Patent Grant
10213322
The present invention is directed to a spinal joint replacement implant and more particularly to a cervical intervertebral disc implant having saddle shaped articulating surfaces and to methods of inserting the cervical intervertebral disc implant.
As is well known to those skilled in the art, the structure of the intervertebral disc disposed between the cervical bones in the human spine comprises a peripheral fibrous shroud (the annulus) which circumscribes a spheroid of flexibly deformable material (the nucleus). The nucleus comprises a hydrophilic, elastomeric cartilaginous substance that cushions and supports the separation between the bones while also permitting articulation of the two vertebral bones relative to one another to the extent such articulation is allowed by the other soft tissue and bony structures surrounding the disc. The additional bony structures that define pathways of motion in various modes include the posterior joints (the facets) and the lateral intervertebral joints (the unco-vertebral joints). Soft tissue components, such as ligaments and tendons, constrain the overall segmental motion as well.
Traumatic, genetic, and long term wearing phenomena contribute to the degeneration of the nucleus in the human spine. This degeneration of this critical disc material, from the hydrated, elastomeric material that supports the separation and flexibility of the vertebral bones, to a flattened and inflexible state, has profound effects on the mobility (instability and limited ranges of appropriate motion) of the segment, and can cause significant pain to the individual suffering from the condition. Although the specific causes of pain in patients suffering from degenerative disc disease of the cervical spine have not been definitively established, it has been recognized that pain may be the result of neurological implications (nerve fibers being compressed) and/or the subsequent degeneration of the surrounding tissues (the arthritic degeneration of the facet joints) as a result of their being overloaded.
Traditionally, the treatment of choice for physicians caring for patients who suffer from significant degeneration of the cervical intervertebral disc is to remove some, or all, of the damaged disc. In instances in which a sufficient portion of the intervertebral disc material is removed, or in which much of the necessary spacing between the vertebrae has been lost (significant subsidence), restoration of the intervertebral separation is required.
Unfortunately, until the advent of spine arthroplasty devices, the only methods known to surgeons to maintain the necessary disc height necessitated the immobilization of the segment Immobilization is generally achieved by attaching metal plates to the anterior or posterior elements of the cervical spine, and the insertion of some osteoconductive material (autograft, allograft, or other porous material) between the adjacent vertebrae of the segment. This immobilization and insertion of osteoconductive material has been utilized in pursuit of a fusion of the bones, which is a procedure carried out on tens of thousands of pain suffering patients per year.
This sacrifice of mobility at the immobilized, or fused, segment, however, is not without consequences. It was traditionally held that the patient's surrounding joint segments would accommodate any additional articulation demanded of them during normal motion by virtue of the fused segment's immobility. While this is true over the short-term (provided only one, or at most two, segments have been fused), the effects of this increased range of articulation demanded of these adjacent segments has recently become a concern. Specifically, an increase in the frequency of returning patients who suffer from degeneration at adjacent levels has been reported.
Whether this increase in adjacent level deterioration is truly associated with rigid fusion, or if it is simply a matter of the individual patient's predisposition to degeneration is unknown. Either way, however, it is clear that a progressive fusion of a long sequence of vertebrae is undesirable from the perspective of the patient's quality of life as well as from the perspective of pushing a patient to undergo multiple operative procedures.
While spine arthroplasty has been developing in theory over the past several decades, and has even seen a number of early attempts in the lumbar spine show promising results, it is only recently that arthroplasty of the spine has become a truly realizable promise. The field of spine arthroplasty has several classes of devices. The most popular among these are: (a) the nucleus replacements, which are characterized by a flexible container filled with an elastomeric material that can mimic the healthy nucleus; and (b) the total disc replacements, which are designed with rigid baseplates that house a mechanical articulating structure that attempts to mimic and promote the healthy segmental motion.
Among these solutions, the total disc replacements have begun to be regarded as the most probable long-term treatments for patients having moderate to severe lumbar disc degeneration. In the cervical spine, it is likely that these mechanical solutions will also become the treatment of choice. At present, there are two devices being tested clinically in humans for the indication of cervical disc degeneration. The first of these is the Bryan disc, disclosed in part in U.S. Pat. No. 6,001,130. The Bryan disc is comprised of a resilient nucleus body disposed in between concaval-covex upper and lower elements that retain the nucleus between adjacent vertebral bodies in the spine. The concaval-convex elements are L-shaped supports that have anterior wings that accept bones screws for securing to the adjacent vertebral bodies.
The second of these devices being clinically tested is the Bristol disc, disclosed substantially in U.S. Pat. No. 6,113,637. The Bristol disc is comprised of two L-shaped elements, with corresponding ones of the legs of each element being interposed between the vertebrae and in opposition to one another. The other of the two legs are disposed outside of the intervertebral space and include screw holes through which the elements may be secured to the corresponding vertebra; the superior element being secured to the upper vertebral body and the inferior element being attached to the lower vertebral body. The opposing portions of each of the elements comprise the articulating surfaces that include an elliptical channel formed in the lower element and a convex hemispherical structure disposed in the channel.
As is evident from the above descriptions, the centers of rotation for both of these devices, which are being clinically tested in human subjects, is disposed at some point in the disc space. More particularly with respect to the Bryan disc, the center of rotation is maintained at a central portion of the nucleus, and hence in the center of the disc space. The Bristol disc, as a function of its elongated channel (its elongated axis being oriented along the anterior to posterior direction), has a moving center of rotation which is at all times maintained within the disc space at the rotational center of the hemispherical ball (near the top of the upper element).
Thus, there remains a need for improved intervertebral discs, as well as new and improved methods for safely and efficiently implanting intervertebral discs.
Disclosed herein are intervertebral discs or implants, surgical instruments and procedures in accordance with certain preferred embodiments of the present invention. It is contemplated, however, that the implants, instruments and procedures may be slightly modified, and/or used in whole or in part and with or without other instruments or procedures, and still fall within the scope of the present invention. Although the present invention may discuss a series of steps in a procedure, the steps can be accomplished in a different order, or be used individually, or in subgroupings of any order, or in conjunction with other methods, without deviating from the scope of the invention.
In certain preferred embodiments of the present invention, a method of inserting an intervertebral disc into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies, securing a first pin to the first vertebral body and a second pin to the second vertebral body, and using the first and second pins for distracting the disc space. The method preferably includes providing an inserter holding the intervertebral disc, engaging the inserter with the first and second pins, and advancing at least a portion of the inserter toward the disc space for inserting the intervertebral disc into the disc space, wherein the first and second pins align and guide the inserter toward the disc space.
In certain preferred embodiments, the inserter desirably includes an inserter head having an upper channel and a lower channel. During the advancing step, the first pin is preferably in contact with the upper channel and the second pin is preferably in contact with the lower channel. The channels may taper inwardly toward one another for urging the first and second pins away from one another as the inserter advances toward the disc space (preferably to more fully open the disc space as the inserter advances toward the disc space). In certain preferred embodiments, the inserter head has a distal end adapted to contact vertebral bone and a proximal end, and the upper and lower channels taper inwardly toward one another between the proximal and distal ends of the inserter head. As a result, the channels are closer together near the distal end of the inserter than near the proximal end of the inserter. In preferred embodiments, the inserter head includes distally extending arms for securing an intervertebral disc implant. Each of the distally extending arms may include an inwardly extending projection engageable with the intervertebral disc implant.
