Spinal cage device, system, and methods of assembly and use

Spinal cage devices, systems, and methods of assembly and implanting the devices and systems are disclosed. The cage system includes a cage and at least one locking screw assembly configured to couple to the cage. The spinal cage system includes a cage with a body portion, an external plate, and a rod. The body portion includes at least one opening positioned between the first and second ends, a center opening in the first end, and at least one hole adjacent the center opening. The external plate includes an opening and at least two holes on opposite sides of the opening. The rod extends through the center opening in the cage, the first end configured to couple to the external plate, and the second end positioned in the at least one opening. Methods for assembling a spinal cage system and for implanting a cage system are also disclosed.

TECHNICAL FIELD

The present disclosure relates generally to orthopedic and neurosurgical implants and systems for insertion between two vertebral bodies in a patient's spine. More specifically, the present disclosure relates to spinal cage devices, systems, and methods of assembly and use.

BACKGROUND

Spinal cages are designed to be inserted between two vertebrae in a patient's spine to restore or maintain the spacing between two vertebrae. The cages may be designed to attach to the vertebrae in various configurations which generally involve the use of bone screws.

Currently available spinal cages may experience bone screw back out which may cause destabilization of the spinal cage between the two vertebrae if fusion has not yet occurred. Additionally, as screws back out of the spinal cages they may interact with surround tissue and cause further complications for the patient.

Thus, the currently available spinal cages may cause additional complications to a patient and new spinal cages are needed to prevent additional damage from occurring to the patient.

SUMMARY

Aspects of the present invention provide spinal cage devices, systems, and methods of assembly and use that can be used to facilitate proper alignment of a patient's spine.

In one aspect, provided herein is a cage system including a cage and at least one locking screw assembly configured to couple to the cage.

In another aspect, provided herein is a spinal cage system, including a cage, an external plate, and a rod. The cage may include a body portion with a first end and a second end. The body portion may also include at least one opening positioned between the first end and the second end, a center opening in the first end and positioned relatively perpendicular to the at least one opening, and at least one hole positioned adjacent to the center opening. The external plate may include an opening and at least two holes positioned on opposite sides of the opening. The rod may also have a first end and a second end and may extend through the center opening in the cage. The first end of the rod is configured to couple to the external plate and the second end is positioned in the at least one opening.

In yet another aspect, provided herein is a method of assembling a spinal cage system including obtaining a cage, an external plate, a rod, and at least one locking mechanism. The method may also include inserting the rod into the cage. In addition, the method may include attaching a first locking mechanism of the at least one locking mechanism to a portion of the rod in the cage. Further, the method may include attaching the external plate to a portion of the rod outside of the cage.

In a further aspect, provided herein is a method of implanting a cage system in a patient's spine, including placing an incision over the spine and preparing the spine for receiving the cage system. The method may also include obtaining a cage system with a cage, at least one fastener, and at least one locking member. The method may further include inserting the cage into the spine and aligning the cage relative to two adjacent vertebral bodies. In addition, the method may include evaluating the position of the cage and inserting at least one fastener through the cage into one of the two adjacent vertebral bodies. The method may also include positioning the at least one locking member in the cage adjacent to the fastener. Further, the method may include activating the at least one locking member to secure the at least one fastener in the cage. Finally, the method may include closing the incision.

DETAILED DESCRIPTION OF EMBODIMENTS

Generally stated, disclosed herein are embodiments of spinal cage devices and systems. Further, methods of assembling and using the spinal cage devices and systems are discussed.

In this application, the words proximal, distal, anterior, posterior, medial and lateral are defined by their standard usage for indicating a particular part or portion of a bone or prosthesis coupled thereto, or directional terms of reference, according to the relative disposition of the natural bone. For example, “proximal” means the portion of a bone or prosthesis nearest the torso, while “distal” indicates the portion of the bone or prosthesis farthest from the torso. As an example of directional usage of the terms, “anterior” refers to a direction towards the front side of the body, “posterior” refers to a direction towards the back side of the body, “medial” refers to a direction towards the midline of the body and “lateral” refers to a direction towards the sides or away from the midline of the body.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference toFIGS. 1A-1E, there is illustrated an embodiment of a spinal cage system100. The spinal cage system100may include a cage110, an external plate130, a rod140, and an internal plate150.

As shown inFIGS. 1A-1E, the cage110may include a body portion112with at least one opening114through the cage to, for example, allow for bone fusion between two adjacent vertebral bodies in the spine. The at least one opening114, as shown inFIGS. 1A-1C, extends from a superior surface to an inferior surface of the cage110. It is also contemplated that additional openings114may also extend, for example, from a first side to a second side, from an anterior surface to a superior surface, and/or between any combination of the surfaces of the cage110to enable insertion and placement of bone graft material. The at least one opening114may also include, for example, a plurality of protrusions116along one or more interior surface of the cage110. The plurality of protrusions116may be used, for example, to assist with bone fusion or the positioning of the external plate130by being able to receive the internal plate150. The plurality of protrusions116may also be, for example, a coating or alternatively shaped interior surface structure to assist with bone fusion.

As shown inFIGS. 1A, 1B, and 1D, the cage110may also include an opening118, a first hole120, and a second hole122on the anterior surface of the cage110. The opening118may be sized to receive the rod140. The terms “opening,” “center opening” and “rod opening” may be used interchangeably herein as they refer to the same opening118. The first hole120and the second hole122may be, for example, holes for receiving fasteners, such as bone screws (not shown). The first hole120and the second hole122may be angled with respect to a top surface of the cage110to enable insertion of the fasteners into the vertebral bodies adjacent to the cage110. In the depicted embodiment, the first hole120is angled to allow for insertion of a fastener into a proximal vertebral body and the second hole122is angled to allow for insertion of a fastener into a distal vertebral body, as shown inFIG. 9B. Alternative configurations of the first hole120and the second hole122are also contemplated, including, but not limited to, the first hole120being angled toward the distal vertebral body and the second hole122being angled toward the proximal vertebral body, as well as, both holes120,122being angled in the same direction.

