Lateral Spondylolisthesis Reduction Cage
20220000637 · 2022-01-06
Inventors
- Michael J. O'Neil (West Barnstable, MA, US)
- Hassan Serhan (South Easton, MA, US)
- Douglas Raymond (Bridgewater, MA, US)
- John Riley Hawkins (Cumberland, RI, US)
Cpc classification
A61F2/447
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2/30771
HUMAN NECESSITIES
A61F2002/443
HUMAN NECESSITIES
A61B2017/3433
HUMAN NECESSITIES
A61F2/4465
HUMAN NECESSITIES
A61F2/446
HUMAN NECESSITIES
A61F2/4603
HUMAN NECESSITIES
International classification
A61B17/16
HUMAN NECESSITIES
A61B17/17
HUMAN NECESSITIES
Abstract
An intervertebral fusion device comprising inferior and superior fusion cage devices that provide an ability to correct spondylolisthesis via in-situ adjustment.
Claims
1-48. (canceled)
49. An intervertebral fusion device, comprising: an upper plate defining an upper vertebral engagement surface that is configured to contact an upper vertebral body; a lower plate defining a lower vertebral engagement surface that is configured to contact a lower vertebral body, wherein the expandable intervertebral fusion device is expandable from a collapsed configuration whereby the upper and lower plates are spaced from each other a first distance to an expanded configuration whereby the upper and lower plates are spaced from each other a second distance greater than the first distance; and a linkage that is pivotally coupled to each of the upper plate and the lower plate when the intervertebral fusion device is in the collapsed configuration, as the intervertebral fusion device expands from the collapsed configuration to the expanded configuration, and when the intervertebral fusion device is in the expanded configuration, wherein the lower plate includes a pair of lower projections that extend toward the upper plate and define a gap therebetween, the upper plate defines an upper projection that is disposed in the gap when the intervertebral fusion device is in the collapsed configuration, and the upper projection is removed from the gap when the intervertebral fusion device is in the expanded configuration.
50. The intervertebral fusion device of claim 49, wherein the upper and lower plates are lordotic when the intervertebral fusion device is in the expanded configuration.
51. The intervertebral fusion device of claim 49, wherein the linkage is disposed proximate a leading end of the intervertebral fusion device into a disc space that is defined by the upper and lower vertebral bodies.
52. The intervertebral fusion device of claim 49, wherein the linkage comprises a first linkage, and the intervertebral fusion device further comprises a second linkage that is pivotally coupled to each of the upper plate and the lower plate when the intervertebral fusion device is in the collapsed configuration, as the intervertebral fusion device expands from the collapsed configuration to the expanded configuration, and when the intervertebral fusion device is in the expanded configuration.
53. The intervertebral fusion device of claim 52, wherein the first and second linkages are disposed on opposite sides of the intervertebral fusion device.
54. The intervertebral fusion device of claim 53, wherein the intervertebral fusion device is configured to be inserted into an intervertebral space along an insertion direction, and an axis elongate along the insertion direction is disposed between the opposed sides.
55. The intervertebral fusion device of claim 52, wherein the first and second linkages are aligned with each other along a direction perpendicular to a direction of insertion of the intervertebral fusion device into a disc space.
56. The intervertebral fusion device of claim 49, further comprising a throughhole that extends through the upper plate to promote fusion.
57. The intervertebral fusion device of claim 49, wherein the linkage rotates as the intervertebral fusion device expands from the collapsed configuration to the expanded configuration.
58. The intervertebral fusion device of claim 49, wherein the linkage is elongate along an axis, and the axis angulates toward a vertical orientation as the intervertebral fusion device expands from the collapsed configuration to the expanded configuration.
59. The intervertebral fusion device of claim 49, wherein the linkage extends along respective exterior side surfaces of the upper and lower plates.
60. The intervertebral fusion device of claim 49, wherein the intervertebral fusion device is expandable along a vertical direction from the collapsed configuration to the expanded configuration, the upper plate defines a lower surface opposite the upper vertebral engagement surface, the lower plate defines an upper surface opposite the lower vertebral engagement surface, and the lower surface of the upper plate move relative to each other along a direction perpendicular to the vertical direction as the intervertebral fusion device expands from the collapsed configuration to the expanded configuration.