In other preferred embodiments of the present invention, a method of inserting an intervertebral disc implant into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies, securing a first pin to the first vertebral body and a second pin to the second vertebral body, and using the first and second pins for distracting the disc space. The method may include engaging a chisel guide having a distal head with the first and second pins, and advancing the chisel guide toward the disc space for inserting the distal head of the chisel guide into the disc space, whereby the first and second pins align and guide the chisel guide as the chisel guide advances toward the disc space. The method may also include coupling a chisel having one or more cutting blades with the chisel guide and advancing the one or more cutting blades toward the first and second vertebral bodies for forming channels in one or more endplates of the first and second vertebral bodies. The distal head of the chisel guide preferably has a top surface with at least one groove formed therein for guiding the one or more chisel blades toward the disc space. The bottom surface of the head may also have at least one groove for guiding the chisel.
The method may also include providing an inserter holding an intervertebral disc implant, and after forming channels in the one or more endplates of the first and second vertebral bodies, disengaging the chisel guide from the first and second pins and engaging the inserter with the first and second pins. The inserter is preferably advanced toward the disc space for inserting the intervertebral disc implant into the disc space, whereby the first and second pins align and guide the inserter as the inserter advances toward the disc space.
In other preferred embodiments of the present invention, a kit includes a plurality of two-part intervertebral disc implants having different sizes, and a plurality of implant dispensers, each implant dispenser holding together the two parts of one of the two-part intervertebral disc implants so that it can be manipulated as a single implantable unit. Each implant dispenser preferably has indicia corresponding to the size of the intervertebral disc implant held by the implant dispenser. The indicia on the implant dispenser may include a color code or text indicating the size of the intervertebral disc implant held by the implant dispenser.
In particular preferred embodiments, each intervertebral disc implant has a top element including a bone engaging surface and an articulating surface and a bottom element including a bone engaging surface and an articulating surface. The implant dispenser desirably holds the articulating surfaces of the top and bottom elements in contact with one another.
The implant dispensers may be flexible. In preferred embodiments, an implant dispenser includes a first arm engaging a top element of the intervertebral disc implant, a second arm engaging a bottom element of the intervertebral disc implant, and a connecting element for interconnecting the first and second arms. The connecting element is preferably flexible for enabling the first and second arms to move away from one another for releasing the intervertebral disc.
The kit may also include a plurality of inserters, the inserters being adapted to couple with the intervertebral disc implants while the intervertebral disc implants are held in the implant dispensers, so that the intervertebral disc implants can be transferred from the implant dispensers to the inserters. Each inserter preferably has indicia corresponding to the size of a corresponding one of the intervertebral disc implants. The indicia on the inserter may include a color code or text. The intervertebral disc implants are preferably transferable from the implant dispensers to the inserters while being maintained as a single implantable unit. In certain preferred embodiments, an implant inserter will couple directly to the intervertebral disc implant while the disc implant is held by an implant dispenser.
In other preferred embodiments of the present invention, a template for marking score lines on a spinal segment includes a shaft having a proximal end and a distal end, and a template marker provided at the distal end of the shaft. The template marker preferably includes a cruciform-shaped structure having a first vertical arm and a second vertical arm that extends away from the first arm, the first and second vertical arms being aligned with one another along a first axis. The cruciform-shaped structure also preferably includes a first lateral arm and a second lateral arm extending away from the first lateral arm, the first and second lateral arms being aligned with one another along a second axis, whereby distal surfaces of the first and second lateral arms form a concave curved surface that conforms to an anterior surface of a disc between superior and inferior vertebral bodies.
The template may include a central pin or a plurality of pins provided at the distal end of the lateral arms for being inserted into the natural disc for stabilizing the template adjacent the disc space, and the vertical arms and the lateral arms spread outwardly from the distal end of the shaft. The first vertical arm desirably includes a first distally extending tack for engaging an anterior surface of the first vertebral body and the second vertical arm desirably includes a second distally extending tack for engaging an anterior surface of the second vertebral body.
In certain preferred embodiments of the present invention, each of the top and bottom elements of the implant has an anterior wall that preferably connects the anterior ends of the protrusions on the element. The anterior wall preferably serves as a vertebral body stop to prevent over-insertion of the implant and/or posterior migration of the implant. The anterior wall preferably serves as an engageable feature for engagement with instruments, including but not limited to tamps, extraction or repositioning instruments. The anterior wall in some embodiments may have a curved posterior face to sit flush against a curved anterior endplate face. At least the posterior surface of the wall may be coated with an osteoconductive material to facilitate long-term fixation to the endplate surface.
In certain preferred embodiments of the present invention, the intervertebral disc implants includes a top element and a bottom element. Each implant part may have protrusions with outwardly laterally facing surfaces. One or more of the outwardly laterally facing surfaces may have a vertically extending channel, or groove, or depression, or like feature for engagement with instruments, including but not limited to insertion, extraction or repositioning instruments. Preferably, the surface of this feature can be coated with an osteoconductive material to facilitate long-term fixation to the endplate bone.
In certain preferred embodiments, the intervertebral disc implant, or the instruments, may alternatively or additionally incorporate any or all of the features discussed previously, disclosed herein, or discussed in U.S. patents and/or patent applications incorporated by reference herein. Preferably, the configuration of the bearing surfaces of the intervertebral disc implant in this preferred embodiment may be substantially similar to those of the other bearing surface configurations discussed previously, disclosed herein, or incorporated by reference herein.
Prior to insertion of the intervertebral disc implant disclosed herein, a surgeon preferably performs a cervical anterior exposure and initial natural disc removal (e.g., discectomy). After simple exposure and initial natural disc removal, the surgeon may introduce a guide, such as a reference pin drill guide that enables the surgeon to anchor a pair of alignment or reference pins (e.g., Caspar pins) into the adjacent vertebral bones, preferably along the midline of the bones, and at predetermined vertical distances from the endplate edges.
The present application discloses the use of reference or alignment pins for properly aligning tooling and/or implants with bone. The reference or alignment pins shown herein are merely representative examples of certain preferred embodiments of the present invention. It is contemplated that other reference or alignment tools and techniques may be used for properly aligning tools and/or implants with bone, and that these other reference or alignment tools and techniques are within the scope of the present invention.
With the reference pins in place, the surgeon may apply distraction to the disc space by using a distraction tool, such as a standard Caspar distractor, and then complete the discectomy and distraction. Once the disc space is cleared and restored to a desired height, the surgeon may choose to remove the distraction tools and advance a guide, such as a burr or drill guide along the reference pins and into the disc space. The burr or drill guide preferably engages the reference pins as the burr/drill guide is advanced toward the disc space. Thus, the reference pins serve to provide proper alignment of the burr/drill guide relative to the disc space. In certain preferred embodiments, the burr/drill guide includes a distal head that fits within the disc space. The burr/drill guide preferably permits the surgeon to introduce a burr or drill bit through each of four holes in the guide and burr or drill pilot grooves or holes at predetermined locations in the endplates. As will be described in more detail below, the pilot grooves are used to form protrusion channels for the protrusions of the intervertebral disc.
