Patent Application
20120203281
The present disclosure generally relates to the field of spinal orthopedics, and more particularly to a semi-rigid screw assembly that attaches to a vertebra.
The spine is a flexible column formed of a plurality of bones called vertebrae. The vertebrae are hollow and stacked one upon the other, forming a strong hollow column for support of the cranium and trunk. The hollow core of the spine houses and protects the nerves of the spinal cord. The different vertebrae are connected to one another by means of articular processes and intervertebral, fibrocartilaginous bodies. Various spinal disorders may cause the spine to become misaligned, curved, and/or twisted. It is often necessary to surgically correct and stabilize spinal curvatures or to facilitate bone fusion between two or more adjacent vertebrae.
One procedure for treating spinal disorders involves attaching a rigid fixation system of bone screws and rods to the posterior side of the vertebrae to position the vertebrae for bone fusion. A patient may be positioned to permit surgical access to the spinal area. Once the spine is exposed, the vertebrae may be instrumented with a series of screw assemblies that are driven into each of the vertebrae for attachment of fixation rods. The screw assemblies may include mono-axial or poly-axial screws that are driven into the pedicles of the vertebrae. The screw assemblies also include rod receiving heads that couple with the screws. The heads typically include threaded channels for receiving the fixation rods.
The fixation rods may be shaped to a predetermined alignment and curvature depending on the anatomy of the patient. The fixation rods are inserted into the threaded channels of the heads. Locking set screws are inserted into the threaded channels and tightened to secure the fixation rods and screws together within the heads. Prior to or after fixation of the vertebrae, a spinal spacer, bone graft, and/or bone material may be inserted between two or more instrumented vertebrae to fuse the bones together. Thus, the screw assemblies and fixation rods hold the vertebrae in position to improve fusion of the vertebrae during patent recovery periods.
Typically, spinal fixation systems, including fixation rods and screw assemblies, are designed to be substantially rigid and allow little or no movement of the instrumented, fixed vertebrae. Thus, inter-vertebral movement between any of the fixed vertebrae is substantially limited. As a patient begins to move during recovery, stresses and forces that would normally act on the fixed vertebrae may be transferred by the rigid fixation system to adjacent, non-instrumented vertebrae. This type of rigid fixation system may be preferred for a variety of reasons. For example, rigid fixation may be preferred to alleviate stress on nearby nerves, tissue, and/or a damaged vertebra. Rigid fixation may be preferred to prevent disruption of the fusion process between fixed vertebrae due to movement of an implant, bone graft, or bone cement when the patient begins to move during recovery.
In addition to these benefits, this type of rigid fixation may also negatively impact patient recovery in a number of ways. For example, according to the principle of Wolff's law, bone growth may be accelerated when stress is applied to targeted areas of the healing bones. Therefore, vertebrae that are deprived of stress may be less apt to successfully fuse with adjacent bone segments as desired. Also, non-instrumented vertebrae above and below the instrumented vertebrae must absorb the loads that would ordinarily be shared by the instrumented vertebrae. These non-instrumented vertebrae also must provide a greater range of motion to compensate for the lost range of motion of the instrumented vertebrae. Last, in a typical rigid construct, the weakest point in the fixation system is located at the vertebra/screw intersection. This may result in screw loosening since bone material inside the vertebra, which is a low rigidity material, absorbs most of the stresses.
A semi-rigid head for a bone screw comprising includes a first rigid portion, a second rigid portion, and a semi-rigid portion. The first rigid portion is configured to receive a fixation rod. The second rigid portion is configured for coupling with a bone screw. The semi-rigid portion links the first rigid portion and the second rigid portion.
In other features, the semi-rigid portion includes flexible members that link the first rigid portion and the second rigid portion. The semi-rigid portion controls movement of the first rigid portion relative to the second rigid portion in a direction substantially parallel to the fixation rod. The semi-rigid portion permits a predetermined amount of movement of the first rigid portion relative to the second rigid portion. The first rigid portion includes a top portion, the second rigid portion includes a bottom portion opposite the top portion, and the semi-rigid portion includes four flexible members linking the top portion and the bottom portion. The semi-rigid portion includes joints comprising at least one of pivoting hinges, springs, bushings, varying material properties, and living hinges. The first rigid portion includes a saddle that extends distally inside a cavity of the semi-rigid head. The second rigid portion includes a collet that extends distally for coupling with a driving end of the bone screw.
In yet other features, a locking member with a bottom portion having an aperture slides over the collet to rigidly couple the semi-rigid head to the driving end. The locking member includes side portions extending proximally from the bottom portion to engage with a set screw.
