Low profile intervertebral implant
10543102 ยท 2020-01-28
Assignee
Inventors
- Thomas Kueenzi (Magden, CH)
- Ryan T. Walsh (Douglassville, PA, US)
- Thomas Pepe (West Chester, PA, US)
- Markus Hunziker (Aaru, CH)
- David Koch (North Logan, UT, US)
Cpc classification
A61F2002/30578
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
A61F2002/30787
HUMAN NECESSITIES
A61F2002/30092
HUMAN NECESSITIES
A61F2210/0014
HUMAN NECESSITIES
A61B17/86
HUMAN NECESSITIES
A61B17/8033
HUMAN NECESSITIES
A61F2220/0033
HUMAN NECESSITIES
A61F2002/30331
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2002/30507
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
International classification
Abstract
The present invention is directed to a low profile intervertebral implant for implantation in an intervertebral disc space in-between adjacent vertebral bodies. The intervertebral implant includes a plate preferably coupled to a spacer. The plate is preferably formed from a first material and the spacer is preferably formed from a second material, the first material being different from the second material. The plate is preferably sized and configured so that the plate does not extend beyond the perimeter of the spacer. In this manner, the plate preferably does not increase the height profile of the spacer and the plate may be implanted within the intervertebral disc space in conjunction with the spacer.
Claims
1. A plate configured to be coupled to a spacer to form an intervertebral implant that is insertable into an intervertebral disc space defined by a first vertebral body and a second vertebral body, the plate comprising: a body portion including a first surface and a second surface offset from the first surface in a first direction, the body portion defining a first hole having a first entry opening with an enclosed shape defined by the first surface and a first exit opening defined at least partially by the second surface, at least a portion of the first exit opening offset from the first entry opening with respect to a second direction that is oblique to the first direction such that the first hole is configured to receive a bone fixation element that secures the plate to one of the first vertebral body and the second vertebral body, the body portion defining a second hole having a second entry opening with an enclosed shape defined by the first surface and a second exit opening defined at least partially by the second surface, at least a portion of the second exit opening offset from the second entry opening with respect to a third direction that is oblique to the first direction such that the second hole is configured to receive a bone fixation element that secures the plate to the other of the first vertebral body and the second vertebral body, the body portion further including a top surface and a bottom surface, the bottom surface offset from the top surface in a fourth direction that is perpendicular to the first direction, the top surface configured to abut the first vertebral body when the intervertebral implant is inserted into the intervertebral disc space, and the bottom surface configured to abut the second vertebral body when the intervertebral implant is inserted into the intervertebral disc space, wherein an entirety of both the first entry opening and the second entry opening are positioned between the top surface and the bottom surface; a first arm that extends from the body portion and terminates at a first end such that a portion of the first arm is offset from the second surface in the first direction, the portion of the first arm including a first arm top surface and a first arm bottom surface offset from the first arm top surface in the fourth direction, wherein the first end comprises a first plurality of teeth that are linearly arranged and disposed between the top and bottom surfaces of the body portion; and a second arm that extends from the body portion and terminates at a second end such that a portion of the second arm is offset from the second surface in the first direction, and the second end comprises a second plurality of teeth that face the first plurality of teeth, are linearly arranged, and are disposed between the top and bottom surfaces of the body portion, wherein respective terminal surfaces of the first and second ends are spaced from each other by a distance measured in a fifth direction that is perpendicular to both the first direction and the fourth direction, wherein the first arm and the second arm are sized and configured to securely receive and couple the spacer to the plate, the body portion defines a first height measured from the top surface of the body portion to the bottom surface of the body portion in the fourth direction, the portion of the first arm defines a second height measured from the first arm top surface to the first arm bottom surface in the fourth direction, and the first height is greater than the second height, and wherein at least a portion of the first entry opening is aligned with at least a portion of the second entry opening with respect to the fifth direction.
2. The plate of claim 1, wherein the first height is measured along the first surface, the first arm extends from the second surface in the first direction, the first arm projects inward toward the second arm so as to define the first end of the first arm, and the second height is measured at the first end of the first arm.
3. The plate of claim 1, wherein the first height is a maximum height of the body portion, and the second height is a minimum height of the first arm.
4. The plate of claim 3, wherein the portion of the second arm includes a second arm top surface and a second arm bottom surface offset from the second arm top surface in the fourth direction, the portion of the second arm defines a third height measured from the second arm top surface to the second arm bottom surface in the fourth direction, and the first height is greater than the third height.