In certain preferred embodiments of the present invention, in order to cut protrusion channels in the endplates, a chisel guide may be utilized. The chisel guide preferably includes a distal head that is insertable into the disc space. The distal head preferably has grooves formed in top and bottom surfaces of the distal head for guiding a chisel for cutting protrusion channels. The chisel guide preferably has alignment openings for sliding over the reference pins. The reference pins preferably align and direct the chisel guide into the disc space. Chisels may then be advanced along the sides of the chisel guide for cutting the protrusion channels. In certain preferred embodiments of the present invention, a first pair of chisels (e.g., roughening chisels) is advanced along the sides of chisel guide to cut channels. Preferably, the first pair of chisels cuts channels that are approximately 1 mm wide. A second pair of larger chisels (e.g., finishing chisels) can be used to widen the protrusion channels, preferably to about 2 mm. In other preferred embodiments of the present invention, a first pair of chisels is approximately 1 mm wide and 1.5 mm high, and a second pair of chisels (e.g., the finishing chisels) are 1.5 mm wide and 2.5 mm high.
Once the protrusion channels have been cut, the implant may be mounted to an insertion tool (e.g., to the distal tip of an insertion tool) and inserted into the disc space. The insertion tool preferably includes upper and lower guide slots or openings that permit the insertion tool to slide along the reference pins. The guide slots are preferably ramped so that the disc space is distracted (to preferably approximately 2 mm wider than the height of the implant) to ensure easy insertion of the implant. In other preferred embodiments, the reference pins may also be engaged by a distraction tool to distract the disc space during insertion, e.g., if such distraction is necessary. This additional distraction may ensure that the device is implanted easily without requiring excessive impacting.
Once the intervertebral disc implant has been inserted into the disc space, a tamping instrument may be used to adjust the final position of the disc components relative to one another and/or relative to the vertebral bones. Should the surgeon want to remove the device intra-operatively, or in the case of a revision, a proximal feature of the device (e.g., an anterior wall) may be engaged by an instrument (e.g., an extraction instrument) to pull the device free from the disc space.
In other preferred procedures, after simple exposure and initial disc removal, the surgeon may introduce a guide, such as a reference pin grill guide, that permits the surgeon to drill guide holes in superior and inferior vertebral bodies (preferably parallel to one another) for the placement of the pair of reference pins. A second guide, such as a sleeve or reference pin driver guide may be used to ensure that the reference pins are placed in the pre-drilled holes so that the pins are parallel, and are driven into the adjacent vertebral bones preferably along the midline of the bones, and at predetermined distances from the endplates.
With the reference pins in place, the surgeon may apply distraction to the disc space, e.g., by means of a distraction tool, and then complete the discectomy and distraction. The surgeon should preferably remove any anterior or posterior osteophytes that may interfere with the ultimate placement of the implant.
It should be noted that features and methods and functionalities of the present invention, including but not limited to features and methods and functionalities for engaging one tool (or parts thereof) with one or more other tools (or parts thereof) or with the implants (or parts thereof), and vice-versa; for addressing, avoiding, manipulating, or engaging the patient's anatomy; for aligning one or more tools with anatomic or non-anatomic reference points; and for aligning the tools and implants with one another and/or a treatment space; are not and should not be limited to those embodied in and achieved by the structures and methods of the specific embodiments described and shown, but rather the structures and methods of the specific embodiments described and shown are merely examples of structures and methods that can achieve certain features and methods and functionalities of the present invention.
These and other preferred embodiments of the present invention will be described in more detail below.
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The articulating surfaces may be similar to the articulating surfaces disclosed in commonly assigned U.S. Pat. No. 6,997,955. In certain preferred embodiments of the present invention, the longitudinally inwardly directed articulation surface of the top element 102 forms a constant radii saddle-shaped articulation surface. More particularly, the saddle surface is defined by a concave arc that is swept perpendicular to and along a convex arc. The articulation surface has a cross-section in one plane that forms a concave arc, and a cross-section in another plane (perpendicular to that plane) that forms a convex arc. The concave arc has a respective constant radius of curvature about an axis perpendicular to the one plane. The convex arc has a respective constant radius of curvature about an axis perpendicular to the other plane.
In a preferred embodiment, the concave arc has a constant radius of curvature A about an axis perpendicular to the anterior-posterior plane, and the convex arc has a constant radius of curvature B about an axis perpendicular to the lateral plane. Preferably, radius A is less than radius B.
The longitudinally inwardly directed articulation surface of the bottom element 104 also preferably forms a constant radii saddle-shaped articulation surface. More particularly, the saddle surface is defined by a convex arc that is swept perpendicular to and along a concave arc. The articulation surface has a cross-section in one plane that forms a convex arc, and a cross-section in another plane (perpendicular to that plane) that forms a concave arc. The convex arc has a respective constant radius of curvature about an axis perpendicular to the one plane. The concave arc has a respective constant radius of curvature about an axis perpendicular to the other plane.
In a preferred embodiment, the convex arc has a constant radius of curvature C about an axis perpendicular to the anterior-posterior plane, and the concave arc has a constant radius of curvature D about an axis perpendicular to the lateral plane. Preferably, radius C is less than radius D.
The constant radii saddle shaped articulation surfaces are configured and sized to be nestable against one another and articulatable against one another, to enable adjacent vertebral bones (against which the top and bottom elements are respectively disposed in the intervertebral space) to articulate in flexion, extension, and lateral bending. More particularly, the intervertebral disc of the present invention is assembled by disposing the top and bottom elements so that the vertebral body contact surfaces are directed away from one another, and the articulation surfaces are nested against one another such that the concave arcs accommodate the convex arcs.
Accordingly, movement of the adjacent vertebral bones relative to one another is permitted by the movement of the top and bottom elements relative to one another. In flexion and extension, the concave arcs of the top element 102 ride on the convex arcs of the bottom element 104 about a center of rotation below the articulation surfaces. In lateral bending, the concave arcs of the bottom element 104 ride on the convex arcs of the top element 102 about a center of rotation above the articulation surfaces. During these articulations, the elements are maintained at constant relative distraction positions, i.e., the elements do not move in directions that are directed away from one another (for example, do not move in opposing axial directions from one another (e.g., along a longitudinal axis of the spine)). Accordingly, in certain preferred embodiments, the present invention provides a pair of articulation surfaces that have a center of rotation above the surfaces in one mode of motion (e.g., lateral bending), and below the surfaces in another (e.g., flexion/extension), consistent in these regards with a natural cervical intervertebral joint. Preferably, the articulation surfaces are sized and configured so that the respective ranges of angles through which flexion/extension and lateral bending can be experienced are equal to or greater than the respective normal physiologic ranges for such movements in the cervical spine.
