1. Technical Field
The embodiments herein generally relate to medical devices, and, more particularly, to medical devices for the spine.
2. Description of the Related Art
One of the most costly health problems to society involves back pain and pathology of the spine, which can be caused by several factors. These problems can affect individuals of all ages and can result in great suffering to victims.
Upon identification of these abnormalities, surgery may be required to correct the problem. One method of correction is spinal fusion, wherein vertebrae are fixed together to prevent movement and maintain a space originally occupied by an intervertebral disk. During a spinal fusion, a prosthetic implant or spinal implant is inserted into the intervertebral space. Although this procedure may result in some minor loss and flexibility in the spine, due to the relatively large number of vertebrae, the minor loss of mobility is typically acceptable.
Most commonly, a manufactured implant biologically compatible with the body and the vertebrae, is made of a synthetic material. Several compositions and geometries of such implants have been is utilized, ranging from simple blocks of material to carefully shaped implants, with varying success. There, has been an extensive number of attempts in developing an acceptable prosthetic implant that can be used to replace an intervertebral disk and yet maintain the stability of the intervertebral disk spaced between adjacent vertebrae. Examples of some conventional systems are described in U.S. Pat. No. 6,849,093 and U.S. Pat. No. 7,326,248, the complete disclosures of which, in their entireties, are herein incorporated by reference.
While many types of synthetic prosthetic devices have been proposed, the success ratio has been low and the surgical procedures have been complicated and often traumatic to the patient. Although intervertebral fusion is widely used, drawbacks to their use include a reduced physiologic range of motion and other fusion related complications such as degeneration of adjacent discs and destabilization of the functional spinal unit. As a result, alternative treatments with fewer complications, but similar efficacy to fusion, are desirable.
In view of the foregoing, an embodiment herein provides a system having an expandable intervertebral fusion implant assembly for insertion between two vertebrae bodies. The system includes an anterior lumbar interbody component having an upper component and a lower component, the upper component and the lower component each having an inner and outer surface. The upper and lower components are pivotally connected through a hinge. A distracting component including a wedge having a superior and inferior surface inserts between the upper and lower components of the anterior lumbar interbody component. The outer surface of the upper and the lower component contact endplates of two adjacent vertebral bodies.
The outer surface of the upper component and the lower component each include a vertebrae position device at a first end proximal to the hinge. The upper and the lower component include textured area terminating at the vertebrae position device and a rib proximal to the first end. The distracting component includes a securing component continuous with the wedge, wherein the securing component extends substantially perpendicular from the wedge. The securing component includes a first and second fixation hole traversing the securing component, wherein the first and second fixation holes are positioned on an upper section and a lower section of the securing component, wherein the wedge is positioned between the upper section and the lower section. The securing component includes a bendable metal to accommodate curvature of vertebrae bodies. The distracting component has at least one alignment fin proximal to the wedge. The upper and the lower component each have at least one fin guide positioned complementary to the at least one alignment fin proximal to the wedge. The superior and inferior surfaces of the wedge are angled. The second end of the upper and the lower component is contoured to the shape of the securing component. The anterior lumbar interbody component is substantially D-shaped.
Another embodiment provides an expandable intervertebral fusion implant apparatus for insertion between two vertebrae bodies including an anterior lumbar interbody component having an upper component and a lower component. The upper component and the lower component each have an inner and outer surface, wherein the upper and lower components are pivotally connected through a hinge. A distracting component has a wedge having a superior and inferior surface, wherein the wedge inserts between the upper and lower components of the anterior lumbar interbody component. A second end of the upper and the lower component each have a bone screw guide, wherein the bone screw guide is angled.
The distracting component includes a securing component continuous with the wedge via an extension bar, wherein the securing component extends substantially perpendicular from the wedge. The securing component is substantially square shaped having a top edge and a bottom edge, wherein the top edge and the bottom edge are substantially aligned with the outer surface of the upper component and the lower component. The securing component includes a first and second fixation hole traversing the securing component, wherein the first and second fixation holes are positioned diagonally on the securing component. The wedge is positioned substantially in the middle of the securing component. The fixation holes are angled complementary to the angled bone screw guides. A second end of the upper and the lower component is contoured to the shape of the securing component. The superior and inferior surfaces of the wedge are angled.
