The present invention relates generally to orthopedic implants used for correction of spinal injuries or deformities, and more specifically, but not exclusively, to spinal implants, systems, and methods of use and methods of manufacture thereof, for fixing a portion of the spine, such as the cervical spine, to allow correction or healing.
In the field of spinal surgery, it is known to place implants into vertebrae for a number of reasons, including (a) correcting an abnormal curvature of the spine, including a scoliotic curvature, (b) to maintain appropriate spacing and provide support to broken or otherwise injured vertebrae, and (c) perform other therapies on the spinal column.
Some treatments involve the removal of a disk, distraction of the disk space, and the insertion of an interbody device between two adjacent vertebrae. The interbody device, which may include an artificial disk, or a variety of fusion cages or other aids, typically are coupled to one or more of the vertebral bodies. This coupling in some cases involves fixed spikes which engage the end plates of the vertebral bodies. The fixed nature of the spikes usually requires that the disk space be over distracted to provide sufficient clearance for insertion of the interbody device. Further, the fixed spikes can be problematic in the event the interbody device must be removed, or repositioned. Improvements are desired.
The present invention provides spinal implants and systems which may be used for fixing a portion of the spine, such as the cervical spine, to allow correction or healing. The present invention further provides methods of use and methods of manufacture of the implants and systems. In one embodiment, a spinal implant of the present invention includes a body having at least one cavity therein. A barb is disposed within the cavity, with the barb adapted to rotate about a support member between a retracted position and a deployed position. This movement may include rotating the barb from the retracted position to the deployed position, and from the deployed position to the retracted position. In this manner, the barb may be selectively moved between desired positions, including the retracted and deployed positions. For example, the retracted position may be used during insertion, removal, or repositioning of the implant between two vertebral bodies. The deployed barb position may be used for encouraging the barbs to engage the vertebral bodies to provide additional stability, promote fusion between the implant and vertebral bodies, hold the implant relative to the vertebral bodies, and the like.
In some aspects, the barb is rotatably coupled to the support member so that the barb can rotate through a desired range of rotation. The rotation range may include, without limitation, at least about forty-five degrees (45°) of rotation between the retracted and deployed positions, about ninety degrees (90°) of rotation, or other rotational ranges. In some aspects, the support member extends through the cavity to provide an axis of rotation for the barb. The barb may further be positioned within the cavity so that the barb is disposed below a surface of the implant body when the barb is in the retracted position. The barb may have a variety of shapes within the scope of the present invention. In a particular embodiment, the barb includes a barb body having a rounded outer edge and a pointed end. The barb may, but need not be, substantially C-shaped. In other embodiments, the barb includes a tapered tip, which may be shaped as a blade, a pyramid, an angled edge, or the like.
In some aspects, the spinal implant includes a deployment device adapted to engage the barb within the body to cause the barb to rotate into the deployed position. The deployment device may have a variety of shapes and configurations within the scope of the present invention. For example, in one aspect the deployment device includes a rod that is received by a channel within the body, with the channel in communication with the cavity. In alternative aspects, the deployment device is removably coupled to the body to hold the barb in the deployed position; is disposed within the body to be generally orthogonal to the support member; and/or is positioned so that its removal from the body allows the barb to rotate from the deployed position towards the retracted position.
In some embodiments, the spinal implant includes a plurality of barbs and a plurality of cavities. In some aspects, each barb resides in a separate cavity. In a particular aspect, the barbs are adapted to rotate in a same direction when engaged by the deployment member or members. The barb axis of rotation may be below the surface of the implant body, and the barbs may each have separate support members, or some or all barbs may share one or more support members. In other aspects, the body includes an opening passing at least part way therethrough, with the opening adapted to receive a spinal implant placement instrument, a fixation element for coupling the body to the vertebral body, or the like.
In a particular embodiment of the present invention, a spinal implant includes a first body having a barb disposed within an aperture and adapted to rotate about a support member, a second body, and a nucleus member disposed between the first and second bodies. In this embodiment, the spinal implant may operate as an artificial disc, with the first and second bodies positioned adjacent, abutting or coupled to two opposing vertebral bodies. In some aspects, the nucleus is adapted to allow relative movement, such as relative rotational motion, between the first and second implant bodies.
The present invention further provides methods of using a spinal implant. In one embodiment, the method includes providing a spinal implant as described herein, inserting the implant between two vertebral bodies, and rotating the barb about the support member to cause the barb to engage one of the vertebral bodies. In one aspect, rotation of the barb includes inserting a deployment device into the spinal implant first body. The deployment device engages a barb body to rotate the barb from a retracted position to a deployed position. In one aspect, the method includes fixing the barb in the deployed position by coupling the deployment device to the spinal implant first body.
In one particular embodiment, the method includes retracting the spinal implant, with the retraction causing or helping cause the barb to rotate about the support member. For example, retracting the spinal implant may cause the barb to rotate from a deployed position to a retracted position. The retraction may include applying a translational force to the implant body, with the translational force applying a rotational force to the barb. In this manner, the retraction force on the implant helps cause or causes the barb to rotate out of the vertebral body and towards the retracted position.
Other features and advantages of the invention will appear from the following description in which the preferred embodiment has been set forth in detail in conjunction with the accompanying drawings.
Reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of embodiments of the invention as illustrated therein, being contemplated as would normally occur to one skilled in the art to which the invention relates.