61. The intervertebral fusion device of claim 49, wherein the linkage allows the upper plate to pivot relative to the lower plate in a plane defined by a side wall of the lower plate, wherein the side wall extends from a leading end to a trailing end of the lower plate with respect to a direction of insertion of the intervertebral fusion device into a disc space.
Description
DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0048]
[0049] In use, the devices of the present invention accomplish improved and controlled spondylolisthesis correction with fusion from the lateral approach. The lateral cage devices of the present invention also provide for intra-operative trialing and selection to enhance conformance of the cage geometry to the vertebral body endplates bounding the targeted disc space. The fusion device of the present invention provides for direct attachment of its superior and inferior cages to the lateral aspects of the opposing vertebral bodies.
[0050] Several devices and methods for correcting spondylolisthesis with fusion from the lateral approach are disclosed. All incorporate a superior and inferior fusion cages that are fixedly attached to the corresponding vertebral bodies. The fixed attachment can be accomplished by using pre-attached plates, or by incorporating internal screws (e.g., the STALIF approach) and/or lateral keels. Following implantation, the superior and inferior cages are aligned in-situ via various activation means that are further discussed below, and then locked in place.
[0051] The interior, contacting surfaces of the cages that effect intra-device attachment contain alignment and securement features that allow for controlled intra-operative manipulation of the spine in the sagittal plane following individual fixed attachment of the cages to the superior and inferior vertebral bodies. These features can include but are not limited to teeth, barbs, and dovetails.
[0052] Both the superior and inferior cages can include features on their outer surfaces that can enhance securement to the vertebral body endplate. These features include fins, barbs, teeth, osteoconductive surface morphology (porosity) and coatings (such as HA and TCP). The superior and inferior cages can also include graft-retention windows and pockets to facilitate the long-term fusion of the two vertebral bodies of the functional spinal unit.
[0053] The inner contacting surfaces of the cage can be flat to allow for the incremental lineal adjustment of the relative cage positions. Alternatively, these surfaces can be domed so as to enable the accurate adjustment of the vertebral bodies to a centered position in the flexion/extension plane (i.e., to the center of rotation).
[0054] The external geometry of the superior and inferior cages can be flat or lordotic, and can be domed or angled in various plans to enhance their conformance to the vertebral body endplates and to address spinal deformity and/or scoliosis.
[0055] Following fixed attachment to the vertebral body, the superior and inferior cages may be aligned by several means, including the following:
[0056]
[0057]
[0058] As shown in
[0059] As shown in
[0060] Now referring to
[0063] In some embodiments, the lower surface of the upper plate and the upper surface of the lower cage include tongue-and-groove feature. Preferably, the tongue-and-groove feature runs from about the anterior wall to about the posterior wall. Preferably, the tongue-and-groove feature comprises an expanding recess 29 and more preferably comprises a dovetail 31.
[0064] In some embodiments, the lower surface of the upper cage and the upper surface of the lower cage include a ridge and recess feature 33 that runs in a proximal-distal direction.
[0065] In some embodiments, the proximal wall of the upper cage has a height Hu-p, the anterior wall of the upper cage has a height Hu-a, and wherein the height of the proximal wall of the upper cage is greater than the height of the anterior wall of the upper cage.
[0066] In some embodiments, the proximal wall of the upper cage has an upper portion 35 having a upper through-hole 37 located above the anterior wall and adapted for receiving a bone screw.
[0067] In some embodiments, the proximal wall of the lower cage has a height Hl-p, the anterior wall of the lower cage has a height Hl-a, and wherein the height of the proximal wall of the lower cage is greater than the height of the anterior wall of the lower cage.
[0068] In some embodiments, the proximal wall of the lower cage has a lower portion 39 having a lower through-hole 41 located beneath the anterior wall and adapted for receiving a bone screw.