It is preferable that, in addition to the flexion, extension, and lateral bending motions described above, the adjacent vertebral bones be permitted by the intervertebral disc implant to axially rotate relative to one another (e.g., about the longitudinal axis of the spinal column) through a small range of angles without moving in opposite (or otherwise directed away from one another) directions (e.g., along the longitudinal axis) within that range, and then to engage in such opposite (or otherwise directed away from one another) movement once that range is exceeded. Preferably, the articulation surfaces are accordingly configured and sized to permit such movements. Because of the differing radii of the opposing articulation surfaces, the top and bottom elements are able to axially rotate relative to one another about the longitudinal axis of the spinal column through a range of angles without causing the vertebral body contact surfaces to move away from one another along the longitudinal axis. Once the axial rotation exceeds that range, the articulation surfaces interfere with one another as the concave arcs move toward positions in which they would be parallel to one another, and the distance between the vertebral body contact surfaces increases with continued axial rotation as the concave arcs ride up against their oppositely directed slopes. Thus, the articulation surfaces are configurable according to the present invention to permit normal physiologic axial rotational motion of the adjacent vertebral bones about the longitudinal axis through a range of angles without abnormal immediate axially opposite (or otherwise directed away from one another) movement, and to permit such axially opposite (or otherwise directed away from one another) movement when under normal physiologic conditions it should occur, that is, outside that range of angles.
The articulation surfaces preferably maintain contact over a range of normal physiologic articulating movement between the adjacent vertebral bones. That is, through flexion, extension, lateral bending, and axial rotation, the articulation surfaces are in contact with one another. Preferably, the surface area dimensions of the articulation surfaces are selected in view of the selected radii of curvature to prevent the edges of the saddle surfaces (particularly the edges of the concave arcs) from hitting any surrounding anatomic structures, or other portions of the opposing upper or lower element, before the limit of the normal physiologic range of an attempted articulation is reached.
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The drill bit 228 includes a distal end 226 and a proximal end 234 adapted to be secured by a drill. The drill bit 228 includes a shoulder 236 that limits advancement of the drill bit through the openings 210, 212 of the main body 204.
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The sizer also includes vertebral body stops 424 and 426 for limiting insertion of the sizer. Referring to
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Disclosed herein are implants, surgical instruments and procedures in accordance with certain preferred embodiments of the present invention. It is contemplated, however, that the implants, instruments and procedures may be slightly modified, and/or used in whole or in part and with or without other instruments and procedures, and still fall within the scope of the present invention. Although the present invention may discuss a series of steps in a procedure, the steps may be accomplished in a different order, or may be used individually, or in conjunction with other methods, without deviating from the scope of the present invention.
Prior to implanting the intervertebral disc implant, a review of X-rays, MRI or CT-myelogram is preferably conducted to assess the level to be treated for osteophytes and to compare the intervertebral disc height with the adjacent levels. Referring to
Another step in the intervertebral disc implantation procedure involves identifying and marking a midline on the target segment of the spine. In preferred embodiments, a template, such as the template shown and described above in
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In particular preferred embodiments, different sized reference pins may be used. These different sized reference pins may include shafts having different diameters and/or lengths. In certain preferred embodiments, a small and a large set of reference pins is provided in an instrument tray. The smaller of the pair of reference pins should be inserted initially. If the smaller pair of reference pins proves unsatisfactory, the larger pair of reference pins may be utilized. As shown in
Once the reference pins are in place, a surgeon may preferably apply distraction to the disc space by using a distraction tool, such as a distractor as shown and described in
The distractor is then utilized to apply distraction to the targeted spinal segment. During the distraction procedure, the facets and the disc space are preferably monitored under fluoroscopy to ensure a complete distraction. The amount of distraction should not exceed the height of the adjacent disc space. As noted above, fluoroscopy should be used to monitor the distraction height so as to prevent over-distraction. As is well known to those skilled in the art, over-distraction may cause nerve and/or facet damage.
After the targeted spinal segment has been distracted, the discectomy procedure is completed. In preferred embodiments, the posterior and lateral margins of the disc space are cleared of any extraneous matter. The clearing of the posterior and lateral margins preferably extends to the uncinate processes and all the way back to the nerve root and canal. In certain preferred embodiments, lateral fluoroscopy is utilized to check the anterior aspects of the vertebral body for osteophytes. A cutting tool, such as a burr, may be used to further prepare the endplates of the opposing superior and inferior vertebral bodies. The cutting tool may be utilized to smooth out the curvature of the superior endplate. After the discectomy has been completed, the endplates of the adjacent vertebral bodies are preferably parallel to one another and relatively uniform, thereby preventing undersizing of the implant.
In certain preferred embodiments, the decompression of the targeted disc space may be completed by removing any posterior osteophytes or soft tissue material that may inhibit the full distraction of the posterior portion of the targeted disc space. In certain preferred embodiments, it may be necessary to remove the posterior longitudinal ligament (PLL) to achieve optimal restoration of the disc height, decompression and release for post-operative motion. In addition, the posteriolateral corners of the endplates may be resected as needed to provide neural decompression. In certain instances, it may be necessary to remove the posteriolateral uncovertebral joints. The lateral uncovertebral joints are preferably not removed unless they are causing nerve root compression. In addition, in certain preferred embodiments it may be necessary to perform a foraminotomy if there are symptoms of neural/foraminal stenosis.
In certain preferred embodiments, another stage of the intervertebral disc implantation method involves initial endplate preparation including drilling pilot grooves in the superior and inferior vertebral bodies. After complete distraction has taken place, the distractor shown in
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In certain preferred embodiments, channels for the protrusions of the intervertebral disc implant are formed in the endplates of the superior and inferior vertebral bodies. Referring to
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In certain preferred embodiments, a sizing operation is conducted to determine the proper size of the intervertebral disc that will be placed into the targeted disc space. Referring to
After starting with a sizer having a height of 5 mm, sequentially larger sizers are utilized to determine the desired implant height that will best fit into the disc space without over tensioning the annulus. The correct height for the sizer is preferably determined when the sizer fits snugly into the disc space with mild to moderate resistance to retraction of the sizer. The width of the disc space may also be checked by using a sizer having a different width and inserting the sizer into the disc space. In certain preferred embodiments, the sizer may include alignment openings that engage the reference pins for guiding the sizer as it is advanced toward the disc space.
In certain preferred embodiments, a trial is inserted into the disc space to complete preparation of the channels for the protrusions of the intervertebral disc. Referring to
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In certain preferred embodiments, an appropriately sized intervertebral disc implant is then selected and inserted into a targeted disc space. Referring to
In preferred embodiments, prior to insertion of the intervertebral disc implant, the size label on the implant is inspected and the size label on the implant dispenser is also inspected to ensure that the correctly sized implant was selected and that the top or superior element of the implant is oriented for proper insertion. In preferred embodiments, an implant is selected having a height and baseplate dimensions that match the corresponding sizer that restored the desired height of the disc space without over-tensioning the annulus or damaging the facets.
After an appropriately sized intervertebral disc implant has been selected, an inserter head, such as the inserter head shown and described above in
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In certain preferred embodiments, the inserter head is attached to a handle. The attachment may include a threaded attachment whereby a t-bar or handle is rotated to threadably engage the inserter head with the handle.