The external plate130may include an opening132, at least two holes134, and a plurality of additional holes136each extending from a top surface to a bottom surface of the external plate130. The opening132may be sized to receive the rod140. The at least two holes134may be, for example, holes for securing the external plate130to a patient's vertebral bodies using, for example, fasteners, such as bone screws. The at least two holes134may be positioned, for example, with one to the right of the opening132and a second to the left of the opening132. In the depicted embodiments ofFIGS. 1A, 1B, and 1D, the at least two holes134are elongated holes providing the surgeon multiple positions for insertion of a fastener into the patient's vertebral bodies to secure the external plate130to the vertebral bodies. For example, as depicted inFIGS. 1A and 1D, the external plate130includes four holes134, two of the holes134are elongated holes and two are sized to correspond to the size of the fastener and are positioned on the outer ends of the external plate130. The holes134may be, for example, straight, angled, or shaped to allow for insertion of a bone fastener at an angle. The external plate130may be secured to the patient's vertebral bodies, for example, to prevent the cage110from backing out of the patient's vertebral bodies.

It is also contemplated that the spinal cage system100may be used with an alternative external plate170, as shown inFIGS. 3A-3D. The external plate170may be similar to external plate130except the at least two holes134will be sized to correspond to the size of the fasteners. Changing the at least two holes134from elongated holes to approximately the size of a fastener provides for only one position for insertion of the fastener through the external plate130into the patient's vertebral bodies. It is also contemplated that the spinal cage system100may be used with other alternative external plates.

Both external plates130,170may also include the plurality of additional holes136which may be sized to receive, for example, fixations pins to hold the external plate130,170in the desired position while it is secured to the patient's bones. Alternatively, the plurality of additional holes136may be holes to provide the surgeon with additional visualization to assist in positioning the external plate130,170on the patient's spine. Further, the external plates130,170may have a length sized based on the surgical procedure being performed and the length may be, for example, approximately the same length as the cage110, longer than the cage110, or smaller than the cage110. External plates130,170which are longer than the cage110may be used, for example, to span multiple levels of a patient's spine.

With continued reference toFIGS. 1A-1E, the rod140may include a first end142and a second end144. The rod140may also include a plurality of grooves146extending from the first end142to the second end144. Alternative embodiments of the rod140are also contemplated including, but not limited to, a smooth rod, a threaded rod, a screw, an alternative grooved embodiment, or a combination of any of these. For example, the rod140may include at least one grooved portion or threaded portion and at least one smooth portion. The rod140may be sized to be received in opening118of the cage110and to allow for the rod to slide in an anterior/posterior direction within the cage110both prior to and after insertion into a patient. The rod140may also be sized to either allow for rotation of the rod140within the opening118of the cage110or to fix the rod140from rotating within the opening118of the cage110. In an alternative embodiment, the opening118may be threaded to receive a threaded rod. In addition, the rod140may be sized to be received in the opening132in the external plate130and the at least one opening154in the internal plate150. The rod140may be made of, for example, a metal material, such as titanium, nickel, or the like, or alternatively a metal alloy, such as nitinol or the like.

The internal plate150, as shown inFIGS. 1A-1E, may include a plurality of extension members152and at least one opening154. As shown inFIGS. 1A-1B, the internal plate150may include, for example, four extension members152and the opening154may be positioned, for example, centered between the four extension members152. The opening154may also include a plurality of protrusions or teeth156extending into the opening154. The plurality of protrusions156may be designed to correspond to the plurality of grooves146of the rod140. The internal plate150is designed to allow for bone fasteners to pass through the cage110and into a patient's surrounding vertebral bodies without engaging the internal plate150. In addition, the internal plate150may be configured to enable at least one extension member152to act as a cutting blade to cut into at least one adjacent vertebral body endplate. If the extension members152are made to engage the surrounding vertebral bodies, then the internal plate150may be used for temporary placement of the spinal cage system100while fasteners are inserted into the cage110and/or the external plate130.

The spinal cage system100may also include at least one locking mechanism160, as shown inFIG. 1C. The locking mechanism160may include, for example, a top member162and a bottom member164, as illustrated inFIGS. 1A-1E. The top member162and the bottom member164may each include an opening166and a plurality of protrusions or teeth168surrounding the opening. The plurality of protrusions168may be positioned to engage the plurality of grooves146in the rod140. In one embodiment, the top member162may be configured to couple directly to the bottom member164. Alternatively, the top member162and bottom member164may be configured to secure a plate, for example, the external plate130, the internal plate150, or the like, to the rod140, as shown inFIGS. 1B-1C. By securing the external plate130and/or internal plate150to the rod140this enables a surgeon to rotate either the external plate130or the rod140to rotate the internal plate150. The locking mechanisms160may be, but are not limited to, for example, washers, grub screws, threaded washers, and the like. In addition, the locking mechanisms160may be made of, for example, a metal material, such as, titanium, nickel, or the like.

As shown inFIGS. 1B-1C, the spinal cage system100may be assembled using, for example, at least one locking mechanism160. In one embodiment, the spinal cage system100may be assembled by inserting the rod140into the opening118in the cage110. Once the rod140is inserted into the cage110, the internal plate150may be secured to the rod140using at least one locking mechanism160by, for example, first sliding the top member162of the locking mechanism160onto the rod140, then sliding the internal plate150onto the rod140, and finally sliding the bottom member164of the locking mechanism160onto the rod140. Next the top member162and bottom member164of the locking mechanism160may be secured together to hold the internal plate150to the rod140. The top member162may be secured to the bottom member164by, for example, press fitting the top member162and the bottom member164together. Other locking mechanisms are also contemplated for securing a plate130,150to a rod140both in fixed position and to enable rotation of the plate130,150relative to the rod140.

The external plate130may also be secured to the rod140using at least one locking mechanism160, as shown inFIG. 1C. The external plate130may be secured by, for example, sliding a bottom member164of the locking mechanism160onto the rod140, then the external plate130may be slid over the rod140, and finally the top member162of the locking mechanism160may be slid over the rod140. Next the top member162and bottom member164may be secured together to attach the external plate130to the rod140. In one embodiment, after securing the external plate130to the rod140, the external plate130may rotate relative to the rod140and in another embodiment rotation of the external plate130will cause rotation of the rod140and vice versa. If the external plate130is secured to the rod140, such that they rotate together, then the internal plate150may also rotate relative to the external plate130when the internal plate150is fixed to the rod140. Thereby, allowing the internal plate150to be positioned such that the bone fasteners may be inserted through the cage110without interfering with the internal plate150.

