1. Field of the Invention
The present invention relates generally to fusion cage medical devices. More particularly, the present invention relates to an expandable fusion cage.
2. Description of the Prior Art
A small but significant percentage of the population experiences chronic back pain related to spinal disorders. Commonly, a patient experiences pain caused by degeneration of intervertebral discs, which reside between adjacent vertebrae. Motion in a patient's spine occurs between adjacent vertebrae through the disc, which lies between anterior portions of adjacent vertebrae, and facet joints, which lie on either side of posterior portions of the vertebrae. As the disc degenerates, the nucleus of the disc becomes thinner and less able to accommodate compression between the vertebrae. When the nucleus becomes thinner, the annulus of the disc handles abnormal compression loads and the annulus also is less able to control spinal movement. As a result, the patient may experience pressure on nerves from the disc bulging into the nerve passageways, damage or tears to the disc, and disc herniation. These conditions result in arthritis of the facet joints, back pain, and nerve injury.
To alleviate pain from these conditions, surgeons may fuse together adjacent vertebrae using a bone grafting method. To immobilize the spine and allow adjacent vertebrae to grow together, a hollow spinal “cage” is placed in the disc space between vertebrae on either side of the spinal column after removing part of the disc. Typically, a bone graft material is inserted within the hollow cage to enhance the “growth” of two or more vertebrae together. Taking on one of the disc's functions, the cage maintains the space between vertebrae.
When a cage is inserted posteriorly, it must be sized to fit between the superior and inferior endplates of adjacent vertebrae. These endplates are often not parallel in the lumbar vertebrae due to curvature of the spine, or lordosis. The disc space between vertebrae tapers from the anterior portion to the posterior portion. In other words, the vertical distance between posterior endplates is typically smaller than the vertical distance between anterior endplates. Because the posterior spacing is smaller, the surgeon may have to use a cage with parallel superior and inferior surfaces, which fit loosely at the anterior side and tightly at the posterior side; insert the cage where the patient's spine is not curved; or insert the spinal cage anteriorly. All of these options are non-ideal.
Several variations in spinal cages have been developed in an attempt to overcome the problems with posterior placement of a spinal cage. One expandable intervertebral cage, described in U.S. Pat. No. 6,814,756 to Michelson, has a cylindrical body formed by an upper body portion, and a lower body portion. The upper body portion and lower body portion are hinged at a posterior end. Anterior ends of the upper and lower body portions are spread apart using an extrinsic tool. The upper and lower body portions are then held in an expanded position by positioning a blocker between anterior portions of the upper and lower body portions.
Another spinal cage, described in U.S. Pat. No. 6,491,724 to Ferree, includes either a passive or an active expansion mechanism in a box-like intervertebral cage. Passive expansion mechanisms include making the cage of a material with a shape memory that causes the cage to naturally expand from a compressed state to an expanded state once the cage is positioned within the intervertebral space. An active expansion mechanism has an externally-accessible mechanism that is used to increase the anterior height of the cage once it is positioned within the intervertebral space. One active mechanism has a slug positioned on a threaded rod within the cage. The cage is hinged at its posterior end. The slug moves posterior to anterior when the rod is rotated, causing the upper member of the cage to hinge and move upwardly to assume a wedge-shaped orientation.
Another cage device, described in U.S. Pat. No. 6,443,989 to Jackson, has a box-like body with upper and lower walls. The upper and lower walls are joined at a rear wall that functions as a spring hinge. The upper and lower walls have anterior ends that are supported in a non-expanded configuration by spaced-apart feet that project out from the walls. Received in the rear wall of the cage is an elongate, threaded expansion member that has a head with an anterior wedge portion. The wedge portion engages the anterior ends of the walls and forces the walls apart as the expansion member is screwed into the body to advance the wedge portion towards the anterior ends.
Currently-available devices described above exhibit various disadvantages. Cylindrical devices require a reamed channel in the vertebral bone between vertebrae, which weakens the bone. Also, other cylindrical devices open radially at the anterior end of the fusion cage, which is undesirable if lateral expansion is not needed. Existing rectangular cages have a piston-type mechanism extending through the cage body to cause the upper and lower portions of the device to expand. The action of the piston-like mechanism on the unsecured cage forces the device out of position in the direction of the piston's movement. Therefore, what is needed is an improved expandable fusion cage for expanding the anterior portion of the cage.
It is an object of the present invention to provide an expandable fusion cage device for posterior placement between adjacent vertebrae.
It is another object of the present invention to provide an expandable fusion cage that may be adjusted from a collapsed position to an expanded position.
It is another object of the present invention to cause expansion of the fusion cage without using a piston-like device that extends through the cage body.