5. The plate of claim 4, wherein when the plate is coupled to the spacer, the intervertebral implant is configured to be inserted in the intervertebral disc space such that the second arm top surface faces the first vertebral body and the second arm bottom surface faces the second vertebral body.
6. The plate of claim 5, wherein when the plate is coupled to the spacer, the intervertebral implant is configured to be inserted in the intervertebral disc space such that the second arm top surface abuts the first vertebral body and the second arm bottom abuts the second vertebral body.
7. The plate of claim 5, wherein the second height is equal to the third height.
8. The plate of claim 5, wherein the third height is a minimum height of the second arm.
9. The plate of claim 5, wherein the top surface, the first arm top surface, and the second arm top surface each are configured to face the first vertebral body when the plate is coupled to the spacer and the intervertebral implant is inserted in the intervertebral disc space, and the bottom surface, the first arm bottom surface, and the second arm bottom surface each are configured to face the second vertebral body when the plate is coupled to the spacer and the intervertebral implant is inserted in the intervertebral disc space.
10. The plate of claim 5, wherein the first arm includes a first sidewall and a second sidewall that is opposite the first sidewall, the second arm includes a first sidewall that faces the first sidewall of the first arm, the second arm further includes a second sidewall opposite the first sidewall of the second arm, and the second sidewall of the first arm converges toward the second sidewall of the second arm as the first arm extends in the first direction.
11. The plate of claim 5, wherein both the portion of the first arm and the portion of the second arm are offset from the first exit opening in the first direction.
12. The plate of claim 1, wherein the second height is measured from a first location on the first arm top surface to a second location on the first arm bottom surface, and the first arm top surface is parallel to the first arm bottom surface.
13. A plate configured to be coupled to a spacer to form an intervertebral implant that is configured to be inserted in an intervertebral disc space that is defined by a first vertebral body and a second vertebral body, the plate comprising: a body portion including a first surface and a second surface offset from the first surface in a first direction, the body portion defining a first hole having a first entry opening with an enclosed shape defined by the first surface and a first exit opening, at least a portion of the first exit opening offset from the first entry opening with respect to a second direction that is oblique to the first direction such that the first hole is configured to receive a bone fixation element that secures the plate to the first vertebral body, the body portion defining a second hole having a second entry opening with an enclosed shape defined by the first surface and a second exit opening, at least a portion of the second exit opening offset from the second entry opening with respect to a third direction that is oblique to the first direction such that the second hole is configured to receive a bone fixation element that secures the plate to the second vertebral body, the body portion further including a top surface and a bottom surface offset from the top surface in a fourth direction that is perpendicular to the first direction, the top surface configured to face the first vertebral body when the plate is inserted in the intervertebral disc space, the bottom surface configured to face the second vertebral body when the plate is inserted in the intervertebral disc space, wherein a portion of the first entry opening is closer to the top surface than an entirety of the second entry opening is to the top surface; a first arm attached to the body portion such that the first arm extends from the second surface in the first direction and terminates at a first end, the first arm including a first portion and a second portion offset from each other along the first direction, the first portion including a first top arm surface and a first bottom arm surface offset from the first top arm surface in the fourth direction, the second portion including a second top arm surface and a second bottom arm surface offset from the second top arm surface in the fourth direction, the first arm configured such that when the plate is inserted in the intervertebral disc space the first top arm surface and the second top arm surface each face the first vertebral body and the first bottom arm surface and the second bottom arm surface each face the second vertebral body; and a second arm that extends from the body portion and terminates at a second end, such that respective end surfaces of the first and second ends are separated from each other by a distance measured in a fifth direction that is perpendicular to both the first direction and the fourth direction, wherein the first end and the second end comprise respective linear arrays of teeth that face each other and are disposed between the top surface and the bottom surface of the body portion, wherein the first portion defines a first height measured from the first top arm surface to the first bottom arm surface in the fourth direction, the second portion defines a second height measured from the second top arm surface to the second bottom arm surface in the fourth direction, and the first height is greater than the second height, and wherein at least a portion of the first entry opening is aligned with at least a portion of the second entry opening with respect to the fifth direction.
14. The plate of claim 13, wherein both the first portion and the second portion are offset from the exit opening in the first direction.
15. The plate of claim 13, wherein the body portion defines a third height measured from the top surface to the bottom surface in the fourth direction, and the third height is greater than the second height.
16. The plate of claim 13, wherein the second arm is offset from the first arm by a gap that is configured to receive the spacer.