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In certain preferred embodiments, the intervertebral disc implant is inserted into a prepared disc space. Referring to
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In certain preferred embodiments, the T-handle may be rotated approximately three or four turns for advancing the intervertebral disc implant 100 into the disc space. The proximal end of the handle for the inserter head may be impacted to ensure that the intervertebral disc implant continues into the disc space as the four arms of the inserter head remain in contact with the vertebral bodies.
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Following surgery, in certain preferred embodiments, a goal of post-operative rehabilitation is to return the patient to normal activity as soon as possible without jeopardizing soft and hard tissue healing. Preferably, the patient should wear a soft collar for approximately 1-2 weeks to support healing of the incision. The patient's rehabilitation program may be modified under the direction of a surgeon to take into consideration the patient's age, stage of healing, general health, physical condition, life-style, and activity goals. Adherence to a recommended rehabilitation program is highly desirable.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
This application is a continuation of U.S. patent application Ser. No. 14/956,844, filed Dec. 2, 2015, which is a continuation of U.S. patent application Ser. No. 14/746,347, filed Jun. 22, 2015, now U.S. Pat. No. 9,226,837, which is a continuation of U.S. patent application Ser. No. 14/153,514, filed Jan. 13, 2014, now U.S. Pat. No. 9,095,451, which is a divisional of U.S. patent application Ser. No. 11/439,808, filed May 24, 2006, now U.S. Pat. No. 8,777,959, which claims the benefit of the filing dates of U.S. Provisional Patent Application No. 60/790,415, filed Apr. 7, 2006, 60/721,053, filed Sep. 27, 2005, 60/701,306, filed Jul. 21, 2005 and 60/685,295, filed May 27, 2005, the disclosures of which are hereby incorporated by reference herein. The present application relates to U.S. Pat. No. 6,908,484, entitled “Cervical Disc Replacement” and filed on Mar. 6, 2003; U.S. Pat. No. 6,994,728, entitled “Cervical Disc Replacement Method” and filed on Feb. 11, 2004; U.S. Patent Application Publication No. 2004/0176851, entitled “Cervical Disc Replacement” and filed on Feb. 11, 2004; U.S. Pat. No. 6,994,729, entitled “Cervical Disc Replacement” and filed on Feb. 11, 2004; U.S. Pat. No. 6,997,955, entitled “Cervical Disc Replacement” and filed on Feb. 11, 2004; U.S. Pat. No. 6,972,037, entitled “Cervical Disc Replacement” and filed on Feb. 11, 2004; U.S. Pat. No. 6,972,038, entitled “Cervical Disc Replacement” and filed on Feb. 11, 2004; U.S. Pat. No. 6,997,954, entitled “Cervical Disc Replacement Method” and filed on Feb. 11, 2004; U.S. Patent Application Publication No. 2005/0240272, entitled “Cervical Disc Replacement” and filed on May 9, 2005; U.S. Patent Application Publication No. 2005/0240271, entitled “Cervical Disc Replacement” and filed on May 9, 2005; U.S. Patent Application Publication No. 2005/0240270, entitled “Cervical Disc Replacement” and filed on May 9, 2005; U.S. Pat. No. 6,896,676, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Oct. 17, 2003; U.S. Patent Application Publication No. 2004/0176773, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176843, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176778, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176777, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176852, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176774, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0176772, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2004/0220590, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 18, 2004; U.S. Patent Application Publication No. 2005/0071013, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Nov. 19, 2004; and U.S. Patent Application Publication No. 2004/0193272, entitled “Instrumentation And Methods For Use In Implanting A Cervical Disc Replacement Device” and filed on Feb. 19, 2004, the disclosures of which are hereby incorporated by reference herein. The present application also relates to U.S. Pat. No. 6,607,559, entitled “Trial Intervertebral Distraction Spacers” and filed on Jul. 16, 2001; U.S. patent application Ser. No. 10/436,039, entitled “Trial Intervertebral Spacers” and filed May 12, 2003; U.S. patent Ser. No. 10/128,619, entitled “Intervertebral Spacer Having A Flexible Wire Mesh Vertebral Body Contact Element” and filed Apr. 23, 2002; U.S. patent application Ser. No. 11/073,987, entitled Intervertebral Spacer Having A Flexible Wire Mesh Vertebral Body Contact Element; U.S. patent application Ser. No. 10/140,153, entitled “Artificial Intervertebral Disc Having A Flexible Wire Mesh Vertebral Body Contact Element” and filed May 7, 2002; U.S. patent application Ser. No. 10/151,280, entitled “Tension Bearing Artificial Disc Providing A Centroid Of Motion Centrally Located Within An Intervertebral Space” and filed May 20, 2002; U.S. patent application Ser. No. 10/175,417, entitled “Artificial Intervertebral Disc Utilizing A Ball Joint Coupling” and filed Jun. 19, 2002; U.S. patent application Ser. No. 10/256,160, entitled “Artificial Intervertebral Disc” and filed Sep. 26, 2002; U.S. patent application Ser. No. 10/294,983, entitled “Artificial Intervertebral Disc Having A Captured Ball And Socket