It is another object of the present invention that the anterior cage expansion occurs by adjusting the device from the posterior end of the fusion cage.
The present invention achieves these and other objectives by providing an expandable fusion cage with a cam adjuster. In one embodiment, the expandable fusion cage has an elongated cage body with a posterior end, an anterior end, and a central hollow region extending along a central longitudinal axis of the cage body. The posterior end has an access opening therethrough in communication with the hollow region. The anterior end has a first anterior end portion and a second anterior end portion. A first longitudinal member extends between the posterior end and the first anterior end portion substantially parallel to the central longitudinal axis. A second longitudinal member extends between the posterior end and the second anterior end portion substantially parallel to the central longitudinal axis. A cam body has a cam surface on a periphery of the cam body and a cam adjusting feature facing the central hollow region where the cam body is positioned between the first anterior end portion and the second anterior end portion. The cam body is adapted to rotatably engage the cam surface with the first anterior end portion and the second anterior end portion to change the orientation of the anterior end of the cage body between a collapsed configuration and an expanded configuration, where the cam body has at least one engagement feature for rotating the cam body.
In another embodiment of the present invention, the cam body is substantially oblong.
In another embodiment of the present invention, the cam adjusting feature includes one of more structures such as a recessed structure or a protruding structure.
In another embodiment of the present invention, the protruding structure has a rectangular adjustment member and a cam shaft, where the cam shaft extends substantially parallel to the central longitudinal axis of the elongated cage body and is fixedly attached between the cam body and the rectangular adjustment member.
In another embodiment of the present invention, the first anterior end portion and the second anterior end portion is in a collapsed configuration and defines an open region therebetween. The open region extends along the central longitudinal axis at least partially through at least one of the first anterior end portion and the second anterior end portion. The open region is shaped and configured for rotatable interaction with the cam body.
In another embodiment of the present invention, the open region also includes at least one locking notch configured to receive an end of the cam body.
In another embodiment of the present invention, at least one of the first anterior end portion and the second anterior end portion has an end wall adjacent to the open region and extending substantially perpendicular to the central longitudinal axis.
In another embodiment of the present invention, the cam body includes a cam retainer configured to retain the cam body between the first anterior end portion and the second anterior end portion.
In another embodiment of the present invention, the first elongated member and/or the second elongated member includes a pair of spaced-apart members.
In another embodiment of the present invention, one or both of the first longitudinal member and the second longitudinal member is hingedly attached to the posterior end.
In another embodiment of the present invention, the first longitudinal member and the second longitudinal member are fixedly attached to the posterior end. One of the posterior end or a junction between the posterior end and each of the first and second longitudinal members is bendable to permit the anterior end of the fusion cage to convert from a collapsed configuration to an expanded configuration upon rotation of the cam body.
In another embodiment of the present invention, the cage body is made of a biocompatible material.
The preferred embodiments of the present invention are illustrated in
In a collapsed configuration, anterior end 110 has a height h1 measured vertically across first anterior end portion 122 and second anterior end portion 142. First anterior end portion 122 may or may not contact second anterior end portion 142 in the collapsed position. Posterior end 105 of cage body 100 has a height h2.
In one embodiment, one or both of first longitudinal member 120 and second longitudinal member 140 are hingedly attached to posterior end 105 of cage body 100. In another embodiment, first posterior end portion 132 and/or second posterior end portion 152 are hingedly connected to each other or to one or more portions 161a, 161b of a posterior body 160 that joins first longitudinal member 120 and second longitudinal member 140.
In another embodiment, first longitudinal member 120 and second longitudinal member 140 are fixedly attached or integral to posterior end 105 of cage body 100. In either embodiment, it is contemplated that a junction 200 between first longitudinal member 120, second longitudinal member 140 and posterior body 160, or posterior body 160, is bendable to permit cage body 100 to convert from a collapsed configuration to an expanded configuration. For example, materials used to construct cage body 100 are preferably sufficiently flexible or thin enough at the bendable junction to permit first and/or second longitudinal members 120, 140 to pivot vertically about posterior end 105 (without requiring a hinge or similar device) to convert cage body 100 between the collapsed configuration and the expanded configuration.
Materials for cage body 100 include biocompatible materials such as, for example, stainless steel, cobalt-chromium-molybdenum alloys, titanium, carbon-reinforced polymers, shape memory alloys, and nylon or other fiber or polymeric materials as described in U.S. Pat. No. 5,192,327, which is incorporated herein by reference in its entirety. Carbon-reinforced polymers include alloys of copper and zinc, nickel titanium, silver and cadmium, and other metals as described in U.S. Pat. No. 5,954,725, which is incorporated herein by reference in its entirety.