17. The plate of claim 13, wherein the second arm includes a third portion and a fourth portion offset from each other along the first direction, the third portion including a third top arm surface and a fourth bottom surface offset from the third top arm surface in the fourth direction, the fourth portion including a fourth top arm surface and a fourth bottom surface offset from the fourth top arm surface in the fourth direction, the second arm configured such that when the plate is inserted in the intervertebral disc space the third top arm surface and the fourth top arm surface each face the first vertebral body and the third bottom surface and the fourth bottom surface each face the second vertebral body.
18. The plate of claim 17, wherein the third portion defines a third height measured from the third top arm surface to the third bottom surface in the fourth direction, the fourth portion defines a fourth height measured from the fourth top arm surface to the fourth bottom surface in the fourth direction, and the third height is greater than the fourth height.
19. The plate of claim 18, wherein the body portion defines a fifth height measured from the top surface to the bottom surface in the fourth direction, the fifth height is greater than the second height, and the fifth height is greater than the fourth height.
20. The plate of claim 18, wherein each of the first portion, the second portion, the third portion, and the fourth portion are offset from the exit opening in the first direction.
21. The plate of claim 18, wherein the first arm includes a first sidewall and a second sidewall that is opposite the first sidewall, the second arm includes a first sidewall that faces the first sidewall of the first arm, the second arm further includes a second sidewall opposite the first sidewall of the second arm, and the second sidewall of the first arm converges toward the second sidewall of the second arm as the first arm extends in the first direction.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The foregoing summary, as well as the following detailed description of the preferred embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the preferred intervertebral implants of the present application, there is shown in the drawings preferred embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:
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DETAILED DESCRIPTION OF THE INVENTION
(18) Certain terminology is used in the following description for convenience only and is not limiting. The words right, left, top and bottom designate directions in the drawings to which reference is made. The words inwardly and outwardly refer to directions toward and away from, respectively, the geometric center of the device and designated parts thereof. The words, anterior, posterior, superior, inferior and related words and/or phrases designate preferred positions and orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import.
(19) Referring to
(20) Generally speaking, the various embodiments of the intervertebral implant 10 are sized and configured to be implanted between adjacent vertebral bodies V. The intervertebral implants 10 may be sized and configured to replace all or substantially all of an intervertebral disc space D between adjacent vertebral bodies V or only part of the intervertebral disc space D. In addition, the preferred intervertebral implants 10 may be configured to replace an entire vertebral body V and related disc spaces D or multiple disc spaces D in a patient's spine, as is apparent to one having ordinary skill in the art.
(21) The intervertebral implants 10 of each of the preferred embodiments preferably include a plate 40 and a spacer 20. The spacer 20 may include a first insertion end portion 22 (e.g., front end), a second end portion 24 (e.g., rear end) opposite the first insertion end portion 22, a first lateral end 26, a second lateral end 28, an upper surface 30, and a lower surface 32. The spacer 20 is preferably configured and dimensioned for implantation into the intervertebral disc space D between adjacent vertebral bodies V. The spacer 20 is preferably sized and configured to maintain and/or restore a desired intervertebral disc height H between the adjacent vertebral bodies V.
(22) The plate 40 is preferably mounted to the second end portion 24 of the spacer 20 and preferably does not extend beyond the perimeter of the spacer 20. That is, a plate height h.sub.p of the plate 40 is preferably no more than a spacer height h.sub.s of the spacer 20 at the second end 24 so that the plate 40 does not increase the height profile of the spacer 20. In this manner, the intervertebral implant 10 has a low profile. Additionally, in this manner, the plate 40 may be entirely implanted into the intervertebral disc space D between the adjacent vertebral bodies V such that the plate 40 does not extend beyond an edge of the disc space D.
(23) The upper and lower surfaces 30, 32 of the spacer 20 may include a series of teeth, one or more keels, or other similar projections (not shown) to aid in securing the intervertebral implant 10 to the endplates of the adjacent vertebral bodies V. Alternatively or in addition, the spacer 20 may include one or more windows or channels (not shown) designed to receive bone graft material. For example, the spacer 20 may include one or more vertical windows or channels (not shown) extending through the spacer 20 from the upper surface 30 to the lower surface 32 for insertion of bone graft material such that bone growth is promoted through the vertical windows or channels following implantation of the intervertebral implant 10. Alternatively or in addition, the spacer 20 may have one or more horizontal windows or channels (not shown) extending through the spacer 20 from the first lateral end 26 to the second lateral end 28 for receiving bone graft material.