A polyaxial screw assembly includes a bone screw, a semi-rigid head, a locking member, and a set screw. The bone screw includes a threaded end for attachment to a vertebra and a driving end. The semi-rigid head includes a first rigid portion that receives a fixation rod, a second rigid portion that couples to the driving end, and a semi-rigid portion linking the first and second rigid portions. The locking member includes a locked position and an unlocked position. The set screw selectively engages the fixation rod to lock the fixation rod within the first rigid portion and selectively positions the locking member to lock the second rigid portion to the driving end in the locked position. The semi-rigid portion allows a predetermined amount of movement of the fixation rod relative to the vertebra when the locking member is in the locked position.
In other features, the semi-rigid head rotates freely about the driving end when the locking member is in the unlocked position. The set screw includes a first portion that engages the fixation rod and a second portion that engages the locking member. The first rigid portion includes a saddle that receives the fixation rod. The second rigid portion includes a collet that couples to the driving end. The locking member includes an aperture that compresses the collet in the locked position.
A method of securing a fixation rod to a bone screw with a polyaxial head includes the step of inserting the fixation rod within a first rigid portion of the head. The method includes coupling a second rigid portion of the head to a driving end of the bone screw, wherein the first and second rigid portions are linked by a semi-rigid portion. The method includes coupling a locking member to the second rigid portion, the locking member positionable between a locked position that locks the second rigid portion to the driving end and an unlocked position that permits polyaxial movement of the head relative to the driving end. The method includes inserting a set screw within the first rigid portion to selectively lock the fixation rod within the first rigid portion and to selectively position the locking member between the locked position and the unlocked position.
In other features, coupling the locking member to the first rigid portion includes inserting a collet of first rigid portion through an aperture of the locking member. The method includes advancing the set screw until a first end engages the fixation rod and locks the fixation rod to the first rigid portion. The method includes continuing to advance the set screw until a second end engages the locking member to position the aperture and compress the collet to lock the first rigid portion to the driving end.
A semi-rigid screw assembly according to the principles of the present disclosure improves patient recovery in a number of ways. The semi-rigid screw assembly allows a predetermined amount of controlled movement between instrumented vertebrae to promote bone fusion according to Wolff's law. The screw assembly also evenly distributes loads among the instrumented vertebrae and provides improved range of motion of the instrumented vertebrae. The stress distribution within the instrumented segment of the vertebrae is better distributed among several areas of the fixation system. By creating a flexible or semi-rigid region in the screw, stresses may be dissipated among multiple screws and vertebrae, thus decreasing the stress on the bone marrow and preserving structure that supports the bone screws.
The semi-rigid screw assembly of the present disclosure provides a semi-rigid attachment of a rigid fixation rod to the screw assembly. The semi-rigid screw assembly allows a calibrated amount of controlled movement of the fixation rod relative to the screw assembly. Thus, when two or more vertebrae are instrumented, some movement between the instrumented vertebrae may occur. The semi-rigid screw assembly may include a number of configurations including a poly-axial configuration and a mono-axial configuration.
In a poly-axial configuration, the semi-rigid screw assembly includes a bone screw that attaches to the vertebra and a semi-rigid head that couples with the driving end of the bone screw. In a mono-axial configuration, the semi-rigid head may be integral with the bone screw. The semi-rigid head includes a first rigid portion that couples with the bone screw and a second rigid portion for attachment of the fixation rod. A semi-rigid portion between the first and second rigid portions allows the second rigid portion to move relative to the first rigid portion. When the fixation rod is attached to the second portion, the fixation rod may move relative to the first portion. Thus, the semi-rigid head allows a calibrated amount of controlled movement between two or more instrumented vertebrae to improve bone fusion and reduce stress on adjacent non-instrumented vertebrae.
Embodiments of the invention will now be described with reference to the Figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the invention described herein. The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of an instrument nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant.
