INTERVERTEBRAL DISC IMPLANT
Systems and tools for inserting and securing an implant within the intervertebral space. An intervertebral disc implant with upper and lower bearing members with an articulation interface between the members for providing relative motion therebetween. The implant may be provided with various securing members for fixing the implant within the intervertebral space. A tool may be used to insert the implant, which includes a plurality of shiftable implant engaging members that are shiftable between non-engaging and engaging configurations to alternatively release or hold the implant.
This application is a continuation of U.S. patent application Ser. No. 15/639,416, filed Jun. 30, 2017, which is a continuation of U.S. patent application Ser. No. 14/991,191, filed Jan. 8, 2016, now U.S. Pat. No. 9,693,872, which is a continuation of U.S. patent application Ser. No. 14/270,076, filed May 5, 2014, now U.S. Pat. No. 9,233,011, which is a continuation of U.S. patent application Ser. No. 12/541,658, filed Aug. 14, 2009, now U.S. Pat. No. 8,715,350, which claims the benefit of U.S. Provisional Patent Application No. 61/089,283, filed Aug. 15, 2008. U.S. patent application Ser. No. 12/541,658 is a continuation-in-part of U.S. patent application Ser. No. 11/856,667, filed Sep. 17, 2007, now U.S. Pat. No. 8,597,357, which claims the benefit of U.S. Provisional Patent Application No. 60/825,865, filed Sep. 15, 2006, and U.S. Provisional Patent Application No. 60/912,138, filed Apr. 16, 2007. Each of the aforementioned applications are incorporated herein by reference in their entirety.
FIELD OF THE INVENTIONThe invention relates to apparatuses for securing an implant within a joint and, more particularly, to apparatuses for securing an implant in the intervertebral space.
BACKGROUND OF THE INVENTIONJoint degeneration is a common problem that can occur in a variety of joints throughout the human body. The condition typically is more prevalent as the skeletal system ages and is often treated with medications and/or physical therapy. These conservative treatments sometimes meet only limited success. If unsuccessful, the patient typically will continue to experience ongoing pain and limited mobility.
Often the treatment progression leads to a total joint replacement. These replacements have been performed for years in joints such as the hip and the knee. The replacement devices usually comprise some form of a metallic structural component or endplate with an intermediate polyethylene core. It is not unusual for replacements such as these to give 15-20 years of service before requiring some degree of revision.
In the spine, the surgical treatment of choice has been fusion for the treatment of intervertebral disc degeneration. The spinal intervertebral disc is arguably the most important joint in the spine and is situated between the vertebral bodies. The spinal disc is comprised of a tough outer ring called the annulus, and a jelly-like filling called the nucleus. The belief has been that removing the diseased spinal disc(s) and fusing between affected levels will not make a significant difference in the overall mobility of the spine. However, spinal fusion has proved to cause an increase in degeneration at other vertebral levels that must compensate for the loss of motion at the fused level commonly causing the patient to relapse into more pain and limited mobility.
Recently, there has been a focus on the use of “motion preservation” implants over implants that promote spinal fusion. These motion preserving implants, in the form of joint replacements in the spine, hope to alleviate many of the problems associated with fusion devices in the spine. Intervertebral disc replacement devices are seen today typically comprising a pair of biocompatible metal plates with a polymer or elastomeric core, or a metal plate articulating on a metal plate.
Metal on metal implants have a history of failure in long term use, however, precision machining has spawned a reemergence of implants using these materials since it is believed that this change in manufacturing greatly improves the wear. Regardless, the metal implants are radiopaque and continue to frustrate surgeons due to the difficulty in imaging the affected area. Other implants, such as those using a polymer or elastomeric core between metallic plates suffer from the same radiopaque frustrations due to the metal components in addition to the added complexities of design due to the necessity of utilizing a multitude of materials for a single implant.
The prior art discloses a laundry list of biocompatible materials including metals, ceramics, and polymers, that can be used for the manufacture of these implants, yet historically many of these materials have failed when interfaced together and tested in an articulating joint. There is in particular an extensive history of failure when polymers articulate against polymers in weight bearing artificial joints. Due to this failure history, polymer combinations have naturally been excluded as an acceptable self-articulating material combination for use in weight bearing joint replacements.
PEEK (poly-ether-ether-ketone), for example, has been suggested as an appropriate material of manufacture for use in implant devices due in large part to its strength, radiolucent nature, and biocompatibility. This is particularly true in structural implants having no articulating component. PEEK on PEEK has been suggested for use in low wear non-weight bearing joints such as in finger joints. However, the prior art has been careful not to suggest self-articulating PEEK on PEEK as a suitable material combination in weight bearing joint replacement devices due to the failure history of biocompatible polymers articulating against themselves.
One important consideration in the design of an implant is ensuring that the implant remains at the implant site, and does not migrate. Migration of the implant away from the intended implant site can cause dangerous and even fatal complications. In the case of an intervertebral implant, the close proximity of vital blood vessels, nerves, the spinal cord, and other vital tissues makes securing the implant in place a vital concern. Many different ways to secure the implant to the adjacent bone of the joint have been proposed, including implementing protrusions or spikes, keels, screws, surface roughening, and bone-growth inducing coatings.
In one known form disclosed in Published U.S. Patent Application 2007/0270961, a spinal implant is provided with deployable and retractable barbs for securing the implant to a vertebra. In one embodiment, the barbs 130 have arcuate bodies having sharpened tips for protruding into the vertebral bone. The barbs 130 are disposed within recesses 120 in the implant body 110 and rotatably mounted on pins 140. The pins 140 are disposed transversely to channel 160, such that the barb rotates about the pin along the longitudinal axis of the channel. The barbs 130 are deployed via interaction with a rod 150 that is inserted into the channel 160 of the implant body 110. The rod 150 has a sloped end for engaging the barbs 130 and causing them to rotate upwards about the pins 140 and into engagement with the bone.
In another form according to U.S. Patent Application 2007/0270961 shown in FIG. 5A-5D of that application, the deployable barbs take the form of conical spikes 530 configured to be deployed into the adjacent vertebra for securing the implant thereto. The spikes 530 have lower edges 538 which engage with the tapered tip 552 of the rod 550, which propels the spikes through apertures 520 in the implant body 500. The implant is also supplied with a lock mechanism 548 in the form of annular washers that prevent the barb 530 from exiting the implant body 510.
One embodiment shown in FIG. 6 of U.S. Patent Application 2007/0270961 is described as having a nucleus portion 650 that may comprise a ball and trough arrangement to permit translational and rotational motion therebetween. However, the figures of the application do not disclose such a nucleus portion, and it is believed that the implants shown and described therein would be unable to incorporate such a configuration. Specifically, the implant bodies do not have sufficient material thickness to incorporate at least a trough portion for a ball and trough configuration.
In addition, in the configurations of the embodiments shown in 1A-4D of U.S. Patent Application 2007/0270961, the implant would be drawn further into the intervertebral space by the deployment of the barbs due to their shape and their axis of rotation about the pins. This pulling effect is believed to be counteracted by the protrusions 172 disposed on the end of the implant, such that an inner surface of the protrusions can bias against a surface of the adjacent vertebra, thereby preventing the implant from being pulled further into the intervertebral space. However, implants that have protrusions that extend outside of the intervertebral space are less preferred. For example, a cervical implant that protrudes from the intervertebral space between adjacent vertebrae may come into contact with the trachea, which can cause pain or difficulty in swallowing.
SUMMARY OF THE INVENTIONTesting in our laboratories however, told a different and unexpected story. In simulated weight bearing artificial joint configurations, PEEK against PEEK performed very favorably. PEEK articulating against PEEK demonstrated exceptional mechanical performance and biocompatibility characteristics required for load bearing artificial joints used in the human body and in other animals. PEEK may also be manufactured in a fiber reinforced form, typically carbon fiber, which also performs favorably against itself and against non-fiber reinforced PEEK.
Once PEEK was recognized as a viable option for self-articulation, it became clear that an entire articulating joint could be made from the material without the need for metallic structural or articulating components. This discovery substantially simplified the nature of weight bearing artificial joint replacement design and great benefits have emerged. A partial list of these benefits include artificial joints that; have less components due to integrating features into the same component that were previously separated due to the need for a plurality of materials to serve the function, will last longer due to favorable wear characteristics, are substantially radiolucent, have a modulus of elasticity closer to the bone tissue they are implanted in, and are ultimately less expensive. It is important to note that less components typically equates to fewer modes of failure, reduced inventory, and simplified manufacturing and assembly. Although less preferred, clearly one may choose to keep the metallic components of an implant system and utilize PEEK on each articulating surface of the artificial joint for a PEEK on PEEK articulation.
Two piece articulating PEEK on PEEK intervertebral implants have been presented in earlier applications by the same inventor. These implants perform exceptionally well for replacement of the spinal nucleus. However, many indications require implants of this nature to also comprise improved restraining features particularly in weight bearing applications.