(24) The upper and lower surfaces 30, 32 of the spacer 20 may include a curved or a tapered surface to help provide the proper shape to the spine or to orient the endplates of the adjacent vertebral bodies V in a desired manner. The particular surface shape and curvature or taper in the anterior-posterior direction as well as between the first and second lateral ends 26, 28 will depend upon the location the implant 10 is intended to be implanted and/or surgeon preferences.
(25) The intervertebral implant 10 may be constructed of any suitable material or combination of materials including, but not limited to polymer (e.g. PEEK), titanium, titanium alloy, stainless steel, Nitinol, tantalum nitride (TaN), allograft bone, bioresorbable material, magnesium, composites, synthetic bone-welding polymers, etc. The plate 40 may be formed of a different material than the spacer 20. For example, the plate 40 may be formed of a metallic material such as, for example, a titanium or a titanium alloy, and the spacer 20 may be formed of a non-metallic material such as, for example, an allograft, a polymer, a bioresorbable material, a ceramic, etc. Alternatively, the plate 40 and the spacer 20 may be formed from the same material. For example, the plate 40 and the spacer 20 may both be constructed of tantalum nitride (TaN).
(26) The plate 40 preferably includes one or more through holes 42 for receiving fasteners 75 such as, for example, one or more bone screws 75, for securing the intervertebral implant 10 to the adjacent vertebral bodies V. The plate 40 may include any number of through holes 42 arranged in any number of combinations. For example, the plate 40 may include two, three, four or more through holes 42 for receiving, preferably, an equal number of bone screws 75. Moreover, the through holes 42 may alternate with one another with one through hole 42 being angled up and the next through hole 42 being angled down (
(27) The plate 40 of the preferred embodiments includes at least two through holes 42 configured to receive two fasteners 75 for securing the intervertebral implant 10 to the adjacent vertebral bodies V. The at least two through holes 42 preferably diverge so that at least one fastener 75 is secured into the upper vertebral body V while at least one other fastener 75 is secured into the lower vertebral body V so that opposing forces act on the plate 40 and/or vertebral bodies V. Alternatively, the plate 40 may include three through holes 42 configured to receive three fasteners 75. One fastener 75 may penetrate the upper vertebral body V and two fasteners 75 may penetrate the lower vertebral body V, or vice versa. Alternatively, the plate 40 may include four or more through holes 42 configured to receive four or more fasteners 75. In such a configuration, two inner fasteners 75 may penetrate the upper vertebral body V while two outer fasteners 75 may penetrate the lower vertebral body V, or vice versa, or some combination thereof.
(28) The through holes 42 each include a hole axis 43 such that one of the holes 42 exit through the upper surface of the intervertebral implant 10, possibly through the upper surface 30, for engaging the upper vertebral body V while another of the holes 42 exit through the lower surface of the intervertebral implant 10, possibly through the lower surface 32 for engaging the lower vertebral body V. The fastener 75 that extends through the hole 42, preferably along the hole axis 43 forms a fastener angle with respect to the upper and lower surfaces 30, 32 of the spacer 20 wherein fastener angle may be in the range between twenty degrees (20) and fifty degrees (50), and most preferably between thirty degrees (30) and forty-five degrees (45). The fastener angle may be the same for all of the holes 42 or may be different for each of the holes 42.
(29) The through holes 42 formed in the plate 40 preferably are directed outwardly from the center of the intervertebral implant 10, preferably at a lateral fastener angle . Thus, the through holes 42 preferably extend laterally outward from a center plane 11 of the intervertebral implant 10 at the lateral fastener angle . The lateral fastener angle may be the same for all holes 42 or may be different for each hole 42.
(30) Exit openings 42a of the through holes 42 may be formed in the plate 40 or in the spacer 20. The through holes 42 may also include one or more threads (not shown) for threadably engaging threads formed on a head portion 75a of the bone screw 75 in order to secure the bone screws 75 to the plate 40 and to generally lock the position of the bone screws 75 relative to the plate 40 and/or spacer 20.
(31) The intervertebral implant 10 of the preferred embodiments also preferably includes a coupling mechanism 100 for securing the plate 40 to the spacer 20. Generally speaking, the spacer 20 and the plate 40 are coupled together by the coupling mechanism 100 prior to being implanted into the disc space D. However, in certain embodiments, the intervertebral implant 10 may be configured so that the plate 40 may be coupled to the spacer 20 after one of the spacer 20 and plate 40 have been implanted into the intervertebral disc space. Once coupled, the spacer 20 and plate 40 preferably form a solid implant. The coupling mechanism 100 may be any of the coupling mechanisms 100 described herein or their structural equivalents.