Turning to
In a particular embodiment, barb 130 is rotatably coupled to body 110, and in some embodiments, is rotatably coupled to a support member 140 within cavity 120. In this embodiment, barb 130 has an axis of rotation that is below first surface 112. Barb 130 axis of rotation may coincide with support member 140. This occurs, in one embodiment, when support member 140 passes through a hole 134 in a body portion 132 of barb 130. In a preferred embodiment, barb 130 rotates freely about support member 140. In this embodiment, support member 140 is inserted into a support member channel 142, and locked in place at or near a support member end 144. Support member 140 may be locked or otherwise coupled to body 110 using a weld, an adhesive, a mechanical lock, or another mechanism or technique. With support member 140 coupled to body 110, barb 130 may be rotated about support member 140.
In other embodiments, barb 130 is rotatably coupled to the inside of cavity 120. This may occur, for example, by providing barb body 132 with extensions, prongs, or the like (not shown), that engage a detent, gap, hole or the like in opposing walls of cavity 120. In one embodiment, the barb body extensions are integrally formed with barb body 132 so that barb body 132 does not need hole 134. In this embodiment, the extensions fit into the opposing detents, cavities, gaps, holes, or the like within cavity 120 walls so that the extensions rotate freely therein. In this manner, barb body 132 can rotate within cavity 120 to permit barb 132 to move between retracted and deployed positions. Other devices and methods for rotatably coupling barb 130 to implant body 110 also fall within the scope of the present invention.
In one embodiment, barb(s) 130 are adapted to rotate between a deployed position and a retracted position. Barbs 130 are depicted in a deployed position in
In one embodiment, deployment member 150 is an elongate member having a shaped distal end 152 which is inserted into implant body 110. The elongate deployment member 150 may have a cross sectional shape which coincides with the shape of channel 160. The depicted embodiment shows generally cylindrical elongate deployment members having a circular cross section received by similar shaped channels 160. In other embodiments, deployment member 150 may have elliptical, square, rectangular or other cross sectional shapes. Shaped end 152 is adapted to engage barb 130 to rotate barb 130 from the retracted position to the deployed position. In a particular embodiment, shaped end 152 is angled, pointed, conical, chamfered, or the like to engage barb 130, and more particularly, to engage barb body 132 as best seen in
In some embodiments, deployment member 150 has a lock mechanism 156 disposed at or adapted to be coupled to the deployment member 150 proximal end. Lock mechanism 156 may comprise a variety of mechanisms or techniques to couple deployment mechanism 150 to barb body 110, including without limitation a screw, a pin with a C-clip, a pin with a cap, a cam lock, and the like. In a particular embodiment, deployment member 150 includes a threaded proximal end 154 which engages with a threaded opening 162 of channel 160 to secure deployment member 150 to implant body 110. Threaded proximal end 154 may include a locking device, such as a cap, C-clip, set screw, or the like, to prevent or help prevent deployment member 150 from backing out of channel 160.
In one embodiment, spinal implant 100 includes one or more extensions or flanges 172 extending from body 110. Extensions 172 may be used, for example, to engage a posterior or anterior surface of the vertebral body to which spinal implant 100 is coupled. In some embodiments, extension 172 has an opening 170. Opening 170 may extend at least part way through extension 172. In this manner, opening 172 can be a tool-engaging recess, adapted to receive a spinal implant placement or revision instrument. The instrument, for example, may engage opening 172 to hold spinal implant body 110 during surgery. In another embodiment, opening 170 passes completely through extension 172. In this embodiment, opening 170 is adapted to receive a spinal implant placement or revision instrument, or to receive a fixation element for coupling body 110 to a vertebral body. The fixation element may comprise a wide range of devices, including vertebral bone screws or the like. The size, shape and number of extensions 172, and openings 170 therein, may vary within the scope of the present invention compared to that depicted in the Figures.
With reference to
In the event spinal implant 100 is to be removed or repositioned, it may be desirable to have barbs 130 disengage from vertebral body 200. In a particular embodiment of the present invention, deployment member 150 is partially or fully removed from implant body 110 to permit barbs 130 to return to the retracted position. The removal of deployment member 150, in some embodiments, occurs prior to or contemporaneously with the removal of implant 100. In a preferred embodiment, barbs 130 are permitted to rotationally move from the deployed position to the retracted position. Barbs 130, in some cases, may rotate to the retracted position after removal of deployment member 150. This may occur, for example, in the event spinal implant 100 has been recently implanted, too recent for substantial bony growth which may engage implant 100 and/or barbs 130.
In other embodiments, as shown in
It will be appreciated by those skilled in the art that implant 100 depicted in
In the embodiment of
In one embodiment, nucleus portion 650 is integrally formed with or comprises part of first member 610 and/or second member 620. For example, first and second members 610, 620 may form a ball and trough arrangement similar to that disclosed in U.S. Pat. No. 6,113,637, entitled “Artificial Intervertebral Joint Permitting Translational and Rotational Motion,” the complete disclosure of which is incorporated herein by reference. First member 610 may define the ball and second member 620 may define the trough, or vice versa. In this manner, interfacing surfaces of first and second members 610, 620 provide the means for articulation of implant 600. Further, in some embodiments, barbs 630 may be used instead of or in addition to screw fixation to help couple implant 600 to one or more vertebral bodies. First and second members 610, 620 may also define a ball and socket, or other configuration, with the interface of the two members providing for relative movement therebetween. Other means for articulation between members 610, 620 also fall within the scope of the present invention.
Components of the described embodiments may be made from a variety of materials compatible for use with the human body, including without limitation metals (e.g., titanium, nitinol, stainless steel), ceramics, polyethylene, PEEK, and other materials.
Having described several embodiments, it will be recognized by those skilled in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Accordingly, the above description should not be taken as limiting of the scope of the present invention.