For example, there is a need for a simplified radiolucent artificial disc device, with excellent wear characteristics and features that will secure the device to the vertebral endplates or otherwise restrain it between the vertebral bodies. An artificial disc such as this would be particularly useful as a lumbar disc replacement, and even more so as a cervical disc replacement. The cervical disc is much smaller than the lumbar disc as is the space the cervical disc occupies. For at least this reason, a simplified design utilizing fewer parts is beneficial.
The articulating joint surfaces are preferably a combination of PEEK articulating on PEEK, PEEK on carbon reinforced (CR) PEEK, or CR PEEK on CR PEEK. Boney integration of these implants may benefit from prepared osteo-conductive surfaces or coatings described elsewhere in this document.
It is preferable that the radiolucent implant includes one or more small radiopaque markers which will show on up an X-ray image to assist the surgeon in positioning the implant during surgery. The preferred material for these markers is tantalum. Typically these markers will be encased in predetermined locations in the implant at their periphery. Coatings which show up on imaging as a subtle outline of the implant device may also be used.
It is also preferable that the implants disclosed herein include a layer of osteo-conductive or osteo-inductive surfaces or coatings on those implant surfaces in contact with bone or tissue that will assist in securing the implant in a predetermined location. Typically this will occur through boney integration of the bone with the coating or implant surface. Examples of such coatings are hydroxyapatite, calcium phosphates such as tricalcium phosphate, or porous titanium spray.
The implant devices disclosed herein are particularly suited as intervertebral disc replacements for all or a portion of the natural intervertebral disc. In addition, the securing members disclosed herein are also suited for other spinal implants, such as vertebral body replacements, spinal cages, and other fusion promoting implants, as well as other known motion preserving implants. The devices have minimal structural parts and are preferably manufactured from specialized materials that are substantially radiolucent such as PEEK or Carbon-Fiber PEEK in both their structural and joint articulating portions.
Generally, the various systems and methods described herein allow for an implant, such as an artificial disc, to be properly sized, implanted and secured in an intervertebral space with the disc having a bearing interface that preserves motion between the upper and lower vertebrae between which the disc is implanted and secured. In each form described herein, a trial spacer may be used to assess the size of the intervertebral space so that an appropriately sized disc implant can be selected, and may also be used to assist in generating features in the vertebrae and/or end plates thereof for a securing member that holds and retains the disc implant in the intervertebral space.
An insertion tool may be used for inserting the implant within the intervertebral space between adjacent vertebrae. The insertion tool is generally comprised of a handle portion, an actuator, and a gripping mechanism. The gripping mechanism may include a plurality of shiftable implant engaging members for engaging with the implant. The implant engaging members may be shiftable prongs located at a distal end of the tool that are configured to shift between a non-engaging and engaging configurations to alternately release and hold the implant, respectively. The prongs preferably shift vertically, i.e., either inferiorly or superiorly when moving between the non-engaging and engaging configurations. The tool engages with the implant at tool engaging portions of the implant, such as a tool receiving recess formed in the inner facing surface of each of the upper and lower bearing members. The tool may include additional features such as tab members for engaging with tool engaging portions on the implant bearing members to grip the bearing members between the shiftable prongs and the tab members.
In some forms, the securing mechanism is associated with the implant to be inserted into the intervertebral space therewith. After the disc and securing mechanism are inserted in the intervertebral space, the securing mechanism can be deployed into the preformed features in the adjacent vertebral bodies from the disc implant. In one form, the insertion tool is used to engage the securing mechanism with the preformed features in the intervertebral bodies. In another form, the securing mechanism is actuated directly to engage the securing mechanism with the preformed features of the vertebral bodies.
In yet another form, the securing mechanism is inserted into the intervertebral space via the trial spacer prior to insertion of the disc implant. In this form, the securing mechanism is actuated directly to be deployed into the features in the adjacent vertebral bodies with the disc implant then inserted into the intervertebral space. Thereafter, the securing mechanism is actuated so as to engage both the implant and the vertebral body for securing the implant in the intervertebral space.
In any event, the level of restraint required for a particular orthopedic application will vary. This disclosure also describes examples of a variety of securing mechanisms or alternative features suitable for restraining the device in a predetermined location. The securing mechanisms generally possess structure which allow for dynamic fixation of the implant. Instead of relying solely on subsidence or boney ingrowth of the bone around the features of the implant, the securing mechanisms actively engage the bone for immediate and reliable fixation of the implant to the vertebrae. In one embodiment, a rotatable shaft with at least one bone engaging body is disposed on the implant for securing the implant within the intervertebral space. In an undeployed position, the bone engaging body is disposed within the implant body. When the shaft is rotated, the bone engaging body is deployed into the vertebra and thereby fixes the implant to the vertebra to prevent migration of the implant.
In addition, securing mechanisms according to the present invention may incorporate designs that transmit tactile feedback to the surgeon when the securing mechanism is being operated. As it is very difficult for the surgeon to visually ascertain the position of the implant and its securing features during operation, a surgeon will also use his hands to feel for tactile responses transmitted from the implant and through his tools. In one embodiment, the securing mechanism has a cammed surface for interacting with a corresponding cammed surface to cause the securing mechanism to be biased against the implant to provide resistance against the movement of the securing mechanism that can be felt through the surgeon's tools. In this manner, the surgeon can easily ascertain when the securing mechanism has been fully extended or deployed. The tactile feedback features of the securing mechanism also prevent the securing mechanism from being over- or under-actuated, i.e. deploying the securing mechanism beyond its intended range of motion, or failing to fully deploy the securing mechanism. This condition may result in improper fixation of the implant and cause damage to the implant, spine, nerves, vascular system, or other tissue in the area around the spine.
Another aspect of the current invention includes securing mechanisms for an implant having anti-retraction or derotation prevention means. Some securing mechanisms according to the present invention are deployed or extended into the bone by actuating the securing mechanism, for example, by rotating a shaft. However, it is possible for the securing mechanism to retract or derotate back to its undeployed position over time, due to forces exerted on the implant. Thus, to prevent such an event, a securing mechanism may be provided with means to prevent retraction or derotation. In one embodiment, derotation prevention means are provided in the form of a camming surface on the securing mechanism in combination with a corresponding camming surface on the implant. The camming surfaces are disposed to engage or interfere with one another when the securing mechanism is in a fully deployed position to prevent derotation of the securing mechanism.
In some forms, the securing member is associated with the implant to be inserted into the intervertebral space therewith. After the disc and securing member are inserted in the intervertebral space, the securing member can be deployed into the adjacent vertebral bodies from the disc implant. In one form, the insertion tool is used to engage the securing member with the intervertebral bodies. In another form, the securing member is actuated directly to engage the securing member with the vertebral bodies.
The securing members generally possess structure which allow for dynamic fixation of the implant. Instead of relying solely on subsidence or boney ingrowth of the bone around the features of the implant, the securing members actively engage the bone for immediate and reliable fixation of the implant to the vertebrae. In one embodiment, a rotatable shaft with at least one bone engaging body is disposed on the implant for securing the implant within the intervertebral space. In an undeployed position, the bone engaging body is disposed within the implant body. When the shaft is rotated, the bone engaging body is deployed into the vertebra and thereby fixes the implant to the vertebra to prevent migration of the implant.
In some forms, the securing member is disposed on the upper and lower surfaces of the upper and lower faces of the implant. However, in other forms, the securing member may be completely submerged within the body of the implant such that the upper and lower surfaces with the implant are relatively smooth or flat. When the securing member is securely submerged within the implant, the upper and lower vertebrae need not be prepared prior to the insertion of the implant, thereby simplifying the implantation procedure.
In another form, an implant according to the present invention may be provided with upper and lower bearing members having respective bodies and outer bearing surfaces. An articulation interface disposed between the upper and lower bearing members allows for relative movement therebetween. A securing member is disposed on one of the bearing members and has an elongate shaft portion and a bone-engaging member disposed on the shaft portion. The bone-engaging member is movable from an undeployed position, wherein the bone-engaging member is positioned out of engagement with an adjacent bone, and a deployed position, wherein the bone-engaging member is positioned in engagement with the adjacent bone via rotational displacement of the shaft portion. In some forms, the securing member is entirely disposed within the body of the bearing member when in an undeployed position.
In other forms, the securing member may include at least one bone engaging body disposed on the implant which is deployed into the vertebrae by the insertion of an elongate member into the implant body. The bone engaging body is disposed on the implant such that insertion of the elongate member causes the bone engaging body to be deployed from its initial position to a bone engaging position. Once the elongate member is inserted into the implant body, the bone engaging body is fully deployed and the elongate body is left within the implant to hold the bone engaging body in the deployed position.