Joint With A Solid Ball And Retaining Cap” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/294,982, entitled “Artificial Intervertebral Disc” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/294,981, entitled “Artificial Intervertebral Disc Having A Captured Ball And Socket Joint With A Solid Ball And Compression Locking Post” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/642,523, entitled “Axially Compressible Artificial Intervertebral Disc Having Limited Rotation Using A Captured Ball and Socket” and filed Aug. 15, 2003; U.S. patent application Ser. No. 10/642,522, entitled Artificial Intervertebral Disc Having A Circumferentially Buried Wire Mesh Endplate Attachment Device and filed Aug. 15, 2003; U.S. patent application Ser. No. 11/073,987, entitled “Intervertebral Spacer Device Having A Circumferentially Buried Wire Mesh Endplate Attachment Device” and filed Aug. 15, 2003; U.S. patent application Ser. No. 10/642,526, entitled “Circumferentially Buried Wired Mesh Endplate Attachment Device For Use With An Orthopedic Device” and filed Aug. 15, 2003; U.S. patent application Ser. No. 10/294,984, entitled “Artificial Intervertebral Disc Having Limited Rotation Using A Captured Ball And Socket Joint With A Retaining Cap And A Solid Ball Having A Protrusion” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/294,985, entitled “Artificial Intervertebral Disc Having Limited Rotation Using A Captured Ball and Socket Joint With A Compression” and filed Ser. No. 10/294,985; U.S. patent application Ser. No. 10/294,980, entitled “Artificial Intervertebral Disc Having Limited Rotation Using A Captured Ball And Socket Joint With A Solid Ball, A Retaining Cap, And An Interference Pin” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/294,986, entitled “Artificial Intervertebral Disc Having Limited Rotation Using A Captured Ball and Socket Joint With A Solid Ball, A Compression Locking Post, And An Interference Pin” and filed Nov. 14, 2002; U.S. patent application Ser. No. 10/282,356, entitled “Artificial Intervertebral Disc” and filed Sep. 26, 2002; U.S. patent application Ser. No. 10/784,646, entitled Artificial Intervertebral Disc Trial Having A Controllably Separable Distal End” and filed Feb. 23, 2004; U.S. patent application Ser. No. 10/309,585, entitled “Static Trials And Related Instruments and Methods For Use In Implanting An Artificial Intervertebral Disc” and filed Dec. 4, 2002; U.S. patent application Ser. No. 10/784,637, entitled “Instrumentation For Properly Seating An Artificial Disc In An Intervertebral Space” and filed Feb. 23, 2004; U.S. patent application Ser. No. 10/783,153, entitled “Parallel Distractor And Related Methods For Use In Implanting An Artificial Intervertebral Disc” and filed Feb. 20, 2004, the disclosures of which are hereby incorporated by reference herein.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2774350 | Cleveland, Jr. | Dec 1956 | A |
| 3486505 | Morrison | Dec 1969 | A |
| 4733657 | Kluger | Mar 1988 | A |
| 4759766 | Buettner-Janz et al. | Jul 1988 | A |
| 4917704 | Frey et al. | Apr 1990 | A |
| 4955908 | Frey et al. | Sep 1990 | A |
| 4997432 | Keller | Mar 1991 | A |
| 5002576 | Fuhrmann et al. | Mar 1991 | A |
| 5059194 | Michelson | Oct 1991 | A |
| 5092866 | Breard et al. | Mar 1992 | A |
| 5122130 | Keller et al. | Jun 1992 | A |
| 5147366 | Arroyo et al. | Sep 1992 | A |
| 5192327 | Brantigan | Mar 1993 | A |
| 5236460 | Barber | Aug 1993 | A |
| 5246458 | Graham | Sep 1993 | A |
| 5258031 | Salib et al. | Nov 1993 | A |
| 5314477 | Marnay | May 1994 | A |
| 5401269 | Buttner-Janz et al. | Mar 1995 | A |
| 5425773 | Boyd et al. | Jun 1995 | A |
| 5431658 | Moskovich | Jul 1995 | A |
| 5443514 | Steffee | Aug 1995 | A |
| 5458641 | Ramirez Jimenez et al. | Oct 1995 | A |
| 5507816 | Bullivant et al. | Apr 1996 | A |
| 5556431 | Buttner-Janz | Sep 1996 | A |
| 5562738 | Boyd et al. | Oct 1996 | A |
| 5578052 | Koros et al. | Nov 1996 | A |
| 5597384 | Walker et al. | Jan 1997 | A |
| 5645605 | Klawitter | Jul 1997 | A |
| 5657429 | Wang et al. | Aug 1997 | A |
| 5674232 | Halliburton | Oct 1997 | A |
| 5674296 | Bryan et al. | Oct 1997 | A |
| 5676701 | Yuan et al. | Oct 1997 | A |
| 5683464 | Wagner et al. | Nov 1997 | A |
| 5720751 | Jackson | Feb 1998 | A |
| 5732992 | Mauldin | Mar 1998 | A |
| 5755796 | Ibo et al. | May 1998 | A |
| 5865846 | Bryan et al. | Feb 1999 | A |
| 5888223 | Bray, Jr. | Mar 1999 | A |
| 5888226 | Rogozinski | Mar 1999 | A |
| 5899941 | Nishijima | May 1999 | A |
| 5916267 | Tienboon | Jun 1999 | A |
| 6001130 | Bryan et al. | Dec 1999 | A |
| 6019792 | Cauthen | Feb 2000 | A |
| 6039763 | Shelokov | Mar 2000 | A |
| 6063121 | Xavier et al. | May 2000 | A |
| 6066174 | Farris | May 2000 | A |
| 6066175 | Henderson et al. | May 2000 | A |
| 6093205 | McLeod et al. | Jul 2000 | A |
| 6110179 | Flivik et al. | Aug 2000 | A |
| 6113637 | Gill et al. | Sep 2000 | A |
| 6113639 | Ray et al. | Sep 2000 | A |
| 6146421 | Gordon et al. | Nov 2000 | A |
| 6156067 | Bryan et al. | Dec 2000 | A |
| 6159214 | Michelson | Dec 2000 | A |
| 6159215 | Urbahns et al. | Dec 2000 | A |
| 6174311 | Branch et al. | Jan 2001 | B1 |
| 6179874 | Cauthen | Jan 2001 | B1 |
| 6190413 | Sutcliffe et al. | Feb 2001 | B1 |
| 6214005 | Benzel et al. | Apr 2001 | B1 |
| 6228118 | Gordon | May 2001 | B1 |
| 6241769 | Nicholson et al. | Jun 2001 | B1 |
| 6257098 | Cirone | Jul 2001 | B1 |
| 6261293 | Nicholson et al. | Jul 2001 | B1 |
| 6261296 | Aebi et al. | Jul 2001 | B1 |