Yet another embodiment provides an expandable intervertebral fusion implant assembly for insertion between two vertebrae bodies including an anterior lumbar interbody component having an upper component and a lower component. The upper and lower components are pivotally connected through a hinge. A distracting component includes a wedge that inserts between the upper and lower components of the anterior lumbar interbody component, a vertebrae position device at a first end proximal to the hinge, a rib proximal to the first end, a securing component continuous with the wedge, a first and second fixation hole traversing the securing component, at least one alignment fin proximal to the wedge, and at least one fin guide positioned complementary to the at least one alignment fin proximal to the wedge.
These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.
The embodiments herein will be better understood from the following detailed description with reference to the drawings, in which:
The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
The embodiments herein provide an expandable intervertebral fusion implant for insertion between two vertebrae; comprising of an open superior (upper) and inferior (lower) component, that are pivotally connected through a hinge, and distracting component that comprises of a wedge that is adapted to engage/move apart the upper and lower components to contact the endplates of the vertebral bodies. The device allows the surgeon to adapt/adjust the angle of the implant to help accommodate the intervertebral disc space with a more concise fit. Referring now to the drawings, and more particularly to
A first embodiment herein, illustrated in
The outer surfaces 14A, 16A of the upper component 14 and the lower component 16 each include a vertebrae position device 24 at a first end 26 proximal to the hinge 18. The vertebrae position device 24 allows for an improved fit and reduction of movement of the assembly 10. The addition of a textured feature 28 on the outer surfaces 14A, 16A of the upper component 14 and the lower component 16, further reduces movement of the system 10 upon installation. Further, referring to
As further shown in
The distracting component 20 includes at least one alignment fin 36X proximal to the wedge 22 positioned complementary to at least one alignment fin guide 38X on the upper 14 and/or lower 16 component of the interbody component 12. It is appreciated that the exact number and location of alignment fins 36X and complementary alignment fin guides 38X could vary without diverting from the basic concept of a complementary locating and “fit” means for combining the anterior lumbar interbody component 12 and distracting component 20.
Preferably, the superior 22A and inferior 22B surfaces of the wedge 22 are configured to form an angle of approximately 10.0 degrees to 20.0 degrees. Referring to
Referring to
The distracting component 120 further includes a securing component 132 continuous with the wedge 122 via an extension bar 154, wherein the securing component 132 extends substantially perpendicular to the wedge 122. The securing component 132 is substantially square shaped having a top edge 133 and a bottom edge 135, which are substantially aligned with the outer surface 114A, 116A of upper component 114 and the lower component 116. The securing component 132 includes a fixation hole 134 traversing the securing component 132. The fixation hole 134 is positioned centrally on the securing component 132. Additionally, a pair of corner fixation holes 146, 148 are positioned on opposite corners of the securing component 132 such that the holes 134, 146, 148 are diagonally positioned on the securing component 132. The holes 146, 148 are aligned with the respective angled bone screw guides 150, 152. The wedge 122 is positioned between substantially centrally from the back end 138 of the securing component 132. As with the previous embodiment, the second end 140 of the upper 114 and the lower 116 component is contoured to the shape of the securing component 132.
Similar to the previous embodiment, the superior 122A and inferior 122B surface of the wedge 122 form an angle of approximately 10° to 20°. Further, the wedge 122 would be of one size for each distracting component 120 and would be designated as required by the patient's procedure as recognized by a surgeon. It will be recognized by those of skill in the art that the hinge 118 would “opens” allowing movement of the upper 114 and lower 116 component so as to accommodate the “shape” of the wedge 122 upon insertion.
The outer surfaces 114A, 116A of the upper component 114 and the lower component 116 each include a vertebrae position device 124 at a first end 126 proximal to the hinge 118. The vertebrae position device 124 allows for an improved fit and reduction of movement of the assembly 110. The addition of a textured feature 128 on the outer surfaces 114A, 116A of the upper component 114 and the lower component 116, further reduces movement of the assembly 110 upon installation. The upper 114 and lower 116 component each comprise a graft containment guide 130 proximal to the first end 126 and a graft containment area 137.