The securing member in some forms includes an elongate shaft portion disposed within a channel of the bearing member and may have a plurality of bone engaging members. The bone engaging members may be lobe members having bodies orientated generally transversely to the elongate shaft portion. The lobe members may have a sharpened portion for easing insertion of the lobe member into the vertebral bone by either cutting or piercing the bone. In other forms, the lobe members may be sized and configured for engaging with prepared surfaces of the vertebra, wherein the surfaces are prepared prior to the insertion of the implant. The vertebra may be prepared using a cutting tool to form a securing member receiving portion by removing bone at the implant site. The bone may be prepared by cutting grooves or channels sized and configured to receive the securing member.
The securing member may be connected to the body of the bearing member via a retainer member for connecting the securing member to the bearing member body. In one form, the retainer securing member has opposing arms spaced from each other for receiving the elongate shaft member between the opposing arms by a friction fit.
The upper and lower bearing members may be sized and configured to fit entirely between inner surfaces of adjacent vertebrae when the deployable securing member is in an undeployed configuration. This configuration eases insertion of the implant, because the vertebrae need not be prepared prior to insertion. Moreover, in a preferred form, the implant fits entirely within the footprint of the intervertebral disc space such that the implant does not interfere with adjacent blood vessels, nerves, tissues, digestive or respiratory tracts and the like.
In another form according to the present invention, an intervertebral disc implant has a deployable securing member disposed on the implant body with a projection of the deployable securing member movably connected to the body having a head portion with an edge for engaging a bone, an actuation portion of the securing member having an actuator engagement portion thereon. The projection is deployable between an undeployed position, wherein the projection is remote from an adjacent vertebra, to a deployed position, wherein the projection is engaged with the adjacent vertebra through the interaction of the actuator with the projection when the actuator is inserted along an insertion axis into the body. The head portion of the deployable securing member is oriented in a generally transverse orientation with respect to the insertion axis when the securing member is in a deployed position.
The implant body has an outer bone engaging surface for non-invasive contact with an inner surface of the adjacent vertebra and a securing member mating portion of the implant body for mating with the securing member which protrudes outwardly beyond the bone engaging surface. The securing member mating portion comprises an elongate opening for receiving the projection and allowing the projection to travel from the undeployed position, wherein the projection is disposed within the opening, to a deployed position, wherein the projection protrudes from the opening and is brought into engagement with the adjacent vertebra. The implant body may be part of a unitary implant, such as a spacer implant, or the implant body may be one member of a multiple-part implant, such as one of upper and lower bearing members. In a multi-part implant, the upper and lower bearing members may be provided with upper and lower inner arcuate bearing surfaces that slidingly engage one another. The sliding interface between the upper and lower bearing members between the upper and lower inner arcuate bearing surfaces allows the bearing members to articulate with respect to one another. In one form, the upper and lower inner arcuate bearing surfaces are sized and configured to allow the upper and lower bearing members to rotate with respect to one another over a range of approximately 13.7-22.5 degrees in flexion and 13.8-30 degrees in extension, depending on implant size.
In one form, the edge of the projection is deployed rostrally or caudally into engagement with the adjacent vertebra without substantial translation in another direction. For example, the projection may be a spade-like lobe that is driven straight up into the vertebral bone when it is actuated by an actuator. In other forms, the projection is connected to a pivot shaft connected to the implant body and oriented generally parallel to the insertion axis such that the projection pivots along with the shaft in a direction transverse to the insertion axis during deployment of the projection. Preferably, the projection and pivot shaft rotate about a pivot shaft axis parallel to the insertion axis during deployment of the projection.
In yet another form, the securing member may take the form of a bendable elongate member that may be inserted into a securing member receiving portion of the upper or lower face of the implant. The bendable elongate member is inserted into the securing member receiving portion which causes the bendable elongate member to flex or bend causing a projection to protrude into the adjacent vertebrae thereby fixing the implant to the vertebrae. The bendable elongate member may include preformed protrusions that are deployed upon compression of the elongate member.
The implant preferably includes an implant body having a securing member receiving portion. A bendable securing member for being inserted into the securing member receiving portion is provided to secure the implant to the vertebra. The bendable securing member is inserted into an opening of the securing member receiving portion to deploy a bone engaging member of the bendable securing member. The bone engaging member is movable from an undeployed orientation, wherein the bone engaging member is remote from an adjacent vertebra, and a deployed orientation, wherein the bone engaging member is brought into contact with the adjacent vertebra for securing the implant body to the adjacent vertebra. In some forms, the bone engaging member is deployed through the plastic deformation of the securing member upon insertion of the securing member into the opening of the securing member receiving portion. An abutment surface of the implant body is provided for engaging with the securing member to facilitate deformation of the securing member by compression of the securing member against the abutment surface. The bone engaging member may be a barb member disposed on the bendable securing member. In a preferred form, the barb member is disposed flush to an outer surface of the securing member prior to deployment of the barb. The bone engaging member may have a structurally weakened portion to promote plastic deformation thereof at a predetermined position to deploy the bone engaging member at a desired location. The bendable member preferably comprises a plurality of bone engaging members.
In some forms, the securing member receiving portion has an opening on an outer facing surface of the implant body which permits the bone engaging member to pass through the opening and engage the adjacent vertebra. The bone engaging member is preferably predisposed to bending at locations thereon that correspond to an opening or openings in the outer facing surface of the implant body.
To understand the present invention, it will now be described by way of example, with reference to the accompanying drawings in which:
In a preferred embodiment, such as illustrated in
The convex portion 130 comprises a convex articulation surface 131, and the concave portion 120 comprises a concave articulation surface 121. It is preferred that the articulation surfaces 121 and 131 have substantially matching geometries or radiuses of curvature although some mismatch of curvature may be desired to provide a combination of rolling and sliding motion to occur between the articulation surfaces 120 and 121. The geometries may be complex in nature but preferably are ball and socket style. The convex portion 130 and concave portion 120 may extend substantially to the outer perimeter of the shell 100, 110 as illustrated in
The artificial disc device 001 preferably comprises one or more restraint portion(s) 220 or structure located on one or both of the shell members 100, 110 to help prevent the shells 100, 110 from becoming dislodged or migrating across the boney endplate 141 of the vertebrae 143 after insertion. For example, the restraining portion 220 may be located on one of the shells 100, 110 on the endplate facing surface 142 in the form of directional teeth 140.
It is preferred that the footprint of the artificial disc device 001 be similar to the footprint of the endplate although generally smaller to fit within the intervertebral space. The endplate facing surfaces 142 are preferably contoured to match the contour of the endplates 141. For example, if the surgeon prepares the endplates to be flat, it is preferred that the endplate facing surfaces 142 are also flat. Likewise, if the endplates 141 are prepared to be concave, it is preferred that the endplate facing surfaces 142 are similarly convex. It should be noted that endplates 141 that are concave will generally retain the artificial disc device 001 better since the device 001 becomes cupped between the vertebrae.
Additional restraining features may be needed to assist holding the artificial disc device 001 in the predetermined position. Described in this application are various securing mechanisms, coatings, or surface preparations that can be used on the endplate facing surfaces 142 to restrain an implant.
An additional embodiment of a restraint is illustrated in the artificial disc device 001 shown in
Upon insertion of the artificial disc device 001, the restraint boss 200 acts as a stop to the shell 100, 110 as it is guided to the predetermined position. The boss 200 also assures the device is unable to migrate posteriorly towards the spinal cord and cause injury. It is preferred the recess 002 is generally the thickness of the boss 200 such that the boss 200 may be generally flush with the anterior surface of the vertebral body 144.
The shell 100, 110 preferably includes an attachment portion 210 which may be in the form of a boss, hole, post, recess, ridge, flange or other structure for securing of an implant insertion or removal instrument to assist with inserting or removing the implant from the intervertebral space. For example, in the embodiment in
As described earlier, the restraint portion 220 on the endplate facing surfaces 142 may be in the form of directional teeth 140 which are angled like saw teeth to encourage eased insertion across the boney endplate 141 and resist anterior migration to help retain the shell members 100, 110 in the predetermined location between the intervertebral bodies. The actual form of the restraint portion 220, i.e. directional teeth 140 or a surface coating, may be found on one or both shell 100, 110 members. The restraint portion 220 may include different forms of restraint on each shell 100, 110. In addition, more than one form of restraint may be used on each restraining portion 220. For example, the shell 100 may include a restraint portion 220 which comprises both directional teeth 140 with an osteo-conductive surface coating such as hydroxyapatite.
The shell 100, 110 may include apertures for the placement of fasteners such as bone screws to secure the shell 100, 110 to the endplate 141 after insertion. It is preferable that the fasteners are also manufactured from a radiolucent material such as PEEK, however the surgeon may choose to use fasters made of a biocompatible metal such as from the family of titaniums or stainless steels. It is preferable that these apertures are counter bored when possible to reduce the profile of the screw head outside the periphery of the shell 100, 110. If the device is equipped with a restraint boss 200, the anterior facing surface of this boss is a preferred location for these apertures 520 wherein the apertures 520 are preferably directed towards the center of the vertebral body.