In one embodiment, lower or first longitudinal member 120 includes a pair of spaced-apart elongated legs 120a, 120b that extend between first anterior end portion 122 and first posterior end portion 132 of cage body 100. Elongated legs 120a, 120b each extend substantially parallel to central longitudinal axis 115 and are connected at a posterior end 105 by first posterior end portion 132 and at anterior end 110 by first anterior end portion 122. Being spaced apart, elongated legs 120a, 120b define at least one gap or opening 121 between them. Opening 121 is bounded by first anterior end portion 122, first posterior end portion 132, and elongated legs 120a, 120b.
Similarly, second longitudinal member 140 in one embodiment includes a pair of spaced-apart elongated legs 140a, 140b that extend between second anterior end portion 142 and second posterior end portion 152 of cage body 100. Elongated legs 140a, 140b each extend substantially parallel to central longitudinal axis 115 and are connected at posterior end 105 by second posterior end portion 152 and at anterior end 110 by second anterior end portion 142. Elongated legs 140a, 140b define at least one gap or opening 141 between them. Opening 141 is bounded by first anterior end portion 142, first posterior end portion 152, and elongated legs 140a, 140b.
In another embodiment, first longitudinal member 120 and/or second longitudinal member 140 is a generally plate-like or planar structure that extends between first anterior end portion 122 and first posterior end portion 132. In such an embodiment, first longitudinal member 120 preferably has one or more openings 121 and second longitudinal member 140 also preferably has one or more openings 121. Openings 121, 141 allow bone growth between adjacent vertebrae through cage body 100 to bone graft material introduced into a central hollow portion 102 within cage body 100.
Access opening 162 is preferably centered on posterior body 160, but this does not have to be the case. In some embodiments, it may be preferable to position access opening 162 more towards one side of posterior body 160 to permit the user to access the cam adjustment assembly at an angle. In one embodiment, access opening 162 has a generally-oval shape with a pair of opposed straight sides 162a, 162b and a pair of opposed arcuate sides 162c, 162d. Access opening 162 may have other shapes, such as round, rectangular, oval, polygonal, and simple or complex combinations of these shapes so long as the user has sufficient access to the cam adjusting feature 350 to adjust the cam adjustment assembly 300 to convert cage body 100 between a collapsed configuration and an expanded configuration.
Referring to
As also shown in
Similarly, anterior end 110 preferably has a second cam recess 150 that extends along central longitudinal axis 115 partially or completely through second anterior end portion 142 to define second end wall 144. In one embodiment, second cam recess 150 extends partially into second anterior end portion 142 to define a second end wall 144 at an inside anterior end surface 110a (shown in
As illustrated in
In the various embodiments discussed above and as shown in
In addition to first cam recess 130, first anterior end portion 122 preferably has a first anterior opening 134 extending through first end wall 124 and first wall end surface 128. Similarly, second anterior end portion 142 additionally or alternately has a second anterior opening 154 extending through second end wall 144 and second wall end surface 148. First anterior opening 134 and second anterior opening 154 are preferably semi-circular in shape, but may have other shapes, such as rectangular, curved, polygonal, and combinations of these shapes. It is understood that if other shapes are used, the minor diameter of the shape of first anterior opening 134 and second anterior opening 154 must be larger than a shaft of a cam assembly to allow rotation of a cam shaft 330 (not shown). When cage body 100 is in its collapsed configuration as shown in
As illustrated in
As illustrated, cam body 310 is in a horizontal position where anterior end 110 is in a collapsed configuration. In an intermediate expanded configuration as shown in
In
Cam retainer 302 has a flat posterior retainer face 304 that is preferably round or oval. Retainer face 304 has a diameter or major diameter 305a that is sized to be similar or equal to height h1 of anterior end 110 of cage body 100. Major diameter 305a is greater than any dimension across open region 170 between first anterior end portion 122 and second anterior end portion 142 when cage body 100 is either in a collapsed or expanded configuration. For embodiments where retainer face 304 is oblong, retainer face 304 has a minor diameter 305b. Cam retainer 302 also has a retainer body 306 that is anterior to retainer face 304.
Cam body 310 is preferably oblong in shape and has a posterior face 312 and an anterior face 313 (not visible) on opposite sides of cam body 310. Posterior and anterior faces 312, 313 each have a major diameter 315a and a minor diameter 315b. At the opposite ends of major diameter 315a, cam body 310 has a first end 316 and a second end 318, respectively. Cam body has a thickness 320 between posterior face 312 and anterior face 313. Cam body 310 is sized and shaped to fit within hollow region 170 between first anterior end portion 122 and second anterior end portion 142.