| 6264659 | Ross et al. | Jul 2001 | B1 |
| 6290724 | Marino | Sep 2001 | B1 |
| 6296647 | Robioneck et al. | Oct 2001 | B1 |
| 6319257 | Carignan et al. | Nov 2001 | B1 |
| 6332887 | Knox | Dec 2001 | B1 |
| 6368350 | Erickson et al. | Apr 2002 | B1 |
| 6395030 | Songer et al. | May 2002 | B1 |
| 6395032 | Gauchet | May 2002 | B1 |
| 6416551 | Keller | Jul 2002 | B1 |
| 6425920 | Hamada | Jul 2002 | B1 |
| 6432106 | Fraser | Aug 2002 | B1 |
| 6440139 | Michelson | Aug 2002 | B2 |
| 6447517 | Bowman | Sep 2002 | B1 |
| 6461359 | Tribus et al. | Oct 2002 | B1 |
| 6478800 | Fraser et al. | Nov 2002 | B1 |
| 6517580 | Ramadan et al. | Feb 2003 | B1 |
| 6527804 | Gauchet et al. | Mar 2003 | B1 |
| 6540785 | Gill et al. | Apr 2003 | B1 |
| 6562073 | Foley | May 2003 | B2 |
| 6576017 | Foley et al. | Jun 2003 | B2 |
| 6579320 | Gauchet et al. | Jun 2003 | B1 |
| 6582466 | Gauchet et al. | Jun 2003 | B1 |
| 6582468 | Gauchet et al. | Jun 2003 | B1 |
| 6607559 | Ralph et al. | Aug 2003 | B2 |
| 6610093 | Pisharodi | Aug 2003 | B1 |
| 6656178 | Veldhuizen et al. | Dec 2003 | B1 |
| 6679915 | Cauthen | Jan 2004 | B1 |
| 6682562 | Viart et al. | Jan 2004 | B2 |
| 6706068 | Ferree | Mar 2004 | B2 |
| 6712825 | Aebi et al. | Mar 2004 | B2 |
| 6740087 | Knox | May 2004 | B2 |
| 6740118 | Eisermann et al. | May 2004 | B2 |
| 6755841 | Fraser et al. | Jun 2004 | B2 |
| 6770096 | Bolger et al. | Aug 2004 | B2 |
| 6840941 | Rogers et al. | Jan 2005 | B2 |
| 6863689 | Ralph et al. | Mar 2005 | B2 |
| 6896676 | Zubok et al. | May 2005 | B2 |
| 6908484 | Zubok et al. | Jun 2005 | B2 |
| 6966929 | Mitchell | Nov 2005 | B2 |
| 6972037 | Zubok et al. | Dec 2005 | B2 |
| 6972038 | Zubok et al. | Dec 2005 | B2 |
| 6989032 | Errico et al. | Jan 2006 | B2 |
| 6994728 | Zubok et al. | Feb 2006 | B2 |
| 6997954 | Zubok et al. | Feb 2006 | B2 |
| 6997955 | Zubok et al. | Feb 2006 | B2 |
| 7022139 | Errico et al. | Apr 2006 | B2 |
| 7044969 | Errico et al. | May 2006 | B2 |
| 7060098 | Errico et al. | Jun 2006 | B2 |
| 7066959 | Errico et al. | Jun 2006 | B2 |
| 7101399 | Errico et al. | Sep 2006 | B2 |
| 7115132 | Errico et al. | Oct 2006 | B2 |
| 7117765 | Wallden | Oct 2006 | B1 |
| 7118580 | Beyersdorff et al. | Oct 2006 | B1 |
| 7118599 | Errico et al. | Oct 2006 | B2 |
| 7141069 | Errico et al. | Nov 2006 | B2 |
| 7147642 | Grinberg et al. | Dec 2006 | B2 |
| 7153304 | Robie et al. | Dec 2006 | B2 |
| 7169182 | Errico et al. | Jan 2007 | B2 |
| 7198643 | Zubok et al. | Apr 2007 | B2 |
| 7204852 | Marnay et al. | Apr 2007 | B2 |
| 7217292 | Ralph et al. | May 2007 | B2 |
| 7226452 | Zubok et al. | Jun 2007 | B2 |
| 7235104 | Grinberg et al. | Jun 2007 | B2 |
| 7238203 | Bagga et al. | Jul 2007 | B2 |
| 7258699 | Errico et al. | Aug 2007 | B2 |
| 7300441 | Haid et al. | Nov 2007 | B2 |
| 7320689 | Keller | Jan 2008 | B2 |
| 7435845 | Dahlmann et al. | Oct 2008 | B2 |
| 7527629 | Link et al. | May 2009 | B2 |
| 7550008 | Ralph et al. | Jun 2009 | B2 |
| 7563285 | Ralph et al. | Jul 2009 | B2 |
| 7575600 | Zucherman et al. | Aug 2009 | B2 |
| 7604664 | Ralph et al. | Oct 2009 | B2 |
| 7811289 | Errico et al. | Oct 2010 | B2 |
| 7895724 | Dugan | Mar 2011 | B1 |
| 8777959 | Errico et al. | Jul 2014 | B2 |
| 9095451 | Errico et al. | Aug 2015 | B2 |
| 20010005796 | Zdeblick et al. | Jun 2001 | A1 |
| 20010010001 | Michelson | Jul 2001 | A1 |
| 20010027343 | Keller | Oct 2001 | A1 |
| 20020004683 | Michelson | Jan 2002 | A1 |
| 20020045899 | Errico et al. | Apr 2002 | A1 |
| 20020045904 | Fuss et al. | Apr 2002 | A1 |
| 20020058944 | Michelson | May 2002 | A1 |
| 20020082597 | Fraser | Jun 2002 | A1 |
| 20020082695 | Neumann | Jun 2002 | A1 |
| 20020082701 | Zdeblick et al. | Jun 2002 | A1 |
| 20020107571 | Foley | Aug 2002 | A1 |
| 20020107572 | Foley et al. | Aug 2002 | A1 |
| 20020116009 | Fraser et al. | Aug 2002 | A1 |
| 20020123750 | Eisermann et al. | Sep 2002 | A1 |
| 20020128715 | Bryan et al. | Sep 2002 | A1 |
| 20020143399 | Sutcliffe | Oct 2002 | A1 |
| 20020165549 | Owusu-Akyaw et al. | Nov 2002 | A1 |
| 20020169508 | Songer et al. | Nov 2002 | A1 |
| 20020193880 | Fraser | Dec 2002 | A1 |
| 20030004576 | Thalgott | Jan 2003 | A1 |
| 20030009226 | Graf | Jan 2003 | A1 |
| 20030023310 | Ralph et al. | Jan 2003 | A1 |
| 20030028197 | Hanson et al. | Feb 2003 | A1 |
| 20030032960 | Dudasik | Feb 2003 | A1 |
| 20030040796 | Ferree | Feb 2003 | A1 |
| 20030055503 | O'Neil | Mar 2003 | A1 |
| 20030069586 | Errico et al. | Apr 2003 | A1 |
| 20030069642 | Ralph et al. | Apr 2003 | A1 |
| 20030078668 | Michelson | Apr 2003 | A1 |
| 20030100949 | Michelson | May 2003 | A1 |
| 20030120344 | Michelson | Jun 2003 | A1 |
| 20030167091 | Scharf | Sep 2003 | A1 |
| 20030167092 | Foley | Sep 2003 | A1 |
| 20030181982 | Kuslich | Sep 2003 | A1 |
| 20030187453 | Schlapfer et al. | Oct 2003 | A1 |
| 20030187454 | Gill et al. | Oct 2003 | A1 |
| 20030199981 | Ferree | Oct 2003 | A1 |
| 20030199983 | Michelson | Oct 2003 | A1 |
| 20030204260 | Ferree | Oct 2003 | A1 |
| 20030208273 | Eisermann et al. | Nov 2003 | A1 |
| 20030208274 | Davis | Nov 2003 | A1 |
| 20030225416 | Bonvallet et al. | Dec 2003 | A1 |
| 20030229358 | Errico et al. | Dec 2003 | A1 |
| 20030229397 | Davis | Dec 2003 | A1 |
| 20030233097 | Ferree | Dec 2003 | A1 |
| 20030233145 | Landry et al. | Dec 2003 | A1 |
| 20030233148 | Ferree | Dec 2003 | A1 |
| 20030236524 | Squires et al. | Dec 2003 | A1 |
| 20040002712 | Grinberg et al. | Jan 2004 | A1 |
| 20040002758 | Landry et al. | Jan 2004 | A1 |