In some forms, the restraint boss 200 may be offset to the left or the right as illustrated in
In other forms, the restraint boss 200 may not be integral to the shell 100, 110. Instead the boss 200 may be configured as a small plate, fastened to the anterior surface of the vertebral body and extending just past the endplate to block back-out of the shell 100, 110 and lateral movement of the shell 100, 110 if the boss 200 is so equipped with interlocking geometry. Further, the disc device may be blocked from backing out by a broad flexible mesh, preferably made of a polymer such as PEEK, fastened from the anterior surface of one vertebral body to the other.
In an alternative embodiment, the artificial disc device 001 shown in
The endplate facing surface 142 comprises a restraint recess 350 to accommodate the paddle 300 and the restraint arm 330 during implant insertion. Once the disc device 001 is inserted, the restraint arm 330 may be deployed into the endplate to secure the device 001 in the desired location between the vertebrae. Several of the disclosed embodiments may require the surgeon to prepare the vertebral body 144 to accept restraint portions 220 that are intended to become integrated into the bone. In most cases, this preparation involves removing bone and creating restraint access 420 typically in the form of a recess, channel, slot or profile similar to the restraint feature. Obviously, the size of the restraint portion 220 will affect the size of the restraint access 420. Therefore it is beneficial that restraint portions 220 that interfere with the bone are suitably sized to prevent an oversized restraint access 420 that compromises the vertebrae 143 and risks vertebrae 143 fracture. It is preferable that both the restraint access 420 and restraint portion 220 have radiused edges to reduce stress concentrations in the vertebral body.
In another alternative embodiment, such as shown in
In an alternative embodiment, the artificial disc device 001 as illustrated in
An additional alternative embodiment of the artificial disc device 001 is illustrated in
Another embodiment of an artificial disc device 001 is illustrated in
In an alternative embodiment, a shell 100, 110 is illustrated in
Similarly, and in a further alternative embodiment, an artificial disc device 001 is illustrated primarily in
Another alternative embodiment is illustrated in
The artificial disc device 001 can take a form of a non-constrained articulating joint wherein the device 001 has no built in features to limit motion between the articulation surfaces 121 and 131. In some cases, this can be problematic if the anatomy of the user, by hard or soft tissue, does not perform this function since it is possible that a shell 100, 110 can dislocate off the other shell 100, 110 and potentially become jammed. In addition, excessive unnatural motion at the device 001 may cause injury to the user. For these reasons it may be advantageous to limit the motion occurring between the articulation surfaces 121 and 131.
The artificial disc device may include a motion-limiting portion. In the shell 110 embodiment shown in
The motion limit portion may take numerous forms. For example, one of the shells 100, 110 may comprise a limiter holder 1120 to house a limit post 1130. Alternatively the limit post 1130 may be integrated into the articulating surface of the shell 100, 110. The limit post 1130 extends into a limit recess 1110 preferably bound by a limit wall 1140. As the shells 100, 110 articulate against each other, interference between the limit post 1130 and the limit wall 1140 limit the motion that can occur between the shells 100 and 110. Clearly, by adjusting the shape and/or size of the limit recess 1110, motion can be limited in varying amounts in different directions. For example, motion can be limited to 10 degrees of flexion but only 5 degrees of lateral bending at the joint.
The artificial disc device 001 may be configured for use when all or a portion of the vertebral body 144 is removed such as in a corpectomy surgery. As seen in
Preferably, both the upper and lower disc members 1312 and 1314 are formed of a PEEK (polyetheretherketone) material which has been found to provide the disc implant 1310 with excellent strength and wear characteristics that are desirable for a joint that is intended for motion preservation such as the artificial disc implants described herein.
Referring to
The forward trial spacer portion 1328 is connected to an enlarged rear portion 1342 that remains outside the intervertebral space 1330 after the trial spacer portion 1328 is fully inserted therein, as shown in
The hollow portion of the tongue 1328 contains a pair of plates 1344 and 1346 with the upper plate 1344 including several upstanding posts 1348 and the lower plate 1346 including several depending posts 1350 corresponding in positioning to the posts 1348, as can be seen in
Referring to
The corresponding platform portions 1352 and 1358 of the plates 1344 and 1346 cooperate to form a wedge-shape elongate openings or channels 1367 and 1369 by way of their facing inclined surfaces 1364 and 1366. More specifically, the corresponding wall portions 1356 and 1362 and the inclined surfaces 1364 and 1366 cooperate to form wedge-shaped side channels 1367 and 1369 which are used to drive the plates 1344 and 1346 apart for creating the indentations or pocket openings in the vertebral bodies, as described further hereinafter.
Referring to
The spreader device 1368 has an enlarged rear, box-shaped portion 1386 that fits in the hollow space defined by a box-shaped portion 1342 of the trial spacer assembly 1326. The spreader device 1368 also includes forwardly projecting arms 1388 and 1390 laterally spaced so that the wedge device 1370 fits therebetween, as can be seen in
Accordingly, to drive the plates 1344 and 1346 apart, the spreader device 1368 and wedge device 1370 are moved in opposite directions with the wedge device 1370 being advanced forwardly so that the inclined surfaces 1392 and 1394 cam against the corresponding plate inclined surfaces 1364 and 1366 to drive the upper plate 1344 in an upward direction toward the vertebral body 1332 and the lower plate 1346 downwardly toward the vertebral body 1334. The rear portion 1386 of the spreader device 1368 has a window opening 1396 to allow the closing device 1370 to fit therethrough so that as the spreader device 1368 is advanced, the wedge device 1370 can be retracted off of the ramp portions 1354 and 1360 of the plates 1344 and 1346 and through the window opening 1396 to allow the plates 1344 and 1346 to be spread apart. In addition, the trial spacer portion 1328 is provided with through openings 1398 so that the posts 1348 and 1350 can be driven therethrough and into the facing surfaces of the vertebral bodies 1332 and 1334. As can be seen in
To remove the trial spacer portion 1328 from the intervertebral space 1330, the trial spacer assembly 1326 is shifted back from its spread or expanded configuration to its insertion/removal or compact configuration with the plates 1344 and 1346 held together with the closing device 1370. For this purpose, the operation of the spreader device 1368 and the closing device 1370 is reversed with the closing device 1370 being advanced forwardly through the window opening 1396 of the spreader device 1368 and the spreader device 1368 being retracted rearwardly until the plate ends 1382 and 1384 are brought together as shown in
After the trial spacer assembly 1326 is utilized as described above to form openings or indentations 1398 in the facing surfaces of the vertebral bodies 1332 and 1334, the implant 1310 is inserted into the intervertebral space 1330 via inserter tool 1400. The inserter tool 1400 has an elongate shaft 1402 and an enlarged head 1404 at its end in which it carries the disc implant 1310 for insertion thereof. Shaft 1402 and the head 1404 are formed by an upper elongate tool member 1406 and a lower elongate tool member 1408 having shaft portions 1410 and 1412, respectively, and an associated head portion 1414 and 1416 at their respective ends. The upper and lower tool members 1406 and 1408 are able to slidingly reciprocate relative to each other for removal of the disc 1310 from the intervertebral space 1330, as will be described more fully hereinafter.
As shown in
As shown in
Referring to
More specifically, the upper and lower tool members 1406 and 1408 preferably include respective, laterally extending stop members 1450 and 1452 that are spaced slightly rearwardly of the rear ends of the slots 1424 an 1426. The tool 1400 is advanced forwardly to fit the tool head 1404 and artificial disc 1310 carried thereby into the intervertebral space 1330. The tool 1404 continues to be advanced forwardly until the stops 1450 and 1452 abut against the vertebral bodies 1332 and 1334 to provide the user an indication that the tool head 1404 and the artificial disc 1310 carried thereby are fully received in the intervertebral space 1330. With the stops 1450 and 1452 engaged against the respective vertebral bodies 1332 and 1334, the posts 1428 and 1430 are now properly aligned with the pocket openings 1398 formed in each of the vertebral bodies 1332 and 1334.