Another embodiment of cam body 310 includes multiple protrusions 322 spaced around its perimeter. The radius to the extent of each protrusion 322 generally increases to enable the user to rotate cam body 310 a small amount (e.g., ⅛ or ¼ of a revolution) to select the amount of expansion at anterior end 110 desired. Rather than having first locking notch 136 and second locking notch 156 on anterior end 110, cam body 310 may optionally include one or more recesses 324 along an outer perimeter surface 119 to lock with a protrusion (not shown) on anterior end 110 of cage body 100 for locking cage body 100 in an expanded position. Protrusions 322 and/or recesses 324 may be of different sizes to provide multiple expanded positions where each expanded position provides a pre-determined vertical separation between first anterior end 122 and second anterior end 142.
Cam shaft 330 is preferably a disc or cylinder that is fixedly attached on its anterior end 336 to posterior face 312 of cam body 310 and on its posterior end 334 to cam adjustment member 352. Shaft 330 has a diameter 331 and a length 332 each sized to allow shaft 330 to extend through cam shaft opening 164 of anterior end 110 of cage body 100. Diameter 331 of shaft 330 is preferably slightly smaller than diameter 165 of cam shaft opening 164 (shown in
Cam adjustment member 352 is fixedly connected to posterior end 334 of shaft 330 and resides on the interior of cage body 100 close to or against first inside surface 126 of first end wall 124 and second inside surface 146 of second end wall 144. Cam adjustment member 352 preferably has a substantially flat rectangular shape with a pair of longer sides 352a, 352b, a pair of shorter sides 354a, 354b, and a thickness 356 between a posterior face 358 and an anterior face 360. A rectangular shape allows the user to engage sides of cam adjustment member 352 to rotate it and therefore to rotate cam body 310 whose cam surface 310a on the periphery of cam body 310 engages the corresponding cam surfaces of the anterior end 110. Because expandable spinal cage 10 is positioned within the human body and surrounded by tissue, bone, and the like, a rectangular shape also makes it easier for the user to determine by visual inspection whether the position of cam body 310 corresponds to the collapsed configuration or the expanded configuration of cage body 100.
Cam adjustment member 352 is not limited to the shape of a rectangular block. In other embodiments, cam adjustment member 352 has the general shape and appearance of a flanged nut, such as a flanged hex nut. Rather than having a central threaded opening of a typical flanged hex nut, however, cam adjustment member 352 shaped like a flanged nut is preferably fixedly attached to shaft 330 at its anterior, flanged portion. In this embodiment, the user may engage the sides of the polygonal (e.g., hexagonal) nut portion to rotate cam adjustment member 352 and therefore cam body 310. The round, flanged portion of flanged-nut-shaped adjustment member 352 maintains the position of cam body 310 in a fashion similar to that of rectangular adjustment member 352 described above.
When cam body structure 322 is formed in cam body 310 as illustrated in
In use, fusion cage 10 is positioned between adjacent vertebrae of a patient where the vertebrae are accessed posteriorly (i.e., from the patient's back). Cage 10 is positioned so that anterior end 110 of cage body 100 may be subsequently expanded. After cage body 100 is positioned in its collapsed configuration between adjacent vertebrae, the user then inserts an adjustment tool through access opening 162 to cam adjustor assembly 300. By engaging engagement feature 322 of cam body 310, such as a socket placed over cam adjustment member 352, the user rotates adjustment member 352 to cause cam body 310 to also rotate within open region 170 between first anterior end portion 122 and second anterior end portion 142.
Because cam body 310 is generally oblong, its rotation causes anterior end of cage body 100 to expand and increasing the distance between first anterior end portion 122 and second anterior end portion 142. As cam body 310 further rotates, first end 316 and/or second end 318 of cam body 310 occupy first locking notch 136 and second locking notch 156, respectively. Pressure exerted on anterior cage body 100 from anterior portions of the patient's vertebrae bias cage towards its collapsed position, which prevents first end 316 and second end 318 of cam body 310 from freely rotating out of first locking notch 136 and second locking notch 156, respectively. Cage may also be constructed of resilient materials that also bias cage towards its collapsed configuration. Fusion cage 10 may be positioned between adjacent vertebrae by accessing the vertebrae posteriorly where the space between adjacent vertebrae is smaller than the corresponding space between anterior portions of the vertebrae. Fusion cage 10 may subsequently be expanded at its anterior end 110 to provide a snug fit between the vertebrae when the patient's spine is positioned to have the desired lordosis.
Although the preferred embodiments of the present invention have been described herein, the above description is merely illustrative. Further modification of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention as defined by the appended claims.