(32) Referring to a first preferred embodiment of the intervertebral implant 10 shown in
(33) The circumferential arm 102 may be made from a material that deforms or shrinks as a result of being heated or cooled such as, for example, Nitinol or any other suitable material that deforms as a result of temperature variation. In this manner, the plate 40 may be fixed to the spacer 20 by heating or cooling the plate 40, thereby causing the arm 102 of the plate 40 to shrink, which in turn causes the arm 102 to circumferentially engage the spacer 20. This first preferred embodiment of the intervertebral implant 10 is particularly useful since it enables relatively loose tolerances during manufacturing of the spacer 20.
(34) Referring to a second preferred embodiment of the intervertebral implant 10 shown in
(35) As best shown in
(36) Referring to
(37) Referring to the fourth preferred embodiment of the intervertebral implant 10 shown in
(38) In addition, the coupling mechanism 100 of the fourth preferred embodiment may include one or more rotatable cams 125, preferably coupled to the plate 40 to lock the spacer 20 to the plate 40 after the spacer 20 is slid onto the plate 40. Alternatively, the one or more rotatable cams 125 may act as a depth stop to prevent the plate 40 and the spacer 20 from sliding completely past one another as the spacer 20 slides onto the plate 40 to engage the projections 122 with the recesses 120, respectively. The cam 125 may be included on either or both of the upper and lower surfaces of either or both of the plate 40 and spacer 20. Preferably, for example, the plate 40 may include one or more cams 125 on the upper and lower surfaces of the plate 40, wherein the cam 125 is sized and configured to engage one or more recesses 126 formed on the upper and lower surfaces 30, 32 of the spacer 20. In use, the plate 40 and the spacer 20 may be coupled to each other by rotation of the cam 125, which may be accomplished by hand or with the benefit of a tool.
(39) Referring to the fifth preferred embodiment of the intervertebral implant 10 shown in
(40) Referring to the seventh preferred embodiment of the intervertebral implant 10 shown in
(41) Referring to the eighth preferred embodiment of the intervertebral implant 10 shown in
(42) Referring to the ninth preferred embodiment of the intervertebral implant 10 shown in
(43) Alternatively and/or in addition, as best shown in
(44) Referring to the eleventh preferred embodiment of the intervertebral implant 10 shown in
(45) The various coupling mechanisms 100 disclosed herein may also include an adhesive bonding for additional coupling of the plate 40 to the spacer 20. That is, various methods of bonding the spacer 20 to the plate 40 may be used in connection with the various coupling mechanisms 100 disclosed herein. These methods, may include, but are not limited to, chemical bonding or process, ultrasound, ultraviolet light, adhesives, bone welding, clamping etc. These methods may be used in addition, or instead of other coupling mechanisms 100.
(46) Furthermore, referring to a twelfth preferred embodiment of the intervertebral implant 10 shown in
(47) Alternatively, the intervertebral implant 10 of the twelfth preferred embodiment may incorporate a plate 40 coupled to the spacer 20 and welded to the synthetic bone material fasteners 75 by, for example, ultrasound, thereby eliminating the need for any mechanical locking mechanism when the fasteners are mounted in the through holes 42 in an implanted position. In use, manufacturing the spacer 20 from an allograft or resorbable material and incorporating synthetic bone material fasteners 75 results in only the plate remaining within the patient, if any component of the implant 10 remains within the patient, due to the materials resorbing into the patient's body. It should be noted, however, that it is envisioned that synthetic bone material fasteners 75, which may be welded in-situ to the adjacent vertebral bodies V, may be used in connection with any of the intervertebral implants 10 now or hereafter known including any of the various embodiments of the implant 10 described herein.
(48) The intervertebral implants 10 of each of the twelve preferred embodiments are generally sized and configured for anterior insertion, although different configurations may be possible for lateral, antero-lateral or posterior approaches. In addition to the features described, the intervertebral implant 10 may include threaded holes, slots or channels to mate with instruments to facilitate manipulation and insertion.
(49) Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention.
(50) It will be appreciated by those skilled in the art that various modifications and alterations of the invention can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be apparent to those skilled in the art. For example, the present invention may be employed in different sections of the spinal column, including, but not limited to, the cervical area.