As previously mentioned, the tool members 1406 and 1408 are slidable relative to each other so that one of the members 1406 and 1408 can be retracted while the other member 1406 or 1408 remains in its advanced position with the corresponding stop 1450 or 1452 engaged against the corresponding vertebral body 1332 or 1334. As shown in
In the next trial spacer and disc implantation and securing system, a trial spacer assembly 1450 as shown in
The trial spacer assembly 1450 has a forward, trial spacer portion 1454 that has an outer, peripheral configuration substantially matching that of the disc implant 1452 less the securing mechanism thereof. The trial spacer assembly 1450 also includes a rearwardly extending shaft portion 1456. The trial spacer assembly 1450 is formed from two components. As shown in
The second component of the trial spacer assembly 1450 is a head cover and handle member 1472. The member 1472 includes a head cover portion 1474 that consists of a laterally extending, rear flange portion 1474 from which a central lower prong 1476 and a pair of upper prongs 1478 extend forwardly. Shaft handle portion 1480 extends rearwardly from the flange portion 1474 and has a hollow throughbore 1482 extending therethrough opening to the flange portion 1474, as seen in
The trial spacer assembly 1450 is assembled by sliding the head cover and handle member 1472 over the trial spacer member 158 with the shaft portion 1462 fitting into the throughbore 1482 and the prongs 1476 and 1478 fitting into the corresponding grooves 1466-1470 of the trial spacer head portion 1460. Referring to
At this point, the trial spacer member 1458 is used in cooperation with a drill guide 1488 for drilling grooves in the vertebral bodies 1332 and 1334 at the facing surfaces thereof. Referring to
Next, a cam cutter 1502 is advanced through the bores 1492 and 1494 in a manner similar to the drill bit 1496. The cam cutter 1502 has a reduced size, radially offset cutting end 1504 including several cutting blade portions 1506, and a counter bore cutting portion 1508 at the rear thereof. An enlarged shaft 1510 extends rearwardly from adjacent to the counter bore cutting portion 1508. The shaft 1510 is sized to fit into the openings through the drill guide 1488 formed in cooperation with the trial spacer member 1458, as previously described with respect to the drill bit 1496.
Referring to
More specifically, the cam shafts 1516 and 1522 each include several cam lobe members 1530 spaced along the length thereof and a proximate disc indicator member 1532 adjacent drive head 1534. Initially, the cam shafts 1516 and 1520 are oriented 1480 degrees from their orientation shown in
The next trial spacer and artificial disc implantation and securing system is similar to the previous system except that the securing mechanism is not associated with the artificial disc as it is inserted into the intervertebral space 1330, but rather is first inserted into the preformed features formed in the vertebral bodies 1332 and 1334 and thereafter deployed therefrom to interconnect the vertebral bodies and the artificial disc implant 1552 (
As shown in
Next, cam shafts 1567 are inserted into the intervertebral space 1330 guided by the grooves 1556 and 1558 of the trial spacer member 1554, and then they are rotated and cammed up into the offset grooves 1569 formed in the upper vertebral body 1332 and down into the offset groove 1569 formed in the lower vertebral body 1334, as shown in
In
With the cam shafts 1567 rotated as shown in
In another form, a trial spacer system 1600 is shown in
The trial spacer assembly 1750 generally has a forward trial spacer portion 1754 for insertion into the intervertebral space 1330 and rearward drill guide 1788 integrated with the forward trial spacer portion 1754. The forward trial spacer portion 1754 varies little from the previously described embodiment in
The drill guide portion 1788 of the of the trial spacer assembly 1750 is similar from the drill guide 1488 of
Now referring to
Each drill bit 1796 has a collar 1926 for providing an abutment surface to restrict the distance the bit 1796 may be inserted into the trial spacer assembly 1750. The collar 1926 is an enlarged portion of the drill bit shaft 1928 and abuts the rear face 1914 of the trial spacer assembly 1750 when the drill bit 1796 is fully inserted. This keeps the surgeon from unintentionally drilling too far and damaging surrounding tissue, bone, nerves, and other vital areas.
As shown in
Now referring
Specifically, the head portion 1956 of the trigger link 1950 directly engages the yoke 1958 to move it within the yoke housing 1948 to actuate the gripping mechanism. The yoke 1958 is a cylindrical body having a bore 1960 for accepting the head portion 1956 of the trigger link 1950 and is directly propelled thereby. The yoke 1958 is attached to the push rod 1962 at the rear portion of the yoke's forward end. A spring 1964 disposed between the yoke 1958 and the internal end wall of the yoke housing 1948 provides a biased resistance to the trigger 1938 when the yoke 1958 is actuated by the trigger link 1950.
The yoke housing 1948 is connected to the barrel 1922, which defines an internal bore 1960 for guiding the push rod 1962 through the barrel 1922. The push rod 1962 is preferably made of a flexible material, such as Nitinol. The push rod 1962 extends through the internal bore 1960 within the barrel 1922 from the yoke 1958 to the gripping mechanism 1912. The gripping mechanism 1912 includes a wedge shaped plunger 1966 connected to the push rod 1962 and an expandable flared end 1968. The flared end 1968 has a plurality of flexible tabs 1970 each having a protrusion 1972 at the forward end of the tab 1970 for engaging the recessed portion 1910 within the lower throughbore 1794 of the trial spacer assembly 1750 as shown in
The barrel 1922 includes an insertion guide 1976 disposed on the barrel 1922 near the gripping mechanism 1912 for abutting the rear face 1914 of the drill guide portion 1788 to prevent inserting the barrel 1922 too far into the lower throughbore 1794. In addition, the insertion guide 1976 comprises a guide pin 1920 as described above for engaging the recesses 1916, 1918 in the rear face 1914 of the drill guide portion 1788 to increase maneuverability and stability of the trial spacer assembly 1750.
A solid cylindrical end cap 1978 at the rear end of the tool 1902 is connected to the yoke housing 1948 to provide a contact surface for the surgeon to strike during insertion of the trial spacer assembly 1750.
In operation, the gripping mechanism 1912 is inserted into the lower throughbore 1794 of the trial spacer assembly 1750 with the trigger 1938 depressed to push the plunger 1966 forward to disengage the flexible tabs 1970 of the gripping mechanism 1912. Once the inserter end is fully inserted into the trial spacer assembly 1750, the trigger 1938 is released, causing the plunger 1966 to be pulled back and splaying the flexible tabs radially outward. The flexible tabs 1970 are forced into gripping engagement with the internal surfaces of the lower throughbore 1794, and the guiding pin 1920 engages one of the recesses 1916, 1918 in the rear face 1914 of the drill guide portion 1788 for providing additional stability and control. The trial spacer 1750 is then inserted into the intervertebral space 1330. If the spacer 1750 is the appropriate size, the surgeon will then prepare the vertebrae 1332, 1334 for the implant 1752. While continuing to hold the trial spacer assembly 1750 in place with the trial spacer inserter 1902, the first drill bit 1930 is affixed to the drill, and then inserted into one of the upper throughbores 1792 of the trial spacer assembly 1750. The first groove 1798 is drilled. While the drill bit 1930 is still fully within the trial spacer assembly 1750, the drill bit 1930 is released from the drill and left in place. Next, the second intermediate drill bit 1932 is attached to the drill and the second upper groove 1798 is then drilled. Again, the second drill bit 1932 is left in place. The inserter 1902 is then removed from the trial spacer assembly 1750. This is done by pulling the trigger 1938 to disengage the gripping mechanism 1912 and pulling the inserter 1902 away. The inserter tool 1902 is then removed and the lower groove 1800 is drilled, using the third and longest drill bit 1934. Once all of the grooves have been drilled, all three of the drill bits 1930-34 are removed by hand. In a preferred embodiment, the cam cutting step described in
The artificial disc implant 1752 of the present embodiment varies in only a few respects compared with the artificial disc implant shown in
The securing mechanism may take many forms. In one embodiment according to
This frictional interaction between the camming surfaces 1980, 1982 and a biasing force exerted by the retainer members 1824 on the cam shaft 1816 caused by the deformation of the retainer members 1824 provides tactile feedback to the surgeon. The deformation of the retainer members is preferably elastic, such that the retainer members 1824 will return to their original shape when the cam shaft 1816 is in its fully deployed position. Alternatively, the deformation could be plastic, wherein the retainer members 1824 undergo some irreversible deformation. This is acceptable when the securing mechanism is not deployed and retracted repeatedly.
Once the cam shaft 1816 is turned a full 180 degrees, the cam shaft camming surface 1980 snaps into a recess 1984 formed in the adjacent retainer member 1824, due to the biasing force exerted on the cam shaft 1816 by the flexed retainer members 1824. The recess 1984 and cam shaft camming surface 1980 is formed such that the camming surface 1980 becomes trapped in the recess 1984 and blocks derotation of the cam shaft 1816. More specifically, the cam projection 1979 has a straight, trailing edge surface 1983 that is turned toward the straight edge surface 1985 of recess 1984. Once the trailing edge surface 1983 clears the recess surface 1985, the cam surface 1980 will have traveled past the corresponding camming surface 1982 so that the cam surfaces 1980 and 1982 are disengaged from one another. This removes the axial biasing force that their camming engagement generates, so that the cam projection 1979 travels or snaps axially back into the recess 1984. In this orientation, the flat edge surfaces are in confronting relation to each other so that the cam projection 1979 cannot be moved back out of the recess 1984.