In addition to rotation of the external plate130, the external plate130may also translate relative to the anterior surface of the cage110. The translation of the external plate130allows for the plate to be secured to the patient's vertebral bodies either flush with the cage110or not flush with the cage110. Thus, the size of the rod140determines the amount of translation that the external plate130may move relative to the cage110. Alternative locking mechanisms160to secure the internal and external plates150,130, respectively, to the rod140are also contemplated. It is also contemplated that the rod140may be secured to the external plate130prior to insertion into the cage110and securing of the internal plate150to the rod.

The external plate230may include an opening232and at least two holes234each extending from a top surface to a bottom surface of the external plate230. The opening232may be sized to receive the rod140. The at least two holes234may be, for example, holes for securing the external plate230to a patient's vertebral bodies using, for example, fasteners, such as bone screws. The at least two holes234may be positioned, for example, with one to a first side of the opening232and a second to a second side of the opening232opposite the first side. In the depicted embodiments ofFIGS. 2A, 2B, and 2E, the at least two holes234include four holes, two to the first side of the opening232and two to the second side of the opening232. Additional configurations for holes234are also contemplated in external plate230as desired by the surgeon for placing bone screws to secure the plate230to the patient's spine. The external plate230may have a length sized based on the surgical procedure being performed and the length may be, for example, approximately the same length as the cage210, longer than the cage210, or smaller than the cage210.

The spinal cage system200may also include at least one locking mechanism160, as shown inFIGS. 2B-2D. The at least one locking mechanism160may be of the type described above with reference to spinal cage system100. The at least one locking mechanism160may be used to assemble the spinal cage system200. For example, the spinal cage system200may be assembled by inserting the rod140into the opening212in the cage210. Once the rod140is inserted into the cage210, the internal plate150may be secured to the rod140using at least one locking mechanism160by, for example, sliding the top member162of the locking mechanism160onto the rod140, then sliding the internal plate150onto the rod140, and finally sliding the bottom member164of the locking mechanism160onto the rod140. Next the top member162and bottom member164of the locking mechanism160may be secured together to hold the internal plate150to the rod140. The top member162may be secured to the bottom member164by, for example, press fitting the top member162and the bottom member164together. Alternative locking mechanisms160are also contemplated. The external plate230may also be secured to the rod140using at least one locking mechanism160. For example, a bottom member164of the locking mechanism160may be slid onto the rod140, then the external plate230may be slid over the rod140, and finally the top member162of the locking mechanism160may be slid over the rod140. Next the top member162and bottom member164may be secured together to attach the external plate230to the rod140. In one embodiment, after securing the external plate230to the rod140, the external plate230may rotate relative to the rod140and in another embodiment rotation of the external plate230will cause rotation of the rod140and vice versa.

Referring now toFIGS. 4A-4E, another spinal cage system300is shown. The spinal cage system300may include the cage210, the external plate130, and the rod140. The cage210may be of the type described above with reference toFIGS. 2A-2Fand the external plate130and the rod140may be of the type described above with reference toFIGS. 1A-1E. The spinal cage system300may also include at least one locking mechanism160, as described above with reference toFIGS. 1A-2F. In the embodiments depicted inFIGS. 4A-4E, there are two locking mechanisms160which include a top member162and a bottom member164.

The spinal cage system300may be assembled prior to insertion into a patient by inserting the rod140through the opening212in the cage210. After the rod is inserted through the opening212and is extending into the at least one opening114in the cage210, a locking mechanism160may be attached to the second end144of the rod140. The locking mechanism160may be attached by inserting a top member162over the second end144of the rod140in the opening114. Next a bottom member164may be inserted over the second end144of the rod140and the top member162and bottom member164may be aligned near the second end144and secured together. When the top member162and bottom member164are secured together to form the locking mechanism160, they also attach the locking mechanism160to the rod140to form a stop member310. Alternatively, if the opening118includes a removable washer216, the spinal cage system300may be assembled after insertion of the cage210into the patient. The washer216may have an opening shaped to match the shape of the rod140and to either allow for the rod140to rotate within the washer opening or fix the rod140in place. For example, the locking mechanism160may be fastened to the rod140to form the stop member310, as described in greater detail above. Then, the stop member310may be inserted through opening118into cage210. The opening212of the washer216may then be aligned with and inserted over the first end142of the rod140and secured into opening118.

Once the stop member310is formed and positioned within the opening114in the cage210, the external plate130may be attached to the rod140with a locking mechanism160. The external plate130may be attached by inserting a bottom member164on the first end142of the rod140, then sliding the external plate130over the rod140, and finally sliding a top member162onto the rod140. Next the top member162and bottom member164may be secured together to attach the external plate130to the rod140. The external plate130may be secured to the rod140so that it may rotate relative to the rod140or the external plate130may be secured to the rod140so that as the external plate130is rotated the rod140will also rotate. The external plate130may be secured to the rod140either before or after the stop member310is secured to the second end144of the rod140.

A spinal cage system400is shown inFIGS. 5A-5E. The spinal cage system400may include the cage210, the external plate230, and the rod140. The cage210and the external plate230may be of the type described above with reference toFIGS. 2A-2Fand the rod140may be of the type described above with reference toFIGS. 1A-1E. The spinal cage system400may also include at least one locking mechanism160, as described above with reference toFIGS. 1A-2F. In the embodiments depicted inFIGS. 5A-5E, there are two locking mechanisms160which include a top member162and a bottom member164.

The spinal cage system400may be assembled by inserting the rod140through the opening212in the cage210. After the rod is inserted through the opening212and is extending into the at least one opening114in the cage210, a locking mechanism160may be attached to the second end144of the rod140. The locking mechanism160may be attached by inserting a top member162over the second end144of the rod140in the opening114. Next a bottom member164may be inserted over the second end144of the rod140and the top member162and bottom member164may be aligned near the second end144and secured together. When the top member162and bottom member164are secured together to form the locking mechanism160, they also attach the locking mechanism160to the rod140to form a stop member410. Alternatively, if the opening118includes a removable washer216, the spinal cage system400may be assembled after insertion of the cage210into the patient. For example, the locking mechanism160may be fastened to the rod140to form the stop member410, as described in greater detail above. Then, the stop member410may be inserted through opening118into cage210. The opening212of the washer216may then be aligned with and inserted over the first end142of the rod140and secured into opening118.

