oct. 25, 2004, where this provisional application is incorporated herein by reference in its entirety.
Number | Date | Country | |
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60622107 | Oct 2004 | US |