1. Field of the Invention
The invention relates to the field of implantable fusion cages for use in the spinal column.
2. Description of the Prior Art
Fusion cages provide a space for inserting a bone graft between adjacent portions of bone. In time, the bone and bone graft grow together through or around the fusion cage to fuse the graft and the bone solidly together. One current use of fusion cages is to treat a variety of spinal disorders, including degenerative disc diseases, Grade I or II spondylolistheses, adult coliosis and other disorders of the lumbar spine. Spinal fusion cages (included in the general term, “fusion cages”) are inserted into the intervertebral disc space between two vertebrae for fusing them together. They distract (or expand) a collapsed disc space between two vertebrae to stabilize the vertebrae by preventing them from moving relative to each other.
The typical fusion cage is cylindrical, hollow, and threaded. Alternatively, some known fusion cages are unthreaded or made in tapered, elliptical, or rectangular shapes. Known fusion cages are constructed from a variety of materials including titanium alloys, porous tantalum, other metals, allograft bone, carbon fiber or ceramic material.
Fusion cages may be used to connect any adjacent portions of bone, however one primary use is in the lumbar spine. Fusion cages can also be used in the cervical or thoracic spine. Fusion cages can be inserted in the lumbar spine using an anterior, posterior, or lateral approach. Insertion is usually accomplished through a traditional open operation, but a laparoscopic or percutaneous insertion technique can also be used.
With any of the approaches, threaded fusion cages are inserted by first opening the disc space between two vertebrae of the lumbar spine using a wedge or other device on a first side of the vertebrae. Next, a tapered plug is hammered in to hold the disc space open in the case of a threaded, cylindrical cage insert. A threaded opening is then drilled and tapped on a second side opposite the first side of the vertebrae for producing the equivalent of a “split” threaded bore defined by the walls of the vertebrae above and below the bore. The threaded fusion cage is then threaded into the bore and the wedge is removed. The first side is then drilled and tapped before inserting a second threaded fusion cage. Typically, two threaded fusion cages are used at each invertebral disc level.
There are problems with all of the standard approaches. With a posterior approach, neural structures in the spinal canal and foramen need to be properly retracted before the plug is hammered or threaded into the disc space. Proper neural retraction is critical to the insertion process. If the retraction is not done properly, the procedure could cause neural injury, i.e., nerve damage and potential neurologic deficit. With either the anterior or lateral approach, blood vessels or other vital structures need to be retracted and protected to reduce or eliminate internal bleeding. Violation of the great vessels has a high mortality rate.
The general technique for inserting fusion cages is well known. Insertion techniques and additional details on the design of fusion cages is described in Internal Fixation and Fusion of the Lumbar Spine Using Threaded Interbody Cages, by Curtis A. Dickman, M. D., published in BNI Quarterly, Volume 13, No. 3, 1997, which is hereby incorporated by reference.
U.S. Pat. No. 5,782,832 to Larsen et al. (the “Larsen reference”) discloses an alternate type of spinal fusion implant.
Brett, U.S. Pat. No. 6,126,689 (2000), illustrates an expandable and collapsible fusion cage, but it design is extremely complex and therefore expensive to manufacture and prone to failure in the field. Moreover, its complex linkages require special surgical skills in its deployment. Indeed, there is no reliable deployment mechanism. The Brett design requires large hinges which make it too large and therefore unsuitable for posterior insertion.
Within the past several years there has been a dramatic resurgence of interest in interbody lumbar spinal fusions without disruption of the vertebral body endplate. Part of this renewed direction has been due to waning popularity in both anterior and posterior approach cylindrical cage fusions. Interbody fusion seems to be more reliable than the classic posterior lateral fusion for several reasons. First, the two endplates of the vertebral bodies are close together, and under compression toward each other. Second, there is a large surface area to fuse. Visualization of the nerve roots is easily done from any posterior approach.
Shortcomings have included difficulty getting lumbar Lordosis, and placing a large graft through a small hole. Trans-facet lateral fusion has recently been introduced to overcome the small hole problem. In this procedure the entire facet is removed making a much wider access to the anterior disk space. To combat the instability problems this would cause the procedure is usually done only from one side, and almost always combined with pedicle screws.