Once the stop member410is formed and positioned within the opening114in the cage210, the external plate230may also be attached to the rod140with a locking mechanism160. The external plate230may be attached by inserting a bottom member164on the first end142of the rod140, then sliding the external plate230over the rod140, and finally sliding a top member162onto the rod140. Next the top member162and bottom member164may be secured together to attach the external plate230to the rod140. The external plate230may be secured to the rod140so that it may rotate relative to the rod140or the external plate230may be secured to the rod140so that as the external plate230is rotated the rod140will also rotate. The external plate230may be secured to the rod140either before or after the stop member410is secured to the second end144of the rod140.

Referring now toFIGS. 6A-6E, a spinal cage system500is shown. The spinal cage system500includes the cage210, an external plate510, and the rod140. The cage210may be of the type described above with reference toFIGS. 2A-2Fand the rod140may be of the type described above with reference toFIGS. 1A-1E. The spinal cage system500may also include at least one locking mechanism160, as described above with reference toFIGS. 1A-2F. In the embodiments depicted inFIGS. 6A-6E, there are two locking mechanisms160which include a top member162and a bottom member164.

The external plate510may include an opening512and a plurality of extensions members514. The opening512may be positioned, for example, in the center of the plurality of extension members514. As shown inFIGS. 6A and 6D, the external plate510may include, for example, four extension members514, although other numbers of extension members514are also contemplated. The extension members514may include, for example, at least one hole along each extension member514to receive a fastener for securing the external plate510to the vertebral bodies. It is also contemplated that at least two of the extension members514may include, for example, at least one hole along each extension member514for receiving fasteners to secure the external plate510to the vertebral bodies. The extension members514may also be used to, for example, prevent fastener or screw back out by aligning over the holes120,122. The external plate510may have a length sized based on the surgical procedure being performed and the length may be, for example, approximately the same length as the cage210, longer than the cage210, or smaller than the cage210.

The spinal cage system500may be assembled by inserting the rod140through the opening212in the cage210. After the rod is inserted through the opening212and is extending into the at least one opening114in the cage210, a locking mechanism160may be attached to the second end144of the rod140. The locking mechanism160may be attached by inserting a top member162over the second end144of the rod140in the opening114. Next a bottom member164may be inserted over the second end144of the rod140and the top member162and bottom member164may be aligned near the second end144and secured together. When the top member162and bottom member164are secured together to form the locking mechanism160, they also attach the locking mechanism160to the rod140to form a stop member520. Alternatively, if the opening118includes a removable washer216, the spinal cage system500may be assembled after insertion of the cage210into the patient. For example, the locking mechanism160may be fastened to the rod140to form the stop member520, as described in greater detail above. Then, the stop member520may be inserted through opening118into cage210. The opening212of the washer216may then be aligned with and inserted over the first end142of the rod140and secured into opening118.

Once the stop member520is formed and positioned within the opening114in the cage210, the external plate510may also be attached to the rod140with a locking mechanism160. The external plate510may be attached by inserting a bottom member164on the first end142of the rod140, then sliding the external plate510over the rod140, and finally sliding a top member162onto the rod140. Next the top member162and bottom member164may be secured together to attach the external plate510to the rod140. The external plate510may be secured to the rod140so that it may rotate relative to the rod140or the external plate510may be secured to the rod140so that as the external plate510is rotated the rod140will also rotate. The external plate510may be secured to the rod140either before or after the stop member520is secured to the second end144of the rod140.

A spinal cage system600is shown inFIGS. 7A-7E. The spinal cage system600includes the cage210, an external plate610, and the rod140. The cage210may be of the type described above with reference toFIGS. 2A-2Fand the rod140may be of the type described above with reference toFIGS. 1A-1E. The spinal cage system600may also include at least one locking mechanism160, as described above with reference toFIGS. 1A-2F. In the embodiments depicted inFIGS. 7A-7E, there are two locking mechanisms160which include a top member162and a bottom member164.

The external plate610may include an opening612and a plurality of extensions members614. The opening612may be positioned, for example, in the center of the plurality of extension members614. As shown inFIGS. 7A and 7D, the external plate610may include, for example, two extension members614, although other numbers of extension members614are also contemplated. The extension members614may include, for example, at least one hole on each extension member614to receive a bone screw for securing the external plate610to the vertebral bodies. The extension members614may also be used to, for example, prevent back out of the fasteners by aligning over the holes120,122. The external plate610may have a length sized based on the surgical procedure being performed and the length may be, for example, approximately the same length as the cage210, longer than the cage210, or smaller than the cage210.

The spinal cage system600may be assembled by inserting the rod140through the opening212in the cage210. After the rod is inserted through the opening212and is extending into the at least one opening114in the cage210, a locking mechanism160may be attached to the second end144of the rod140. The locking mechanism160may be attached by inserting a top member162over the second end144of the rod140in the opening114and inserting a bottom member164over the second end144of the rod140. The top member162and bottom member164may then be aligned near the second end144and secured together. When the top member162and the bottom member164are secured together to form the locking mechanism160, they also attach the locking mechanism160to the rod140to form a stop member620. The external plate610may also be attached to the rod140with a locking mechanism160. The external plate610may be attached by inserting a bottom member164on the first end142of the rod140, then sliding the external plate610over the rod140, and finally sliding a top member162onto the rod140. Next the top member162and bottom member164may be secured together to attach the external plate610to the rod140. The external plate610may be, for example, secured to the rod140so that it may rotate relative to the rod140. Alternatively, the external plate610may be secured to the rod140so that as the external plate610is rotated the rod140also rotates. The external plate610may be secured to the rod140either before or after the stop member620is secured to the second end144of the rod140.