Now referring to
More specifically, the cam projection 1987 has a straight, trailing edge surface 1989 that is turned toward the straight edge surface 1991 of recess 1990. Once the trailing edge surface 1989 clears the recess surface 1991, the cam surface 1986 will have traveled past the corresponding camming surface 1988 so that the cam surfaces 1986 and 1988 are disengaged from one another. This removes the vertical biasing force that their camming engagement generates, so that the cam projection 1987 travels or snaps axially down into the recess 1990. In this orientation, the straight edge surfaces 1989, 1991 are in confronting relation to each other so that the cam projection 1987 cannot be moved back out of the recess 1990.
In another form shown in
The cam shafts 1816, cam members, lobes, or fins 1846 may take on different geometries and orientations to improve performance of the securing mechanism. For example, the camming fins may include serrations 2002, as shown in
Cam members 1846 that cut or imbed themselves into the bone provide advantages over other securing mechanisms. For instance, securing mechanisms that use static projections such as spikes and keels may rely on the subsidence of the bone around the securing mechanism to secure the implant. Static securing mechanisms are less desirable because they may not properly secure the implant to the bone until the bone begins to subside around the securing mechanism. Thus, the implant may tend to migrate prior to bone subsidence. However, dynamic securing mechanisms like cam members 1846 with cutting surfaces 1848 actively cut into or imbed themselves into the bone, instead of relying on the subsidence of the bone. In this manner, dynamic securing mechanisms create a much more reliable and stable connection between the implant 1752 and the vertebra 1332, 1334. These benefits translate into a more robust and reliable implant 1752, which means quicker recovery times and increased mobility for the patient.
In another form, the cam shafts 1816 on the upper disc implant member 1818 may be disposed at converging or diverging angles, such as shown in
It should be noted that the cam shafts 1816 provide certain advantages over other securing mechanisms, such as screws. For instance, screws do not provide a significant level of tactile feedback. It is very difficult for a surgeon to determine how far a screw has been turned, and therefore he may over- or under-rotate the screw, increasing the risk of implant migration and failure. In addition, metal screws may damage the implant if over-tightened. If the implant is made of a relatively soft material, such as PEEK, the metal screws will easily strip and damage the implant if over-tightened. Moreover, a surgeon is more likely to over-tighten a screw housed within a polymer because the screw is so much harder than the polymer that he will not be able to feel when the screw has been over-tightened. To alleviate this problem, the implant 1752 may be fabricated with a metal portion for housing the screw combined with a polymer, but this greatly increases the difficulty in manufacturing the implant 1752, as well as its cost, and is therefore less desirable. In addition, over-rotation of a screw may advance the screw beyond its intended range of motion, and may cause it to protrude from the implant and cause damage to vital areas in and around the spine. Because the cams do not advance or retreat as they are rotated, there is no danger that the cams 1846 will be accidentally projected into other vital areas.
The disc implant 1752 according to the present embodiment has docking features for attaching with the implant insertion tool 2008, as shown in
An insertion tool 2008 according to the present invention is shown in
The gripping mechanism 2020 includes two upper and two lower flexible prongs 2050, 2052 which operate in tandem with upper and lower tabs 2064, 2066 for gripping and holding the disc implant 1752 (shown in
In operation, the implant inserter tool prongs 2050, 2052 are movable in vertical and longitudinal directions to engage and disengage the disc implant 1752. In the initial disengaged position shown in
Once the implant 1752 is secured to the inserter 2008, the disc implant 1752 is then inserted into the intervertebral space 1330. The position of the implant 1752 may be determined using fluoroscopy to view the orientation of the implant 1752. Tantalum markers disposed in the frontal face of both the upper and lower disc members 1818, 1822 allow the surgeon to identify the position of the insertion end of the implant 1752. In addition, the cam shafts 1816, which are also radiopaque when made out of titanium or stainless steel, may be used to determine the orientation of the implant 1752. After the surgeon has placed the implant 1752 in the desired position, he releases the implant 1752 by lifting the lever 2018. The prongs 2050, 2052 are pushed forward and retracted vertically inwards, which releases the implant 1752. The surgeon then secures the implant 1752 in place by actuating the securing mechanism. Specifically, the surgeon turns each of the cams 1816 180 degrees using a driver, thereby deploying the cam members 1846 into the bone of the upper and lower vertebrae 1332, 1334. The surgeon can feel the resistance provided by the interaction between the camming surfaces of the cam shafts 1816 and the retainer member 1824 while deploying the cam members 1846. In this manner, he can determine when the cam members 1846 have been fully deployed. In addition, the camming surfaces of the cam shafts 1816 and the retainer members 1824 will prevent the cams 1816 from derotating and allowing the implant 1752 to migrate.
In a preferred embodiment, such as illustrated in
In the form shown in
The securing member 3006 in the present form has restraint portions in the form of deployable bone engaging members 3006a. The bone engaging members 3006a are disposed on an elongate shaft 3006b housed within the body of the bearing member 3008. In a preferred orientation, the securing member 3006 is secured within a recess 3008b of the body of the bearing member 3008 by a securing member receiving portion 3008a in the form of a snap joint. A neck portion 3006d of the elongate shaft 3006b is held by opposing inner surfaces 3008c of the receiving portion 3008a via an interference or friction fit. In this regard, the preferred PEEK material from which the bearing members including the receiving portion 3008a thereof are formed provides the receiving portion 3008a with sufficient strength and resiliency to provide a secure friction fit with the shaft portions 3006b snap-fit therebetween while allowing for the shaft portions 3006b to be rotated to secure the bearing member 3008 to the corresponding adjacent vertebrae. This configuration is advantageous, because it requires no additional fasteners, pins, or supports, thereby reducing parts and increasing reliability and safety of the implant.
The elongate shaft 3006b is preferably configured with a profile suitable for rotation. The elongate shaft is 3006b provided with a drive head 3006c operable to mate with an actuator, such as a driver, operable to deploy the restraint portions via rotation of the elongate shaft 3006b. The securing member receiving portion 3008a includes an actuator receiving portion 3008e for receiving the actuator therein. In the form illustrated in
The bone engaging members 3006a take the form of lobe members that may be deployed into engagement with the endplate of the vertebrae upon rotation of a drive head 3006c of the elongate shaft 3006b using the proper instrument. The lobe members 3006a have bodies oriented generally transversely to a longitudinal axis of the elongate shaft 3006b. In this orientation, the lobe members 3006a keep the implant from migrating, particularly in the direction along the longitudinal axis. The lobe members 3006a may include a sharpened edge for easing the deployment of the lobe members 3006a into the adjacent bone. The lobe members 3006a may include apertures or slots to encourage bone growth therethrough. In addition, the lobe members 3006a may take a variety of sizes and shapes. Additional examples of securing members may be found in U.S. patent application Ser. No. 11/856,667, filed Sep. 17, 2007, which is incorporated herein in its entirety. Further, although the securing member 3006 is shown having three lobe members 3006a, different numbers of bone engaging members may be implemented. The securing member may be manufactured from an array of biocompatible materials, including, but not limited to polymers such as PEEK or metals such as titanium or stainless steel alloys, although radiolucent materials are preferred.
More specifically, the securing member 3006 includes several lobe members 3006a spaced along the length thereof. Initially, in an undeployed configuration, the securing member 3006 is oriented with the lobe members 3006a oriented downwards or towards the interior of the implant, as shown in
Once the disc device is inserted, the restraining portions may be deployed into the endplate to secure the artificial disc device in the desired location between the vertebrae. In the embodiment shown in
In the embodiments shown in
The deployable securing member 3006, including the deployable bone engaging members 3006a may take on different geometries and orientations to improve performance of the securing member 3006. For example, the lobe members 3006a may include serrations, divots, or recesses to promote boney ingrowth. The serrations may also help to cut the bone when the securing member 3006 is rotated. In addition, the lobe members 3006a may be cupped or slanted to further promote anchoring of the implant to the vertebrae. Further, the lobe members 3006a may have an outside contour, such that shape or size of the lobe members 3006a varies from one end of the shaft 3006b to the other. The contour may match the profile of the endplates to take advantage of the softer bone in the center of the vertebrae as opposed to the harder-denser bone at the periphery of the vertebrae. Further, the shafts 3006b may have any number of lobe members 3006a. In a preferred embodiment, each shaft 3006b may have between three and five lobe members 3006a. Larger implants may have five members per shaft 3006b, while smaller implants may have only three. The shafts 3006b are preferably made from titanium or stainless steel, and may be coated with a bone-growth promoting substance, such as hydroxyapatite, tricalcium phosphates, or calcium phosphates.
In other forms, the shaft(s) 3006b on the upper or lower bearing members may be disposed at converging or diverging angles. This orientation prevents migration of the implant not only in an anterior/posterior direction, but also substantially in the lateral direction as well.