A major reason to further develop good posterior approach fusions is that it avoids the anterior surgical approach with all of its inherent risks. Indeed, it is the low but real incidence of major complications associated with the anterior surgical approach which is largely responsible for the decreasing popularity of anteriorly placed cylindrical cages.
What is needed is a simple, reliable and stable design for an insertable fusion cage and some type of inserting tool by which the implantation can be made without requiring extraordinary surgical skills which arise from the design of the fusion cage.
The invention is an apparatus for performing spinal fusions comprising two opposing end plates; and at least two opposing collapsible legs disposed between the two opposing end plates. The two opposing end plates and at least two opposing collapsible legs are adapted to be arranged and configured into an expanded cage from a collapsed configuration. The expanded cage assumes a predetermined rigid shape and volume for disposition between two adjacent vertebrae in a disk space therebetween. The collapsed configuration of the cage is adapted to being posteriorly inserted into the disk space while preserving the facet joint. The apparatus further comprises locking means for permanently or at least temporarily locking the legs and maintaining the cage in an expanded configuration.
More particularly there are three collapsible legs in which one of the three collapsible legs is medially disposed with respect to the end plates on a first side of the cage and two of the three collapsible legs are laterally disposed with respect to the end plates on a second side of the cage. The three legs have differing lengths so that the cage assumes a wedge-shaped envelope in the expanded configuration. The wedge-shaped envelope in the expanded configuration reestablishes a predetermined lordosis between fused vertebrae, which is a normal lumbar lordosis.
In the illustrated embodiment the opposing collapsible legs are each comprised of two segments hinged together at or near one end of each segment and hinged to one of the end plates at the opposing end of each segment. The hinge coupling the two segments together at or near one end of each segment flexibly connects the two segments of each leg together. The hinge comprises a flexible strap fixed to each of the two segments and extending between the two segments. Each leg has an exterior side forming part of the exterior of the envelope of the cage and the strap fixed to each of the two segments and extending between the two segments is disposed on the two segments on the exterior side thereof so that the pivot of the corresponding collapsible leg is exterior to the envelope of the cage. As a result, the locking means comprises an over-the-center toggle for each of the at least two opposing collapsible legs. The over-the-center toggle for each of the collapsible legs comprises a resilient strap having two opposing ends. Each opposing end of the resilient strap is coupled to one of the two opposing end plates. The strap is coupled to a corresponding collapsible leg so that when the cage is in the expanded configuration, the resilient strap applies a compressive force to the corresponding collapsible leg to maintain the corresponding collapsible leg in a locked configuration. The collapsible legs are each comprised of two segments hinged together at or near one end of each segment and hinged to one of the end plates at the opposing end of each segment and wherein each leg has an exterior side forming part of an exterior of an envelope of the cage and wherein the resilient strap is disposed on the two segments on the exterior side thereof. The two segments comprising a collapsible leg is coupled to the end plates by an open hinge.
The invention further comprises an inserter comprised of a tubular member having a distal end and holding clamp disposed on the distal end of the tubular member. The holding clamp is adapted to hold the cage in the collapsed configuration for insertion into a confined surgical theater of operation. Then on selective activation by the tubular member the cage is configured from the collapsed configuration to the expanded configuration. The activation of the tubular member the cage is permanently or at least temporarily locked into the expanded configuration. The inserter comprises a grip, and actuation or movement of the grip by a first amount configures the cage in the expanded configuration. Actuation or movement of the tubular member by a second successive amount locks the cage in the expanded configuration.
The tubular member comprises a hollow tubular housing and a telescopic rod disposed in the hollow tubular housing. The holding clamp is resiliently coupled to the tubular housing. The telescopic rod engages the holding clamp to manipulate the holding clamp to configure the cage from the collapsed configuration to the expanded configuration when the telescopic rod engages the holding clamp. The telescopic rod selectively engages the collapsible legs to configure the legs into a self-locked configuration.
The invention also comprises a method of using the cage and inserter described above to perform posterior spinal fusions.
While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112. The invention can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals.