A method of assembling spinal cage systems100,200,300,400,500,600is shown inFIG. 10. The method may include, for example, obtaining the components of a spinal cage system250. The components of the spinal cage system may include, for example, a cage110,210, an external plate130,230,510,610, a rod140, and at least one locking mechanism160. In addition, some spinal cage systems may include an internal plate150. In one embodiment the method may further include inserting an internal plate into the cage260, inserting a rod through the cage to engage the internal plate270, and securing the internal plate to the rod inside the cage280. Alternatively, the method may further include inserting the rod through the cage265, aligning a stop member with the rod275, and securing the stop member to the rod inside the cage285. Both methods may also include attaching an external plate to the portion of the rod extending out of the cage290. The methods of assembling spinal cage systems100,200,300,400,500,600are described in greater detail above.

A method for inserting a spinal cage system100,200,300,400,500,600,800,900is shown inFIG. 11. The method may include making an incision over the patient's spine and preparing the spine for implanting a spinal cage system1000. The method may also include obtaining a spinal cage system1010and assembling the spinal cage system1020. Further, the method may include inserting the spinal cage system into the disk space1030and aligning the cage into a desired position relative to the two adjacent vertebral bodies1040. The method may also include evaluating the position of the spinal cage system1050. If the placement of the spinal cage system and the alignment of the patient's spine are acceptable to the surgeon, then fasteners, such as bone screws, may be inserted through the external plate and the cage1060, in the position shown inFIG. 9A. Alternatively, if the placement of the spinal cage system and/or alignment of the patient's spine is not acceptable to the surgeon, the surgeon may reposition the external plate and/or the internal plate relative to the cage and vertebral bodies1070. The surgeon may reposition the external plate by sliding the plate and rod in an anterior-posterior direction until a desired depth of the external plate is achieved. Then the external plate may be rotated until a desired superior-inferior alignment of the external plate relative to the vertebral bodies is achieved. Once the external plate has reached a desired position, the surgeon may insert fasteners, such as bone screws, through both the cage and the external plate1080. Finally, the patient's incision may be closed1090. The spinal cage systems100,200,300,400,500,600,800, and900may be implanted into a human or an animal.

The method ofFIG. 11may be described in greater detail with reference toFIGS. 9A-9B. As shown inFIGS. 9A-9B, after preparing the patient's spine for insertion of the implant300, the surgeon may slide the cage210into the disk space between two adjacent vertebral bodies102,104. If necessary the surgeon may tamp the cage210into a recessed position in the disk space. When the cage210is inserted into the disk space the external plate130may be attached to the cage210or the external plate130may be attached after the cage210is inserted into the patient. In both methods, the external plate130may either be positioned flush to the cage210or positioned at an extended position away from the cage210. When the cage210is placed in a recessed position relative to the vertebral bodies102,104, the plate130will generally be offset from the cage210to allow the plate130to clear the vertebral bodies102,104when it is rotated relative to the cage210.

If the external plate130is attached to the cage210during the initial implantation it will generally be aligned parallel with the cage210, as shown inFIG. 9A. Once the cage210has been placed at the desired depth, it will be determined if the external plate130needs to be translated in an anterior-posterior direction relative to the cage210. In circumstances where the external plate130does not need to be moved in an anterior-posterior direction, the cage210and external plate130may be secured to the vertebral bodies102,104as illustrated inFIG. 9A. The cage210and external plate130may be secured by inserting fasteners, such as bone screws, not shown, first through the holes134in the external plate130and then through the first and second holes120,122, respectively, in the cage210.

Alternatively, if the external plate130does need to be moved in an anterior-posterior direction, then the external plate130may be translated in an anterior-posterior position with the rod140relative to the cage210until a desired anterior-posterior position of the external plate130has been achieved. Once the desired anterior-posterior position has been achieved, the external plate130may be rotated relative to the cage210to enable the external plate130to be secured to the vertebral bodies102,104. As shown inFIG. 9B, the external plate130can be positioned perpendicular to the cage210, in fact, the external plate130may rotate 360° and be positioned at any desired angle relative to the cage210. Once the desired position of the cage210and the external plate130have been determined, fasteners320, such as bone screws, may be inserted into the first and second holes120,122to secure the cage210to the vertebral bodies102,104. In addition, fasteners322, such as bone screws, may be inserted through holes134in the external plate130to secure the external plate130to the vertebral bodies102,104.

Alternatively, when an internal plate150isn't used and the external plate130is inserted after the cage210, the cage210will be inserted and fixed to the vertebral bodies102,104, then the external plate130may be coupled to the rod140and inserted into the patient to engage the cage210. After the external plate130and the rod140are inserted into the cage210, the external plate130may be translated and rotated to a desired position and secured to the patient's vertebral bodies102,104.

In a further alternative method, the cage210with the rod140may be inserted into the patient. Once the cage210is positioned in a desired position, the rod140may be translated relative to the cage210to position the rod140at a desired position for attachment of the external plate130. Next the external plate130may be attached to the first end of the rod140either in the desired position for attachment to the vertebral bodies102,104or in the position easiest for the surgeon to attach the external plate130and then rotated to the desired position for attachment to the vertebral bodies102,104.

After the cage210and the external plate130have been secured to the vertebral bodies102,104, either together or separately, the surgeon may finish the surgical procedure and close the patient's incision.

The spinal cage systems100,200,300,400,500,600may be assembled, for example, in situ. Thus, enabling a surgeon to insert the spinal cage systems100,200,300,400,500,600by, for example, endoscopic or tubular means with the external plate130,230,510,610aligned with the cage110,210. Then, once the spinal cage system100,200,300,400,500,600is inserted through a small aperture, the surgeon may assemble or adjust the external plate130,230,510,610with respect to the cage110,210in situ.

A cage system700is shown inFIGS. 8A-8I. The cage system700includes, for example, a cage body portion702, a locking member710, and a fastener730. The cage body portion702may include at least one opening704through the cage702to, for example, allow for bone fusion between two adjacent vertebral bodies in the spine. The at least one opening704, as shown inFIG. 8A, extends from a superior surface to an inferior surface of the cage body portion702. It is also contemplated that the at least one opening704may be positioned in an alternative position such that it extends from a first side to a second side of the cage body portion702, an anterior surface to a posterior surface, and/or between any combination of the surfaces of the cage702to allow for insertion of bone graft material into the opening704. The at least one opening704may be of the type described above with reference to the at least one opening114ofFIGS. 1A-1E.