[0069] In some locking plate embodiments, the proximal wall of the upper cage has a lower portion 43 having an lower through-hole 45 located beneath the anterior wall of the upper cage and adapted for receiving a screw. Likewise, the proximal wall of the lower cage has an upper portion 47 having an upper through-hole 49 located above the anterior wall of the lower cage and adapted for receiving a bone fastener such as a screw. The device further comprises: [0070] c) a locking plate 51 having a first and second throughholes 53, and [0071] d) first and second bone fasteners (such as screws) 55, wherein the locking plate is fixed to the proximal wall of the upper and lower cages by passing the first bone fastener through the first throughhole of the locking plate and into the lower throughhole of the upper cage, and by passing the second bone fastener through the second throughhole of the locking plate and into the upper throughhole of the lower cage.
[0072] In some embodiments that promote fusion, the upper cage further comprises a lower surface 13 and a throughole 59 running from the upper surface to the lower surface. In some embodiments that promote fusion, the lower cage further comprises an upper surface and a throughole running from the upper surface to the lower surface. Likewise, the anterior wall further comprises a throughole 61 running therethrough. These throughholes are of a size adapted to promote fusion
[0073] In some embodiments, the distal end wall of each of the upper and lower cages has a taper 63 for ease of insertion.
[0074] In the first embodiment, and now referring to
[0075]
[0076] Now referring to
[0077] Therefore, in accordance with the present invention, there is provided (claim 16) a method for correcting spondylolisthesis in a patient, comprising the steps of: [0078] a) selecting a fusion device comprising an upper cage and a lower cage, [0079] b) fixing the upper cage to an upper vertebral body of the patient and the lower cage to a lower vertebral body of the patient, [0080] c) moving the upper cage relative to the lower cage to correct the spondylolisthesis.
[0081] Preferably, the method further comprises the step of: d) locking the upper cage to the lower cage.
[0082] In some embodiments, the locking step is accomplished by a locking plate. In some embodiments, the moving step is accomplished with a compression-directed inserter.
[0083] In some embodiments, the moving step is accomplished with a rotary spreader.
[0084] In a second embodiment, and now referring to
[0085] Now referring to
[0086] In some embodiments, and now referring to
[0087] Now referring to
wherein the lower surface of the upper cage contacts the upper surface of the lower cage so that the first and second grooves form a first throughhole 107 running from the proximal wall to about the distal wall,
wherein the locking plate is disposed in the first throughole.
[0091] In some embodiments, the first groove is present upon the lower surface of the anterior wall of the upper cage, and the second groove is present upon the upper surface of the anterior wall of the lower cage. In other embodiments, the first groove is present upon the lower surface of the posterior wall of the upper cage, and the second groove is present upon the upper surface of the posterior wall of the lower cage.
[0092] In some embodiments, the device of the second embodiment further comprises a third groove 109 present upon the lower surface of the upper cage between the anterior and posterior walls, and a fourth groove 111 present upon the upper surface of the lower cage between the anterior and posterior walls, and wherein the lower surface of the upper cage contacts the upper surface of the lower plate so that the third and fourth grooves form a second throughhole 113 running from the proximal wall to about the distal wall, the second throughhole adapted for insertion of a spreader therein.
[0093] In a third embodiment, and now referring to
[0094] In some embodiments, and now referring to
[0095] In some embodiments, and now referring to
[0096] Now referring to
[0097] Now referring to
wherein the anterior wall is connected to the proximal wall by a first dual linkage 145 and to the distal wall by a second dual linkage (not shown),
wherein the posterior wall is connected to the proximal wall by a third dual linkage 149 and to the distal wall by a fourth dual linkage (not shown),
wherein the linkages allow the upper plate to pivot relative to the lower plate in the plane of the proximal wall.
[0100] In some aspects of this third embodiment, the proximal wall of the upper cage has a height, the anterior wall of the upper cage has a height, and wherein the height of the proximal wall of the upper cage is greater than the height of the anterior wall of the upper cage. In some embodiments thereof, the proximal wall of the upper cage has an upper portion 153 having a upper through-hole 155 located above the anterior wall and adapted for receiving a bone screw.