In
The outer surfaces 214A, 216A of the upper component 214 and the lower component 216 each include a vertebrae position device 224 at a first end 226 proximal to the hinge 218. The vertebrae position device 224 allows for an improved fit and reduction of movement of the assembly 210. The addition of a textured feature 228 on the outer surfaces 214A, 216A of the upper component 214 and the lower component 216, further reduces movement of the system 210 upon installation. The upper 214 and lower 216 component each comprise of a rib 230 proximal to the first end 226 and a graft containment area 237. Rib 230 provides the anterior lumbar interbody component 212 torsional stiffness.
A distracting component 220 includes a securing component 232 continuous with a wedge 222, wherein the securing component 232 extends substantially perpendicular to the wedge 222. The securing component 232 includes a centrally positioned fixation hole 234 traversing the securing component 232. Upon attachment of the apparatus 210, a screw (not shown) would contact the compacted bone graft material that is inserted into the graft containment area 237. Since the bone graft material allows the bone to regenerate, the screw would then become anchored in the newly formed regenerated bone. Additionally, an angled fixation hole 246 is located on the upper portion 232A of the securing component 232 to secure the securing component 232 to a vertebrae 1000 (as illustrated in the previous embodiment in
The extended lower portion 216E extending from the lower component 216, has increased thickness of the bone screw guide 250E to allow additional depth to secure a screw (not shown) traversed therein. Further, the position of the extended lower portion 216E defines a contour 216C to the shape of the lower portion 232B of the securing component 232 allowing additional support. Moreover, a screw (not shown) fits in the fixation hole 246 when the apparatus 210 is attached to the vertebrae 1000.
In
The outer surfaces 314A, 316A of the upper component 314 and the lower component 316 each include a vertebrae position device 324 at a first end 326 proximal to the hinge 318. The vertebrae position device 324 allows for an improved fit and reduction of movement of the assembly 310. The addition of a textured feature 328 on the outer surfaces 314A, 316A of the upper component 314 and the lower component 316, further reduces movement of the system 310 upon installation. The upper 314 and lower 316 component each comprise of a rib 330 proximal to the first end 326 and a graft containment area 337. Rib 330 provides the anterior lumbar interbody component 312 torsional stiffness.
A distracting component 320 includes a securing component 332 continuous with a wedge 322, wherein the securing component 332 extends substantially perpendicular to the wedge 322. The securing component 332 includes a centrally positioned fixation hole 334 traversing the securing component 332. Upon attachment of the apparatus 310, a screw (not shown) would contact the compacted bone graft material that is inserted into the graft containment area 337. Since the bone graft material allows the bone to regenerate, the screw would then become anchored in the newly formed regenerated bone.
Each extended lower portion 314E, 316E extends from the upper component 314 and lower component 316, respectively, and allows increased thickness of the bone screw guides 350E, 352E to allow additional depth to secure a screw (not shown) inserted therein. Further, the position of the extended portions 314E, 316E define a contour 314C, 316C to the shape of the upper portion 332A and lower portion 332B of the securing component 332, allowing additional support.
The assembly 10, 110 is intended to be used in the anterior lumbar spine as an intervertebral fusion device.
Referring to
Referring to
Generally, the embodiments herein provide an expandable intervertebral fusion implant assembly 10, 110, 210, 310 for insertion between two vertebrae bodies 1000 and include an anterior lumbar interbody component 12, 112, 212, 312 comprising an upper component 14, 114, 214, 314 and a lower component 16, 116, 216, 316, wherein the upper 14, 114, 214, 314 and lower 16, 116, 216, 316 components are pivotally connected through a hinge 18, 118, 218, 318. The assembly 10, 110, 210, 310 further includes a distracting component 20, 120, 220, 320 that comprises a wedge 22, 122, 222, 322 that inserts between the upper 14, 114, 214, 314 and lower 16, 116, 216, 316 components of the anterior lumbar interbody component 12, 112, 212, 312. A vertebrae position device 24, 124, 224, 324 is positioned at a first end 26, 126, 226, 326 proximal to the hinge 18, 118, 218, 318. A rib 30, 130, 230, 330 is positioned proximal to the first end 26, 126, 226, 326. A securing component 32, 132, 232, 332 is continuous with the wedge 22, 122, 222, 322, and a first 34A, 146, 246, 334 and second 34B, 148, 234 fixation hole traverses the securing component 32, 132, 232, 332. At least one alignment fin 36X is positioned proximal to the wedge 22, and at least one fin guide 38X is positioned complementary to the at least one alignment fin 36X proximal to the wedge 22.
The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.