The cage body portion702may also include at least one first hole706and at least one second hole708, as shown inFIGS. 8A-8B.FIG. 8Bshows a cross-section of the first hole706. The first hole706may be angled, for example, toward the proximal surface of the cage body portion702and the second hole708may be angled, for example, toward the distal surface of the cage body portion702. Alternative arrangements for the holes706,708are also contemplated as discussed above in greater detail with respect toFIGS. 1A-1E. The holes706,708may include a first section724and a second section726. The first section724may have a larger diameter than the second section726. In addition, the first section724and the second section726may be threaded.

As shown inFIGS. 8C-8E, the locking member710may include a body or head712with an opening716that extends from a top to a bottom of the body712. The opening716may create an interior surface718. The interior surface718may include a smooth portion720and a grooved portion722. As shown inFIG. 8E, the grooved portion722may be, for example, positioned near the top of the interior surface718, while the smooth portion720may be positioned near the bottom of the interior surface718. The grooved portion722may include a plurality of protrusions or teeth alternating with a plurality of grooves. The locking member710may also, for example, be press fit into the holes706,708of the body portion702. Thus, the cage system700would come preassembled with a locking member710fixed into each of the holes706,708. The locking mechanisms710would be fixed into the first sections724of the holes706,708.

The fastener730, for example, a bone screw, is shown inFIGS. 8F-8G. The fastener730may include a head portion732and a shaft portion738extending away from the head portion732. The head portion732may include an opening734and a plurality of grooves736. The opening734may be positioned in the center of the head portion732to receive an instrument, for example, a drill or screw driver, for inserting the fastener730into the patient's vertebral bodies. The plurality of grooves736may be positioned around the exterior surface of the head portion732and designed to engage the grooved portion722of the locking member710, as shown inFIG. 8I. The shaft portion738may include threads740and a tip742. The threads740may be positioned on at least a portion of the exterior surface of the shaft portion738. As shown inFIGS. 8G-8I, the threads740may, for example, extend from the head portion732to the tip742of the shaft portion738.

As shown inFIGS. 8H-8I, the locking member710and the fastener730together may form a locking screw assembly750. The plurality of grooves736of the fastener730may be positioned under the plurality of grooves of the locking member710to secure the fastener730into the patient's vertebral bodies and prevent back out of the fastener730. Alternatively, the locking member710and fastener730may be coupled by the plurality of grooves736of the head portion732of the fastener730being aligned with the grooved portion722of the locking member710, such that if the fastener730started to back out of the patient's bone the fastener730would engage the grooved portion722of the locking member710and prevent back out of the fastener730. By coupling the locking member710and the fastener730, the fastener730is prevented from turning and thereby prevents the fastener730from backing out of the patient's vertebral bodies. As shown inFIG. 8B, the fastener730is sized to engage and potentially couple to the second section726of the holes706,708and the locking member710is sized to engage and potentially couple to the first section724of the holes706,708. The first and second sections724,726of the holes706,708may each be, for example, threaded to receive corresponding threads of the locking member710and fastener730and the threads may assist with preventing back out of the screw assembly750. The cage system700may be implanted into a human or an animal. It is also contemplated that the locking screw assembly750may be used anywhere a bone fastener or screw is currently used, not only within a patient's spine, but anywhere in a patient's body in order to prevent back out of the fastener or screw from a bone. The locking member710and/or fastener730may also be used with the cages110,210and may be, for example, secured into the holes120,122by, for example, corresponding threads, press fitting, or any other securement method. Further, the locking members710may be inserted into the holes of the external plates, for example, into holes134,234of the external plates130,230, to prevent the fasteners from backing out of the external plates after insertion into the patient's vertebral bodies.

A method of inserting the cage system700is shown inFIG. 12. The method may include, for example, placing an incision over the patient's spine and preparing the spine for implanting a cage system1100. The method may also include obtaining a cage system1110and inserting the cage system into the disk space1120. The method may further include aligning the cage relative to the two adjacent vertebral bodies1130and evaluating the position of the cage system1140. In addition, the method may include inserting fasteners through the cage and into the vertebral bodies1150and inserting at least one locking mechanism into the cage over the fasteners1160. The method may also include activating the at least one locking mechanism to prevent the fasteners from backing out of the cage1170. Finally, the method may include completing the surgical procedure and closing the patient's incision1180.

Alternatively, if the cage system700includes integrated locking members710in holes706,708, then the method for inserting the cage system700may include, for example, placing an incision over the patient's spine and preparing the spine for implanting the cage system700. The method may also include obtaining a cage system700with integrated locking members710and inserting the cage system700into the disk space. The method may further include aligning the cage relative to the two adjacent vertebral bodies and evaluating the position of the cage system700. Further, the method may include inserting fasteners730through the locking members710and the body portion702and into the vertebral bodies. In addition, the method may include misaligning the head portion732of the fastener730with respect to the locking members710to block the fasteners730from backing out of the body portion702.

The cage system700ofFIGS. 8A-8Imay also include an opening (not shown), such as opening118of the cage110, as shown inFIGS. 1A-1B, or opening212of the cage210, as shown inFIGS. 2A-2B, in the body portion702for receiving a rod140as described in greater detail above. Inserting an opening (not shown) in the body portion702enables use of an external plate, for example, external plate130,170,230, with the cage system700. In an embodiment of cage system700including an opening in the body portion702, it may be assembled by obtaining the body portion702including an opening (not shown), inserting a rod140through the opening (not shown), and attaching a stop member, for example, stop member310,410,520, or the like, or an internal plate, for example, internal plate150or the like, to the second end144of the rod140inside the at least one opening704. Next the external plate130,170, or230may be attached to the first end142of the rod140by, for example, a locking mechanism160which enables the external plate130,170, or230to rotate relative to the rod140.