[0101] In other aspects of this third embodiment, the proximal wall of the lower cage has a height, the anterior wall of the lower cage has a height, and wherein the height of the proximal wall of the lower cage is greater than the height of the anterior wall of the lower cage. In some embodiments thereof, the proximal wall of the lower cage has a lower portion 157 having a lower through-hole 159 located beneath the anterior wall and adapted for receiving a bone screw.
[0102] In some embodiments, the upper cage has a throughole 161 running from the upper surface to the lower surface. This throughhole is adapted for promoting fusion
[0103] In a fourth embodiment, the alignment means includes a rack-and-pinion. A pinion located between the upper and lower walls and extending laterally can be rotated to move racks extending in the anterior-posterior direction and thereby reduce spondylolisthesis.
[0104] Now referring to
wherein the pinion 191 extends substantially from the distal wall to the proximal wall,
wherein the rack 193 extends substantially from the anterior wall to the posterior wall,
so that rotation of the pinion effects relative movement of the upper and lower walls in the anterior-posterior direction.
[0110] In some aspects of the fourth embodiment, the length of the device is at least three times the height of the device.
[0111] In some embodiments, the upper and lower walls each have at least one hole 195 therethrough to facilitate fusion through the device. In others, the anterior and posterior walls each have at least one hole 197 therethrough to facilitate fusion through the device.
[0112] In some embodiments, the rack extends from the inner surface of the upper wall. In others, the rack extends from the inner surface of the lower wall.
[0113] In some embodiments, the pinion comprises a proximal end 199 having a feature 201 for receiving a rotary tool.
[0114] In some embodiments, at least one of the anterior and posterior walls is integral with at least one of the upper and lower walls.
[0115] In some embodiments, at least one of the anterior and posterior walls is removable.
[0116] The embodiments of the present invention may optionally a securement plate that attaches to both the device of the present invention and the vertebral bodies. This securement plate secures the position of the device and provides supplemental stabilization.
[0117] In general, the devices of the present invention are suited for substantially lateral insertion into the disc space. In some embodiments, the cages are inserted through a more anterolateral insertion angle.
[0118] Now referring to
[0119] In some embodiments, as in
[0120] The lateral spondylolisthesis reduction fusion devices of the present invention may be produced from a single material or from multiple materials. These materials include metallics (such as Ti, Ti alloys such as nitinol, stainless steel, and cobalt-chrome), polymeric materials (including PEEK, PEAK, polypropylene, polyethylene terephthalate (PET), UHMWPE), biologic materials (including allograft, hydroxyapatite, TCP and CaPO.sub.4), and ceramic materials including silicon nitrides, and zirconia-containing ceramics. The plate, fasteners, or locking mechanisms can be produced from metallics or polymers for enhance durability.
[0121] Additionally, modified versions of this concept can be designed to correct spondylolisthesis with superior and inferior cages that are inserted from the anterior, anterior-lateral or posterior approaches.
[0122] The cages of the present invention are preferably inserted either from a right lateral or left lateral approach.
[0123] Following standard access and disc preparation procedures, the superior and inferior cages are inserted and affixed to the opposed vertebral bodies with screws or bone fasteners. Spondylolisthesis correction is then performed with the disclosed compressor or with a rotary tool. Optionally, locking members are then applied to the superior and inferior cages to fix the orientation of the segments.
[0124] Also in accordance with the present invention, there is provided a method of implanting an intervertebral device between opposed vertebral bodies, comprising the steps of: [0125] i) selecting an intervertebral device comprising: [0126] a. an upper half component having an anterior wall, a posterior wall, and two side walls connecting the anterior wall and posterior wall; [0127] b. a lower half component having an anterior wall, a posterior wall, and two side walls connecting the anterior wall and posterior wall; [0128] ii) inserting the device between opposed vertebral bodies, whereby the anterior walls are not aligned, [0129] iii) moving (preferably by pivoting) one of the components with respect to the other component so that the anterior walls are substantially aligned, and [0130] iv) fixing the device to the opposed vertebral bodies;
[0131] In some embodiments of the present invention, the fusion device is angled to provide either lordosis or kyphosis. In embodiments in which lordosis is desired, the height of the anterior wall exceeds the height of the posterior wall. An example of such a lordotic implant is shown in
[0132] It is believed by the present inventors that the devices disclosed herein appear to be the first intervertebral devices having a flange that connects to a side of a vertebral body. Therefore, in accordance with the present invention, there is provided a method of inserting a fusion device between opposed vertebral bodies, comprising the steps of: [0133] a) selecting an intervertebral device having an anterior wall, a posterior wall and a pair of side walls connecting the anterior and posterior walls, wherein at least one of the side walls has a flange axially extending beyond the anterior wall and the posterior wall, wherein the flange has a throughhole, [0134] b) inserting the device between the opposed vertebral bodies, and [0135] c) inserting a fixation device through the throughhole to fix the device to a side of one of the opposed vertebral bodies.