The invention and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the invention defined in the claims. It is expressly understood that the invention as defined by the claims may be broader than the illustrated embodiments described below.
The spinal fusion cage of the invention comprises two opposing end plates, and three opposing collapsible legs. The two opposing end plates and three opposing collapsible legs are adapted to be configured into an expanded cage from a collapsed configuration. The expanded cage assumes a predetermined rigid shape and volume for disposition between two adjacent vertebrae. The collapsed configuration of the cage is adapted for posterior insertion into the disk space. The apparatus further comprises locking means for permanently or at least temporarily locking the legs and maintaining the cage in an expanded configuration. One of the legs is medially disposed on a first side of the cage and the other two are laterally disposed with respect to the end plates on a second side. The three legs have differing lengths so that the cage assumes a wedge-shaped envelope in the expanded configuration. The wedge-shaped envelope reestablishes a predetermined lordosis between fused vertebrae. The invention includes an inserter comprised of a tubular member and holding clamp disposed on the distal end of the tubular member. The holding clamp holds the cage in the collapsed configuration for insertion into a confined surgical theater. The cage is then reconfigured to the expanded configuration using the inserter. Further activation of the inserter causes the cage to be temporarily locked into the expanded configuration. Collapse and removal of the device, should that become necessary, is accomplished by squeezing the medial and lateral legs together using a standard surgical clamp.
Characteristics of the Expandable Lumbar Cage
Before describing the illustrated embodiment in detail and its method of deployment, first consider some general features, which characterize cage 10 of the invention. The device or expandable cage 10 of the illustrated embodiment easily fits into the disk space with minimal resection of the facet joints. About 10 mm in width is the maximum that will normally readily fit. The expandable cage 10 fits between the end plates of the vertebral bodies into the disk space. In this dimension 6 mm will go in comfortably in even difficult cases. The depth is about 25 mm (1 inch). This has been shown with many allografts to be a good universal length.
Once inserted into the disk space cage 10 should expand in height enough to distract the ligaments, open the neuroforimen, and stabilize the spine. Typically 10-14 mm is needed. The proposed device's expansion limit in the illustrated embodiment is 18 mm.
Once inserted cage 10 is expanded as described below into a wedged shape to reestablish normal lumbar lordosis. This is performed by expanding the deep end 12 of cage 10 more than the near end 14 as best shown in
Currently posterior lumbar interbody fusions (PLIFs) get around the natural disk space wedging by cutting a groove through the posterior vertebral bodies and end plates to create a rectangular groove for rectangular device or bone graft insertion, or by placing more graft or a vertical cage in the front of the disk space, or by cutting the graft into a wedge and then rotating into place once in the disk space. All of these methods, almost by necessity, must sacrifice the facet joint in order to get their large device into the disk space, cannot be rigid, or remove large portions of the weight bearing endplate.
Cage 10 of the invention once deployed must resist compression, rotation, as well as side to side and end to end rocking. It also includes a provision for removal as described below. Once deployed cage 10 is wide open thereby allowing large amounts of space for packing bone graft materials. Cage 10 is easy to manufacture, and to deploy reliably and consistently.
Structure of the Expandable Cage
In the illustrated embodiment cage 10 is a small (10 mm×6 mm×25 mm), expandable device suitable for inserting into the disk space from the spinal canal posteriorly. Cage 10 once expanded is open in the center, allowing ample space for placement of bone graft. Cage 10 may be made of several materials, however, titanium is preferred for strength, bone in-growth, modulus of elasticity, and MRI/X-ray/CT compatibility post-operatively.
Once deployed cage 10 expands to a maximum 18 mm in height (exact height must be selected before insertion as discussed below), and recreates about 11° of lumbar lordosis. Cage 10 is highly stable to all likely forces to which it will be subjected once it is deployed.