| 20040002759 | Ferree | Jan 2004 | A1 |
| 20040002761 | Rogers et al. | Jan 2004 | A1 |
| 20040002762 | Hawkins | Jan 2004 | A1 |
| 20040010254 | Cook et al. | Jan 2004 | A1 |
| 20040010316 | William et al. | Jan 2004 | A1 |
| 20040024459 | Ferree | Feb 2004 | A1 |
| 20040024461 | Ferree | Feb 2004 | A1 |
| 20040030387 | Landry et al. | Feb 2004 | A1 |
| 20040030389 | Ferree | Feb 2004 | A1 |
| 20040030390 | Ferree | Feb 2004 | A1 |
| 20040030391 | Ferree | Feb 2004 | A1 |
| 20040034420 | Errico et al. | Feb 2004 | A1 |
| 20040034421 | Errico et al. | Feb 2004 | A1 |
| 20040059318 | Zhang et al. | Mar 2004 | A1 |
| 20040073312 | Eisermann et al. | Apr 2004 | A1 |
| 20040106927 | Ruffner et al. | Jun 2004 | A1 |
| 20040117022 | Marnay et al. | Jun 2004 | A1 |
| 20040138750 | Mitchell | Jul 2004 | A1 |
| 20040143270 | Zucherman et al. | Jul 2004 | A1 |
| 20040143331 | Errico et al. | Jul 2004 | A1 |
| 20040143332 | Krueger et al. | Jul 2004 | A1 |
| 20040148028 | Ferree et al. | Jul 2004 | A1 |
| 20040167536 | Errico et al. | Aug 2004 | A1 |
| 20040176772 | Zubok et al. | Sep 2004 | A1 |
| 20040176773 | Zubok et al. | Sep 2004 | A1 |
| 20040176774 | Zubok et al. | Sep 2004 | A1 |
| 20040176777 | Zubok et al. | Sep 2004 | A1 |
| 20040176778 | Zubok et al. | Sep 2004 | A1 |
| 20040176843 | Zubok et al. | Sep 2004 | A1 |
| 20040176852 | Zubok et al. | Sep 2004 | A1 |
| 20040193272 | Zubok et al. | Sep 2004 | A1 |
| 20040215198 | Marnay et al. | Oct 2004 | A1 |
| 20040215203 | Michelson | Oct 2004 | A1 |
| 20040220567 | Eisermann et al. | Nov 2004 | A1 |
| 20040220582 | Keller | Nov 2004 | A1 |
| 20040220590 | Zubok et al. | Nov 2004 | A1 |
| 20040225295 | Zubok | Nov 2004 | A1 |
| 20040243240 | Beaurain et al. | Dec 2004 | A1 |
| 20040249388 | Michelson | Dec 2004 | A1 |
| 20050010213 | Stad et al. | Jan 2005 | A1 |
| 20050015094 | Keller | Jan 2005 | A1 |
| 20050015095 | Keller | Jan 2005 | A1 |
| 20050021040 | Bertagnoli | Jan 2005 | A1 |
| 20050021042 | Marnay et al. | Jan 2005 | A1 |
| 20050033428 | Keller | Feb 2005 | A1 |
| 20050043800 | Paul et al. | Feb 2005 | A1 |
| 20050055029 | Marik et al. | Mar 2005 | A1 |
| 20050055031 | Lim | Mar 2005 | A1 |
| 20050055098 | Zdeblick et al. | Mar 2005 | A1 |
| 20050065611 | Huppert et al. | Mar 2005 | A1 |
| 20050071013 | Zubok et al. | Mar 2005 | A1 |
| 20050113842 | Bertagnoli et al. | May 2005 | A1 |
| 20050113926 | Zucherman et al. | May 2005 | A1 |
| 20050119665 | Keller | Jun 2005 | A1 |
| 20050132847 | Garg | Jun 2005 | A1 |
| 20050143749 | Zalenski et al. | Jun 2005 | A1 |
| 20050159819 | McCormack et al. | Jul 2005 | A1 |
| 20050203533 | Ferguson et al. | Sep 2005 | A1 |
| 20050228500 | Kim et al. | Oct 2005 | A1 |
| 20050240270 | Zubok et al. | Oct 2005 | A1 |
| 20050240271 | Zubok et al. | Oct 2005 | A1 |
| 20050240272 | Zubok et al. | Oct 2005 | A1 |
| 20050251262 | De Villiers et al. | Nov 2005 | A1 |
| 20050256577 | Baumgartner et al. | Nov 2005 | A1 |
| 20050267581 | Marnay et al. | Dec 2005 | A1 |
| 20060004377 | Keller | Jan 2006 | A1 |
| 20060030860 | Peterman | Feb 2006 | A1 |
| 20060064100 | Bertagnoli et al. | Mar 2006 | A1 |
| 20060069439 | Zucherman et al. | Mar 2006 | A1 |
| 20060085077 | Cook et al. | Apr 2006 | A1 |
| 20060095046 | Trieu et al. | May 2006 | A1 |
| 20060100634 | Ferguson | May 2006 | A1 |
| 20060116768 | Krueger et al. | Jun 2006 | A1 |
| 20060149278 | Abdou | Jul 2006 | A1 |
| 20060167461 | Hawkins et al. | Jul 2006 | A1 |
| 20060195114 | Bertagnoli | Aug 2006 | A1 |
| 20060200166 | Hanson et al. | Sep 2006 | A1 |
| 20060217731 | Gil et al. | Sep 2006 | A1 |
| 20060235422 | Keller | Oct 2006 | A1 |
| 20060247645 | Wilcox et al. | Nov 2006 | A1 |
| 20060247649 | Rezach et al. | Nov 2006 | A1 |
| 20070073403 | Lombardo et al. | Mar 2007 | A1 |
| 20070073405 | Verhulst et al. | Mar 2007 | A1 |
| 20070093828 | Abdou | Apr 2007 | A1 |
| 20070118224 | Shah et al. | May 2007 | A1 |
| 20070123904 | Stad et al. | May 2007 | A1 |
| 20070123989 | Gfeller et al. | May 2007 | A1 |
| 20070191856 | Gil et al. | Aug 2007 | A1 |
| 20070225813 | Haines | Sep 2007 | A1 |
| 20070282448 | Abdou | Dec 2007 | A1 |
| 20080077155 | Diederich et al. | Mar 2008 | A1 |
| 20080082169 | Gittings et al. | Apr 2008 | A1 |
| 20080161921 | Carls et al. | Jul 2008 | A1 |
| 20090018663 | Cook et al. | Jan 2009 | A1 |
| 20090030421 | Hawkins et al. | Jan 2009 | A1 |
| 20090182341 | Link et al. | Jul 2009 | A1 |
| Number | Date | Country |
|---|---|---|
| 19903763 | Aug 2000 | DE |
| 10005880 | Aug 2001 | DE |
| 1222903 | Jul 2002 | EP |
| 1488747 | Dec 2004 | EP |
| 2005-052652 | Mar 2005 | JP |
| 9113598 | Sep 1991 | WO |
| 0162191 | Aug 2001 | WO |
| 0236024 | May 2002 | WO |
| 2003077808 | Sep 2003 | WO |
| 04041131 | May 2004 | WO |
| Entry |
|---|
| Office Action from Japanese Application No. 2008-513755 dated Dec. 21, 2010. |
| Extended European Search Report for application No. EP13156631 dated Jul. 17, 2013. |
| Number | Date | Country | |
|---|---|---|---|
| 20180008431 A1 | Jan 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60790415 | Apr 2006 | US | |
| 60721053 | Sep 2005 | US | |
| 60701306 | Jul 2005 | US | |
| 60685295 | May 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11439808 | May 2006 | US |
| Child | 14153514 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14956844 | Dec 2015 | US |
| Child | 15700776 | US | |
| Parent | 14746347 | Jun 2015 | US |
| Child | 14956844 | US | |
| Parent | 14153514 | Jan 2014 | US |
| Child | 14746347 | US |