[0136] Although the cages of the present invention are disclosed as having flanges that extend beyond the disc space for attachment to the sides of the opposed vertebral bodies, it is also contemplated that the cages of the present invention may be attached to the opposed vertebral bodies via zero profile throughholes. These zero profile throughholes are provided both a) at the upper edge of the proximal side wall of the upper half component and b) at the lower edge of the proximal side wall of the lower half component.
[0137] Therefore, in accordance with the present invention, there is provided an intervertebral fusion device for correcting spondylolisthesis in a patient, comprising: [0138] a) an upper cage having an anterior wall, a posterior wall, and a proximal wall and a distal wall connecting the anterior and posterior walls, and a throughole present at the upper edge of the proximal wall for receiving a bone fixation device, [0139] b) a lower cage having an anterior wall, a posterior wall, and a proximal wall and a distal wall connecting the anterior and posterior walls, and a lower surface for contacting a lower vertebral body and an upper surface, and a throughole present at the lower edge of the proximal wall for receiving a bone fixation device,
wherein the lower surface of the upper cage slidingly mates with upper surface of the lower cage.
[0140] Although the above description discloses how to make and use implantable devices to correct spondylolisthesis, it is within the scope of the invention to use these devices as instruments to correct retrolisthesis as well. Therefore, in accordance with the present invention, there is provided a method for correcting spondylolisthesis in a patient, comprising the steps of: [0141] a) selecting an instrument comprising an upper cage and a lower cage, wherein each cage is attached to a handle [0142] b) attaching the upper cage to an upper vertebral body of the patient and the lower cage to a lower vertebral body of the patient (preferably with caspar pins), [0143] c) moving the upper cage relative to the lower cage to correct the spondylolisthesis (preferably with a distractor that engages the caspar pins), and [0144] d) removing the instrument from the patient.
[0145] Although the above description discloses how to make and use devices in the context of correcting spondylolisthesis, it is within the scope of the invention to use similar devices to correct retrolisthesis as well.
[0146]
[0147]
[0148] The cross section of the beams are sufficiently wide in the anterior-posterior direction making them resistant to bending in the transverse plane. The mechanism within the handle is to pivot the beams. This can be done with a ratchet and pawl linkage which moves the top beam one click with each squeeze, or a sliding collar that advances distally along the beams to bring them in line with each other, or a wedge/roller that advances along the edge of the superior beam or a post and angled slot mechanism that aligns the two beams, or with a geared scissor mechanism such that the full motion of the handle corresponds to a small angular change of the beams. The controlled motion of the beams relative to each other is advantageous as the operating surgeon generally has a pre-determined amount of reduction in mind for the surgery. This amount can be determined via radiograph or inter-operatively. For example if a total of 6 mm of reduction is desired, the handle can be ratcheted 1 mm at a time until the value of 6 mm is reached.
Therefore, there is provided a spondylolisthesis reduction tool comprising: [0149] a) a proximal handle portion, and [0150] b) first and second vertebral body-engaging beams having a longitudinal axis, a proximal end portion and a distal end portion, the distal end portion of each beam forming bone engaging features,
wherein the proximal end portion of the first beams is fixedly attached to the handle portion, and
wherein the proximal end portion of the second beam is pivotally attached to the handle portion so that the second beam can move transversely with respect to the longitudinal axis of the first beam.
Preferably, the handle portion comprises a trigger 311 adapted to pivotally move the second beam.