The securing members 3006 of the embodiment described in
In another form in accordance with the present invention, an intervertebral implant 3102 with a deployable securing member 3106 is shown in
The securing member 3106 of
The deployable plate members 3106a are each received in the securing member receiving portion 3108a in restraint portion recesses in the form of generally rectangular openings 3108c (
In operation, once the vertebrae have been prepared (if at all) to accept the implant 3102, the implant 3102 is inserted into the intervertebral space using an insertion tool. The deployable securing member 3106 is actuated by inserting the elongate plunger 3112 into the cylindrical recess 3108g of the actuator receiving portion 3108d, as shown in
The lateral orientation (i.e., transverse to the anterior-posterior axis) of the plate members 3106a is advantageous for providing superior resistance to migration in the anterior or posterior direction of the implant. However, the plate members 3106a may be oriented in other configurations.
The following description of the general features of a preferred embodiment of an intervertebral implant according to the present invention is described with respect to the embodiment in
It is preferred that the footprint of the artificial disc devices herein be similar to the footprint of the endplate although generally smaller to fit within the intervertebral space. The outer bearing surfaces 3108f are preferably contoured to match the contour of the endplates. For example, if the surgeon prepares the endplates to be flat, it is preferred that the outer bearing surfaces 3108f, 3110a are also flat. Likewise, if the endplates are prepared to be concave, it is preferred that the outer bearing surfaces 3108f, 3110a are similarly convex. It should be noted that endplates that are concave will generally retain the artificial disc device better since the device becomes cupped between the vertebrae.
The convex portion 3110b comprises a convex articulation surface 3110c, and the concave portion 3108i comprises a concave articulation surface 3108j. It is preferred that the articulation surfaces 3110c and 3108j have substantially matching geometries or radii of curvature although some mismatch of curvature may be desired to provide a combination of rolling and sliding motion to occur between the articulation surfaces 3110c and 3108j. U.S. Provisional Application 61/050,612 filed May 5, 2008 discloses a “ball-in-bowl” configuration for the articulation surfaces, and is hereby incorporated by reference in its entirety. In particular, the concave articulation surface 3108j may have two different radii of curvature, such that one portion of the concave articulation surface 3108j has a first radius of curvature, and a second portion of the concave articulation surface 3108j has a second, larger radius of curvature. The first radius of curvature is preferably the same as the radius of curvature of the convex articulation surface 3110c, such that rotational sliding may occur between the articulation surfaces 3108j, 3110c. When the joint is extended, the concave articulation surface 3108j is allowed to translate slightly due to the mismatch in curvature between the first radius of curvature of the convex articulation surface 3110c and the second, larger radius of curvature of the concave articulation surface 3108j. This configuration allows for a greater range of motion and a more natural movement of the joint.
As discussed above, the geometries may be complex in nature but preferably are ball and socket style. The convex portion 3110b and concave portion 3108i may extend substantially to the outer perimeter of the bearing member 3108, 3110 as illustrated in
The disc implant 3102 according to the present embodiment has docking features for attaching the implant 3102 to an insertion tool. The lower bearing member 3110 has a shelf-like platform 3110d along its anterior face for providing a contact surface for the implant insertion tool. Similarly, the upper bearing member 3108 has a shelf 3108k on its anterior face for providing a contact surface for the insertion tool. The internal facing surfaces 3108p, 3110f of both bearing members 3108, 3110 each have a pair of generally rectangular recesses 3108m, 3110e disposed thereon to accept gripping members of the insertion tool. Two of the gripping members, prongs 3116, are shown with the implant 3102 for reference. The prongs 3116 engage the upper bearing member 3108 within recesses 3108m during insertion of the implant 3102. Preferably, two additional prongs are provided with the insertion tool for engaging with recesses 3110e to work in tandem with prongs 3116. These docking features are advantageous because the insertion tool manipulates the implant 3102 substantially within the overall footprint of the implant 3102. This prevents trauma to the surrounding tissue and bone during insertion of the implant 3102 and removal of the inserter after the implant 3102 is inserted.
Once the implant 3102 is secured to the inserter, the disc implant 3102 is then inserted into the intervertebral space. The position of the implant 3102 may be determined using fluoroscopy to view the orientation of the implant 3102. Tantalum markers 3108q, 3110g (
In another form in accordance with the present invention illustrated in
The securing member is provided with three deployable arms 3206a having bone engaging head portions 3206b. The head portion 3206b preferably has a sharpened outer edge 3206c for easing penetration of the head portion 3206b into the bone. The head portions 3206b have a generally arcuate profile, with a convex outer edge 3206c and a concave inner surface 3206d for engaging with the arcuate outer surface of the elongate plunger 3212. Each head portion 3206b is connected to a transverse shaft 3206e via a neck portion 3206f. The transverse shaft 3206e is cylindrically shaped for being pivotally captured within similarly-shaped channel 3208b. The transverse shaft 3206e is held within the channel 3208b with a friction fit so that no additional fasteners or pieces are required to connect the restraining portions to the implant 3202. This construction simplifies manufacture and assembly, and increases the robustness of the implant. Because intervertebral implants in particular may be very small in many applications, it is desirable for such implants to have few components. For example, a cervical disc implant may only be 5 mm high. Thus, these kinds of implants must have components that are sturdy and robust enough to be functional on a very small scale.
The securing member receiving portion 3208a has a similar configuration to that of the embodiment described in
To actuate and deploy the deployable arms 3206a, the plunger 3212 is inserted into the cylindrical recess 3208g. The tapered tip 3212a interacts with the concave inner surface 3206d of the deployable arm 3206a, gradually biasing the arm 3206a upward, causing the arm 3206a to rotate about the transverse shaft portion 3206e. The deployable arm 3206a is deployed fully to its maximum height once the plunger tip extends beyond the concave inner surface 3206d, such that the deployable arm 3206a rests on top of and is supported by the shaft 3212b of the plunger 3212. As shown in
In another form in accordance with the present invention, an intervertebral implant 3302 having a deployable securing member 3306 for affixing the implant to the adjacent vertebra is disclosed in
The bendable elongate member 3306a is preferably a flat elongate member having a longitudinal length between its ends and a width. The elongate member 3306a has a leading end 3306b with an enlarged width that is inserted first into the receiving portion 3308a. A trailing end 3306c is provided with a transverse tab portion 3306d transverse to the longitudinal length thereof for manipulating the elongate member 3306a and providing a stop to keep the elongate member 3306a from being inserted too far into the intervertebral space. The trailing end 3306c is also provided with a guide portion 3306e having an enlarged width for guiding the elongate member 3306a within the insertion instrument 3314 and the securing member receiving portion 3308a. In addition, a central guide portion 3306f is positioned between the two ends for guiding the elongate member 3306a. In between either end 3306b, 3306c and the central guide portion 3306f is a bending zone 3306g which is configured for being bent during insertion of the elongate member 3306a and protruding upwardly or outwardly into engagement with the adjacent bone. The bending zone 3306g preferably includes perforations or weakened portions 3306h to promote bending at a predetermined location on the elongate member 3306a. In a preferred embodiment, the bending zones 3306g include a preformed protrusion or spike 3306i which lies within the elongate member prior to bending thereof. When the elongate member 3306a is bent, the bending zones are forced into an inverse V shape, causing the spike 3306i to be deployed upwards into the adjacent bone. Although the elongate member 3306a is shown with two bending zones 3306g and spikes 3306i, the elongate member 3306a may be provided with different numbers of bending zones and spikes. Although the bendable elongate member has portions bent into a V shape, other shapes and configurations are contemplated.
The securing member receiving portion 3308a takes the form of a generally U-shaped channel 3308b disposed along a lateral edge on the upper bearing member 3308. The channel 3308b has opposing side walls 3308c, 3308d and a bottom surface 3308e extending between the two side walls 3308c, 3308d. Extending between the side walls 3308c, 3308d are restraining members in the form of pins 3308f. The pins 3308f are operable to restrain the elongate bending member 3306a from bending at predetermined locations. Pins 3308f are preferably cylindrical or have radiused edges to prevent stress concentrations on the bending member 3306a and to reduce friction thereon during bending. Thus, the pins are located in positions corresponding to positions on the elongate bending member 3306a that are to remain unbent. The weakened portions 3306h on the elongate member 3306a are preferably aligned with the pins 3308f, such that when the bending member is inserted into the receiving portion 3308a, the bending member will bend in the open areas between the pins 3308f. As shown in
The insertion instrument 3314 comprises a generally C-shaped housing with opposing arms 3314a, 3314b to provide opposing grooves 3314c, 3314d in which the bending member may be inserted for guiding the bending member into the securing member receiving portion. The widened ends 3306b, 3306c and central portion 3306f fit within the grooves 3314c, 3314d. The transverse tab portion 3306d is sized and configured to fit between the opposing arms 3314a, 3314b such that it may pass therebetween. This way, the bending member 3306a may be pushed into the receiving portion via the transverse tab portion 3306d. The insertion instrument 3314 is also provided with an extended lip 3314e on the insertion end for providing the bending member 3306a with additional support to prevent bending of the member 3306a as it leaves the insertion instrument 3314 and prior to reaching the first pin 3308f at the entrance of the channel 3308b at the anterior side of the implant 3302.