If the cage system700includes an opening in the body portion702for receiving a rod140, then the method as described above with reference toFIG. 12, may also include inserting the rod140into an opening (not shown) in the body portion702and securing a stop member, for example, stop member310,410,520, or the like, or an internal plate, for example, internal plate150or the like, to the second end144of the rod140inside the at least one opening704prior to inserting the body portion702into the patient. An external plate, for example, external plate130,170,230or the like, may be rotatably attached to the rod140at a first end142prior to insertion of the body portion702into the patient. Alternatively, the external plate, for example, external plate130,170,230or the like, may be secured to the rod140at a first end142after the body portion702with the rod140and stop member or internal plate are inserted into the patient between two vertebral bodies. Once the body portion702and the rod140with the attached external cage are positioned between the two vertebral bodies, the surgeon may secure the external plate and body portion702to the vertebral bodies. The body portion702may be secured to the vertebral bodies with the external plate positioned parallel to the longitudinal axis of the body portion702by inserting a fastener through the openings in the external plate and the holes706,708in the body portion702.

Alternatively, the body portion702may be secured to the vertebral bodies with the external plate positioned out of alignment with the longitudinal axis of the body portion702. For example, the external plate may be positioned relatively perpendicular to the longitudinal axis of the body portion702or in any position where the openings in the external plate are not aligned with the holes706,708of the body portion702. The external plate may be positioned to avoid prior instrumentation. This enables the surgeon to insert the body portion702deeper into the vertebral bodies and to adjust the depth of the external plate with respect to the body portion702by pulling the rod140out of the cage the required distance to enable the external plate to align with the surface, for example, anterior surface, of the vertebral bodies. Once the desired position of the body portion702between the vertebral bodies and the external plate with respect to the surface of the vertebral bodies is achieved then the body portion702and external plate may be secured to the vertebral bodies. When the external plate is not aligned with the holes706,708of the body portion702, then the fasteners730may be inserted into the holes706,708to secure the body portion702to the vertebral bodies and locking members710may be inserted into holes706,708to prevent the fasteners730from backing out of the vertebral bodies. The external plate may also be secured to the vertebral bodies using fasteners730and locking members710to prevent the fasteners730from backing out of the vertebral bodies. Alternative methods of inserting locking members710and fasteners730may also be used here as described above in greater detail. Once the locking members710have been activated to prevent the fasteners730from backing out the surgeon may complete the surgical procedure and close the patient's incision.

Another spinal cage system800is shown inFIGS. 13A-13E. The spinal cage system800may include a cage810, the external plate130, a rod840, and a flange member850. The external plate130may be of the type described above with reference toFIGS. 1A-1E, which will not be described again here for brevity sake. The cage810may be similar to the cage110and may include the body portion112, at least one opening114, the plurality of protrusions116, the opening118, and the first and second holes120,122of the cage110, as described in greater detail above with reference toFIGS. 1A-1E. As depicted, the cage810may have, for example, a different inner and outer configuration than the cage110to allow for engagement of the flange member850with the plurality of protrusions116.

The rod840, as shown inFIGS. 13A-13D, may include a first end842and a second end844. The rod140may also include an opening846near the second end844of the rod840for receiving or coupling to the flange member850. Alternative embodiments of the rod140are also contemplated including, but not limited to, a grooved rod, a threaded rod, a screw, or a combination of any of these. For example, the rod840may include at least one smooth portion and at least one threaded or grooved portion. The rod840may be sized to be received in opening118of the cage810and to allow for the rod to slide in an anterior/posterior direction within the cage810both prior to and after insertion into a patient. The rod840may also be sized to either allow for rotation of the rod840within the opening118of the cage810or to fix the rod840from rotating within the opening118of the cage810. In addition, the rod840may be sized to be received in the opening132in the external plate130. The rod840may be made of, for example, a metal material, such as titanium, nickel, or the like, or alternatively a metal alloy, such as nitinol or the like.

Referring now toFIGS. 13A-13E, the flange member850may include a first flange852, a second flange854, and a connecting member856attached at a first end to the first flange852and at a second end to the second flange854. The first flange852may be positioned relatively perpendicular to the connecting member856in a first direction and the second flange854may be positioned relatively perpendicular to the connecting member856in a second direction. The first and second directions may be opposite each other such that the first and second flanges852,854are parallel to each other at the points of attachment to the connecting member856. The connecting member856may be sized to be received within the opening846in the rod840. In one embodiment, the connecting member856may be rotatable within the opening846, while in alternative embodiments, the connecting member856may be fixed within the opening846. To allow for insertion of the flange member850into the opening846in the rod840, the flange member850may be, for example, made of multiple pieces that couple together after insertion of at least a portion of the connecting member856into the opening846. Alternatively, the connection between at least one of the first flange852and the connecting member856and the second flange854and the connecting member856may be hinged to allow for at least one of flanges852,854to be aligned with the connecting member856for insertion through opening846. Once the connecting member856is positioned in the opening846, the at least one flange852,854would be rotated and locked into place perpendicular to the connecting member856.

The spinal cage system800may also include at least one locking mechanism160, as shown inFIGS. 13B-13D. The at least one locking mechanism160may be of the type described above with reference to spinal cage system100. The at least one locking mechanism160may be used to assemble the spinal cage system800. For example, the spinal cage system800may be assembled by obtaining a coupled rod840and flange member850, then rotating the flange member850parallel to the rod840. Next, the end of the rod840with the flange member850may be inserted into the opening118in the cage810, as shown inFIG. 13B. Once the rod840is inserted into the cage810, the flange member850may be rotated to a position perpendicular to the rod840, as shown inFIG. 13C. The flange member850may be rotated once positioned in opening114by, for example, weighting the flanges852,854to allow for the flange member850to rotate once inside the cage810. Alternatively, the rod840may include a channel (not shown) that extends from the first end842to the opening846to enable a surgeon to insert a tool or instrument into the channel to rotate the connecting member856and in turn rotate the flanges852,854either perpendicular to or parallel with the rod840.