Referring now to
The semi-rigid head 106 may include rigid portions and semi-rigid portions that allow a predetermined amount of controlled movement of the fixation rod 200. The amount of movement allowed may be based on factors that include preventing disruption of bone fusion while also encouraging bone fusion according to Wolff's Law. The screw assemblies 100 may allow movement in one or more directions. For example, with respect to
Referring now to
Continuing now with
The distal end of the semi-rigid head 106 includes a bottom portion 136 that couples with the bone screw 102. In the poly-axial configuration of FIGS. 3 and 5-8, the bottom portion 136 may include the expandable collet 122 for attachment to the driving end 112 of the bone screw 102. The collet 122 and the locking member 104 may be used to rigidly couple the semi-rigid head 106 to the driving end 112 of the bone screw 102. The collet 122 may include a number of kerf cuts 124 that enable elastic and/or plastic expansion and contraction of the collet 122. For example, the collet 122 may contract when inserted through the aperture 120 of the locking member 104 and expand after passing therethrough. The collet 122 may contract around the driving end 112 of the bone screw 102 when the locking member 104 is actuated as described with reference to
The semi-rigid head 106 further includes semi-rigid portions 138 disposed between the top portion 126 and the bottom portion 136 to enable a predetermined amount of controlled movement of the fixation rod 200 relative to the screw assemblies 100. The semi-rigid portions 138 may be elastically flexible. For example, the semi-rigid portions 138 may include four legs 138 that connect the top portion 126 and the bottom portion 136 to substantially form a cuboidal geometry. The legs 138 may include joints 139 where connected to the top portion 126 and bottom portion 136. Each leg 138 includes a width W and a thickness T that determine the rigidity of the leg 138 and thus, the amount of movement each leg 138 may allow based on a predetermined level of force F. For example, in
In other examples, each leg 138 may include a varying width W and thickness T that determine a varying amount of rigidity along the length of each leg 138. For example, where the legs 138 join the top portion 126 and the bottom portion 136, the thickness T may be less than the thickness T near the center of the legs 138. In other examples, the legs 138 and joints 139 may include additional features, such as pivoting hinges, springs, bushings, varying material properties, living hinges, and the like, that allow a predetermined amount of controlled movement of the top portion 126 relative to the bottom portion 136. In still other examples, the amount of controlled movement permitted may be adjusted by varying a distance D between the legs 138 and the saddle 128. For example, the greater the distance D is, the greater the amount of permitted movement before the saddle 128 begins to contact one of the legs 138. The smaller the distance D is, the lesser the amount of permitted movement before the saddle 128 begins to contact one of the legs 138.
By varying any of the dimensions W, T, and D of the semi-rigid portions 138 of the semi-rigid head 106, the rigidity and amount of predetermined movement may be adjusted to conform to any particular surgical and recovery requirements. Thus, the semi-rigid head 106 may be configured for a variety of patient characteristics and surgical locations. For example, different areas of the spine support different amounts of weight based on the location along the spinal column and/or the anatomy of the patient. When lower weights are supported, the semi-rigid portions 138 may include dimensions that require less force F to move than when higher weights are supported. For example, in the cervical region of the spine, less weight is supported by those vertebrae than by vertebrae in the thoracic region of the spine. Thus, the dimensions of the semi-rigid head 106 may be smaller for cervical applications than for thoracic applications.
Although the terms rigid and semi-rigid are used throughout the present disclosure, one skilled in the art may understand that rigidity may also be describe in terms of an amount of flexibility. Thus, for example, by varying the dimensions of the semi-rigid portions 138 of the semi-rigid head 106, the flexibility may be adjusted. The more flexible the semi-rigid portions 138 are, the less force required to deform the semi-rigid head 106. The less flexible the semi-rigid portions 138 are, the more force that is required to deform the semi-rigid head 106.
Referring now to
Although the semi-rigid head 106 of the present example provides flexibility in one direction, multiple directions of movement may be allowed for various applications. By varying the dimensions of the semi-rigid portions 138 of the semi-rigid head 106, the direction of the controlled movement may also be adjusted to conform to any particular surgical and recovery requirements. Thus, the semi-rigid head 106 may be configured for a variety of patient characteristics and surgical locations. For example, different areas of the spine may require movement in one or more directions corresponding to the X, Y, and Z axes. In lower regions of the spine, such as the lumbar region, less twisting of the spine may occur than in higher regions of the spine such as the thoracic region. Thus, the semi-rigid head 106 may be configured to allow for movement in two directions in the thoracic region and one direction in the lumbar region.
Referring now to
As the flanged screw 108 is tightened, more of the threads 142 engage the threads 134 of the semi-rigid head 106. A distal end 148 of the flanged screw 108 compresses the fixation rod 200 against the saddle 128. Simultaneously, the outer edge 144 of the flanged screw 108 may push down on the projections 146, forcing the bottom portion 116 of the locking member 104 away from the bottom portion 136 of the semi-rigid head 106. As the aperture 120 (not shown) in the bottom portion 116 passes over the collet 122, the collet 122 contracts around the driving end 112 of the bone screw 102. As the flanged screw 108 is fully tightened, the distal end 148 rigidly couples the fixation rod 200 within the saddle 128 and the locking member 104 rigidly couples the collet 122 with the driving end 112 of the bone screw 102.
Although a single flanged screw 108 is illustrated in the current example screw assembly 100, multiple screws may be used to compress the fixation rod 200 against the saddle and force the bottom portion 116 of the locking member 104 to compress the collet 122 around the driving end 112. For example a pair of concentric screws may be used. The flanged screw 108 may include a concentric set screw (not shown) that may be tightened downwardly to compresses the fixation rod 200 against the saddle 128. The flanged screw 108 may be tightened separately from this set screw to rigidly lock the semi-rigid head 106 with the driving end 112.
Example embodiments of the methods and systems of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only, and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.
This application claims priority to U.S. Provisional Application Ser. No. 61/439,858 filed Feb. 5, 2011 and incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61439858 | Feb 2011 | US |