In operation, the implant 3302 is first inserted into the prepared intervertebral space via an implant insertion instrument, which includes prongs 3316 which grasp the implant 3302 in opposing recesses on the inner facing surface of the upper bearing member 3308, as shown in
The securing member receiving portion 3308a for the elongate bending member 3306a is shown in
In other forms of the invention, the implant may comprise a pharmacological agent used for treating various spinal conditions, including degenerative disc disease, spinal arthritis, spinal infection, spinal tumor and osteoporosis. Such agents include antibiotics, analgesics, anti-inflammatory drugs, including steroids, and combinations thereof. Other such agents are well known to the skilled artisan. These agents are also used in therapeutically effective amounts. Such amounts may be determined by the skilled artisan depending on the specific case.
The pharmacological agents, if any, are preferably dispersed within the implant for in vivo release. The pharmacological agents may be dispersed in the spacer by adding the agents to the implant when it is formed, by soaking a formed implant in an appropriate solution containing the agent, or by other appropriate methods known to the skilled artisan. In other forms of the invention, the pharmacological agents may be chemically or otherwise associated with the implant. For example, the agents may be chemically attached to the outer surface of the implant.
Although the securing members and insertion tools have been described with reference to a disc replacement implant, the securing members and tools may be easily adapted for use with other artificial implants, such as fusion promoting implants, including vertebral body replacements, spinal cages, and the like. In addition, the invention described herein may also be applied to other motion preserving implants, such as those with articulating surfaces, including nucleus replacement implants. Moreover, the securing members, insertion tools, and methods described herein may be implemented in other weight-bearing joint implants, such as ankle, knee, or hip joint implants.
While the invention has been described with respect to specific examples including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described systems and techniques that fall within the spirit and scope of the invention as set forth in the claims.
Claims
1.-15. (canceled)
16. An integrated trial spacer and drill guide for sizing and preparing an intervertebral space for an intervertebral implant, the integrated trial spacer and drill guide comprising:
- a distal trial spacer portion sized and configured for being inserted between adjacent vertebral bones with an upper surface for being positioned adjacent an upper vertebral bone and a lower surface for being positioned adjacent a lower vertebral bone for determining a size of the intervertebral space;
- a drill guide portion located proximally from the distal trial spacer portion including at least one throughbore extending through the drill guide portion for receiving and guiding a drill bit within the throughbore along a longitudinal axis of thereof;
- wherein one of the upper and lower surfaces of the trial spacer portion is configured to guide the drill bit as it is advanced distally.
17. The integrated trial spacer and drill guide of claim 16, wherein each of the upper and lower surfaces of the trial spacer portion are separately configured to guide the drill bit as it is advanced distally.
18. The integrated trial spacer and drill guide of claim 16, further comprising at least one groove in the upper or lower surface of the trial spacer portion having a longitudinal axis aligned with the longitudinal axis of the at least one throughbore for allowing a distal end of the drill bit to be advanced distally out from the throughbore, and along the aligned groove in the intervertebral space for forming an elongate groove in the adjacent upper or lower vertebral bone.
19. The integrated trial spacer and drill guide of claim 16, wherein the at least one throughbore comprises first and second upper throughbores each for guiding a drill bit into the intervertebral space adjacent the upper surface of the distal trial spacer portion for forming a groove in the adjacent upper vertebral bone and a lower third throughbore for guiding a drill bit into the intervertebral space adjacent the lower surface of the distal trial spacer portion for forming a groove in the adjacent lower vertebral bone.
20. The integrated trial spacer and drill guide of claim 19, wherein the lower third throughbore includes a recessed tool receiving portion therein for receiving a corresponding gripping protrusion of an insertion tool.
21. The integrated trial spacer and drill guide of claim 19, further comprising first and second upper grooves in the upper surface of the trial spacer portion and a third lower groove in the lower surface of the trial spacer portion with the first, second and third grooves each being longitudinally aligned with the first, second and third throughbores, respectively.
22. The integrated trial spacer and drill guide of claim 19, wherein the third lower groove is located centrally in the lower surface of the trial spacer portion.
23. The integrated trial spacer and drill guide of claim 16, wherein upper and lower surfaces of the trial spacer portion include respective upper and lower faces that are generally flat and extend obliquely to each another.
24. The integrated trial spacer and drill guide of claim 16, wherein the drill guide has a proximal face, the at least one throughbore has a proximal end opening at the proximal face, and the proximal face includes at least one recess disposed adjacent the proximal end opening for receiving a corresponding guide protrusion of an insertion tool for the drill bit for fixing the integrated trial spacer and drill guide against axial rotation with respect to the insertion tool.
25. The integrated trial spacer and drill guide of claim 18, wherein the at least one groove includes a proximal counterbored portion for accommodating an enlarged portion of the drill bit.
26. A system for sizing and preparing a vertebral joint for an intervertebral implant, the system comprising:
- an integrated trial spacer and drill guide including a trial spacer portion configured to be inserted into an intervertebral space between adjacent vertebrae of the vertebral joint and a drill guide portion having a plurality of throughbores each with a longitudinal axis configured to receive and guide a drill bit as the drill bit is advanced along the longitudinal axis into the intervertebral space;
- a drill bit set including a plurality of drill bits having shafts of differing lengths; and
- a trial spacer inserter tool configured to releasably hold the integrated trial spacer and drill guide at an inserter tool engagement portion thereof.
27. The system of claim 26, wherein the plurality of drill bits each include a distal end, a proximal end, and a cutting portion including a distal cutting surface at the distal end and a counterbore cutting portion located proximally of the distal cutting surface for forming a counterbore in one of the adjacent vertebrae.
28. The system of claim 27, wherein the plurality of drill bits each includes a collar which is enlarged relative to the cutting portion and which is located proximally of the cutting portion for providing an abutment surface to abut against a proximal end of the drill guide portion for limiting a distance the drill bit may be inserted into the intervertebral space.
29. The system of claim 26, wherein the plurality of drill bits each includes a distal cutting portion having a diameter, wherein the distal cutting portion of each of the plurality of drill bits has the same diameter.
30. The system of claim 26, wherein the trial spacer inserter tool includes a shaft with a distal gripping portion configured to fit inside one of the plurality of throughbores for holding the integrated trial spacer and drill guide at the inserter tool engagement portion thereof in the one throughbore of the drill guide portion.
31. The system of claim 30, wherein the distal gripping portion is expandable in a radial direction for gripping the inserter tool engagement portion of the integrated trial spacer and drill guide.
32. A method of preparing a vertebral joint for an intervertebral implant, the method comprising:
- inserting an integrated trial spacer and drill guide into a space between adjacent upper and lower vertebral bones;
- inserting a first drill bit into a drill guide portion of the integrated trial spacer and drill guide;
- forming a first groove in one of the upper and lower vertebral bones with the first drill bit;
- inserting a second drill bit into the drill guide portion;
- forming a second groove in one of the upper and lower vertebral bones with the second drill bit while the first drill bit is positioned within the first groove and the drill guide portion.
33. The method of claim 32, wherein the first and second grooves are formed in the upper vertebral bone.
34. The method of claim 32, further comprising forming a counterbore in the one of the upper and lower vertebral bones at a proximal portion of the first groove.
35. The method of claim 32, wherein the second drill bit is longer than the first drill bit.
36. The method of claim 32, further comprising:
- inserting a third drill bit into the drill guide;
- forming a third groove in one of the upper and lower vertebral bones with the third drill bit while the first and second drill bits are positioned respectively within the first and second grooves, and within the drill guide portion.
37. The method of claim 36, wherein two of the first, second, and third grooves are formed in the upper vertebral bone, and the other of the first, second, and third grooves is formed in the lower vertebral bone.
38. The method of claim 36, wherein the third drill bit is longer than the second drill bit.
39. The method of claim 32, wherein the integrated trial spacer and drill guide is inserted into the space between adjacent upper and lower vertebral bones with an insertion tool to which the integrated trial spacer and drill guide is removably attached.
40. The method of claim 39, further comprising removing the insertion tool from the integrated trial spacer and drill guide after the first and second grooves are formed;
- inserting a third drill bit into the drill guide;
- forming a third groove in one of the upper and lower vertebral bones with the third drill bit while the first and second drill bits are positioned respectively within the first and second grooves, and within the drill guide portion.
Type: Application
Filed: Sep 24, 2018
Publication Date: Mar 28, 2019
Inventors: Jeffrey L. Trudeau (Marquette, MI), Brian Patrick Janowski (Marquette, MI), Thomas Kilpela (Marquette, MI), Michael R. Jackson (Hancock, MI), Qi-Bin Bao (Edina, MN)
Application Number: 16/139,175