The external plate130may be attached to the rod840prior to insertion of the flange member850into the cage810or alternatively after the flange member850is inserted into the cage810. The external plate130may be attached to the rod840using at least one locking mechanism160, as shown inFIGS. 13B-13D. For example, a bottom member164of the locking mechanism160may be slid onto the rod840, then the external plate130may be slid over the rod840, and finally the top member162of the locking mechanism160may be slid over the rod840. Next, the top member162and bottom member164may be secured together to attach the external plate130to the rod840. Once the external plate130is secured to the rod840and the cage810is positioned between the patient's vertebrae, the surgeon may move the external plate130in an anterior-posterior direction until the desired alignment with the adjacent vertebrae is achieved. Then, the surgeon may rotate the external plate130which will in turn rotate the rod840and coupled flange member850. The flanges852,854of the flange member850will rotate and each engage at least one of the plurality of protrusions116on opposite side walls of the cage810, as shown inFIG. 13D. In another embodiment, the plate130may be configured to rotate independently of the rod840, to allow the surgeon to rotate the rod840to secure the flanges852,854each in a protrusion116to maintain the desired anterior-posterior position, while also providing the surgeon additional flexibility for positioning the external plate130on the patient's vertebrae. Once the external plate130and cage810are in the desired position, fasteners (not shown), for example, bone screws, may be inserted into the first and second holes120,122to secure the cage810to the patient's adjacent vertebral bodies. In addition, fasteners (not shown), such as bone screws, may be inserted through the holes134in the external plate130to secure the external plate130to the patient's vertebral bodies.

Another spinal cage system900is shown inFIGS. 14A-14B. The spinal cage system900may include a cage910, the external plate130, and a rod840with a flange member950. The external plate130may be of the type described above with reference toFIGS. 1A-1E, which will not be described again here for brevity sake. The cage910may be similar to the cage810and may include the body portion112, at least one opening114, the plurality of protrusions116, the opening118, and the first and second holes120,122of the cage810, as described in greater detail above with reference toFIGS. 13A-13E. As depicted, the cage910may also include, for example, a first slot912and a second slot914. The slots912,914may engage the opening118and extend from the anterior surface of the cage910through to the opening114. The slots912,914may be sized and shaped to receive the flange member950.

The rod840may also include the flange member950near the second end844of the rod840. The flange member950may be fixed to the rod840in a position perpendicular to the rod840, as shown inFIGS. 14A-14B, or alternatively rotatably connected to the rod840as described in greater detail above. The flange member950may include a first flange952coupled to a first side of the rod840and a second flange954coupled to a second side of the rod840. The first side may be opposite the second side of the rod. The first flange952may be positioned relatively perpendicular to the rod840in a first direction and the second flange954may be positioned relatively perpendicular to the rod840in a second direction. The first and second directions may be opposite each other such that the first and second flanges952,954are parallel to each other at the points of attachment to the rod840and each flange952,954extends in an opposite direction from the other flange952,954. The first and second flanges952,954may be fixed directly to the rod840or attached to the rod with a connecting member, such as connecting member856described in greater detail above with reference toFIGS. 13A-13C.

The rod840may be sized to be received in opening118and the flanges952,954may be sized to be received in the slots912,914, respectively. The opening118and slots912,914allow the rod to slide in an anterior/posterior direction within the cage910both prior to and after insertion into a patient. The rod840may also be sized to either allow for rotation of the rod840within the opening118of the cage910or to fix the rod840from rotating within the opening118of the cage910once the flanges952,954are positioned within the opening114.

The spinal cage system900may also include at least one locking mechanism160, as shown inFIG. 14B. The at least one locking mechanism160may be of the type described above with reference to spinal cage system100. The at least one locking mechanism160may be used to assemble the spinal cage system900. For example, the spinal cage system900may be assembled by obtaining a rod840with the flange member950. Next, the end of the rod840with the flange member950may be inserted into the opening118and slots912,914in the cage910. The external plate130may be attached to the rod840prior to insertion of the flange member950into the cage910or alternatively after the flange member950is inserted into the cage910. The external plate130may be attached to the rod840using at least one locking mechanism160, as shown inFIG. 14B, and described in greater detail above with reference toFIGS. 13B-13D, which will not be described again here for brevity sake. Once the external plate130is secured to the rod840and the cage910is positioned between the patient's vertebral bodies, the surgeon may move the external plate130in an anterior-posterior direction until the desired alignment with the adjacent vertebral bodies is achieved. Then, the surgeon may rotate the external plate130which will in turn rotate the rod840and coupled flange member950. The flanges952,954of the flange member950will rotate and each engage at least one of the plurality of protrusions116on opposite side walls of the cage910. In another embodiment, the plate130may be configured to rotate independent of the rod840, to allow the surgeon to rotate the rod840to secure the flanges952,954each in a protrusion116to maintain the desired anterior-posterior position, while also providing the surgeon additional flexibility for positioning the external plate130on the patient's vertebral bodies. Once the external plate130and cage910are in the desired position, fasteners (not shown), for example, bone screws, may be inserted into the first and second holes120,122to secure the cage910to the patient's adjacent vertebral bodies. In addition, fasteners (not shown), such as bone screws, may be inserted through the holes134in the external plate130to secure the external plate130to the patient's vertebral bodies.

Optionally, a removable washer216could be inserted into the opening118of cages810,910after insertion of the flange member850,950to prevent the flange member850,950from sliding out of the cage810,910prior to coupling the flange member850,950to the plurality of protrusions116of the cage810,910.

The spinal cage systems100,200,300,400,500,600,700,800,900may be used, for example but not limited to, in the cervical, lumbar, and/or thoracic regions of the spine. Further, the spinal cage systems100,200,300,400,500,600,700,800,900may allow for insertion by different approaches for different vectors of the spine. For example, it is contemplated that the spinal cage systems100,200,300,400,500,600,700,800,900may be inserted into a patient's lumbar region or thoracic region from lateral or anterior approaches. In addition, the spinal cage systems100,200,300,400,500,600,700,800,900may each have different shaped cages110,210depending on the surgical procedure being performed and the optimal cage design desired by the surgeon.

As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from the scope of the invention. The cage, external plate, rod, internal plate, locking mechanism, and other components of the device and/or system as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the devices and systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features ofFIGS. 1A-1E,FIGS. 2A-2F,FIGS. 4A-4E,FIGS. 5A-5E,FIGS. 6A-6E,FIGS. 7A-7E,FIGS. 8A-8I,FIGS. 13A-13D, andFIGS. 14A-14Bmay all be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Additionally, as may be recognized by those or ordinary skill in the art based on the teachings herein, the locking mechanism can be of any of numerous types of locking mechanisms that are currently known or that later become known to secure or otherwise couple a plate or stop member to a rod; additionally, more than one locking mechanism could be employed. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the invention.

The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.