Cage 10 is comprised of two a top and a bottom exterior surface 16 and 18 respectively as shown in
Each of the legs 26 and 28 are composed of a segment 26 a or 28 a and its mirror image 26 b and 28 b in the case of legs 26 and 28 respectively, which segments joined at their adjacent ends by flexible adhesive or as shown in
The Expansion Process
An insertion device or inserter, generally denoted by reference numeral 36, and best shown and described below in connection with
Consider now in more detail the expansion of cage 10. Legs 26 and 28 are folded inside or between the top and bottom plates 20 and 22 as shown in the end view of
As the top and bottom plates 20 and 22 separate to assume the position shown in the end view of
The tautness of straps 24 and 30 also pushes the top and bottom ends 38 of legs 26 and 28 into the top and bottom plates 20 and 22. The top and bottom ends 38 of legs 26 and 28 use an open hinge for several reasons. First, these are very small structures. Placing a metal pin through them to make a standard hinge would take up far too much space, and weaken the structure. Second, the open hinge allows a more compact collapsed profile for cage 10. The open hinge allows for three-point fixation which greatly stabilizes and strengthens legs 26 and 28 once they are locked into place. Should removal be necessary, legs 26 and 28 of cage 10 are easily unlocked for removal.
The primary weight bearing surface is through the “shoulders” 40 of legs 26 and 28. The central portion 42 of legs 26 and 28 pushes toward the center or interior of cage 10, while the weight on cage 10 from the vertebrae, and the elasticity of straps 24 and 30 pull top and bottom plates 20 and 22 toward each other and tends to push legs 26 and 28 out or away from the center or interior of cage 10. Legs 26 and 28 are pushed out because the strap hinge 34 connecting the two halves 26 a and 26 b of leg 26 and the two halves 28 a and 28 b of leg 28 are outside of the center of rotation and the center of gravity of leg 26 and 28. Thus straps 24 and 30 rest in tension and weight bearing legs 26 and 28 oppose the tension, making cage 10 a very stable structure. As stated, the primary weight-bearing goes through both shoulders 40 of each leg 26 and 28.
One element in making cage 10 practical is having a reliable, simple method to open cage 10 and lock legs 26 and 28 open as described in connection with
As shown in
Cage 10 (not shown in
End to end stability has not been a problem with most grafts. Rolling or side to side stability is present because of the cantilevered hinges or ends 38 which cannot rotate once cage 10 is deployed. Half of the hinges or ends 38 are always resisting any side-to-side moment.
Because cage 10 is essentially open, there is ample space for bone grafting. What this allows is stable interbody fusion in the spine from the back, while preserving the facet joints. In applications where cage 10 is exceptionally stable, then it is possible to use cage 10 for stand alone fusions, obviating the need for pedicle screws.
The Use of the Cage in Lumbar Fusions
Cage 10 and inserter 36 and their operation now having been described in detail, consider how they are used in an actual posterior interbody lumbar fusion.
The same procedure is performed on the opposing side of the endplates of vertebrae 66 and 68 to dispose a pair of cages 10 in a balanced manner on each side of the spinal cord and to provide stable support. Bone graft material and/or other medicaments are then disposed in disk space 90 and into the interior of cages 10 to complete the lumbar fusion in a conventional manner.
The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.
Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.
The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.
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|U.S. Classification||623/17.11, 623/17.12, 606/99, 623/17.15, 606/90|
|International Classification||A61F2/44, A61F2/30, A61F2/46, A61F2/00|
|Cooperative Classification||A61F2002/4623, A61F2/447, A61F2002/30551, A61F2/4611, A61F2220/0025, A61F2002/30266, A61F2220/0075, A61F2220/0091, A61F2002/30471, A61F2002/30505, A61F2002/30601, A61F2002/4635, A61F2002/4475, A61F2002/4627, A61F2002/30464, A61F2002/3055, A61F2310/00023, A61F2002/30476, A61F2230/0082|
|European Classification||A61F2/44F6, A61F2/46B7|
|Apr 18, 2002||AS||Assignment|
Owner name: REGENTS OF THE UNIVERSITY OF CALIFORNIA, THE, CALI
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KIESTER, P. DOUGLAS;REEL/FRAME:012815/0260
Effective date: 20020219
|Nov 17, 2008||FPAY||Fee payment|
Year of fee payment: 4
|Dec 31, 2012||REMI||Maintenance fee reminder mailed|
|May 17, 2013||LAPS||Lapse for failure to pay maintenance fees|