MONOAXIAL - UNIPLANAR HYBRID SCREW
20220087721 · 2022-03-24
Inventors
Cpc classification
A61B17/7032
HUMAN NECESSITIES
A61B17/7038
HUMAN NECESSITIES
International classification
Abstract
A spinal rod anchoring device is disclosed comprising a body comprising a distal end and a proximal end, wherein a threaded bone anchor is positioned toward the distal end, and a U-shaped head portion is positioned toward the proximal end. The head portion and the threaded bone anchor are fixedly attached. The spinal rod anchoring device also comprises a saddle comprising a concave interior region wherein the interior region has an open channel. The saddle is moveably seated within the base of the head portion, and a spinal connection element is disposed on the saddle. The spinal rod anchoring device further comprises a retaining pin configured to be inserted through the channel in the saddle and secured in a groove, wherein the groove is centrally positioned within the head portion, wherein the retaining pin secures the saddle to the head portion.
Claims
1. A spinal rod anchoring device comprising: a body comprising a distal end and a proximal end, wherein a threaded bone anchor is positioned toward the distal end, and a U-shaped head portion is positioned toward the proximal end, wherein the head portion is formed by a concave base with an extension on each end of the concave base, wherein the head portion and the threaded bone anchor are attached to one another; a saddle comprising a concave interior region, wherein the interior region has an open channel therewithin, wherein the saddle is moveably seated within the base of the head portion, and wherein a spinal connection element is disposed on the saddle; and a retaining pin configured to be inserted through the channel in the saddle and secured in a groove, wherein the groove is centrally positioned within the head portion, wherein the retaining pin secures the saddle to the head portion; wherein the saddle rotates about a single axis and angulates the spinal connection element about the single axis thereof.
2. The spinal rod anchoring device of claim 1 further comprising a closure mechanism configured to be positioned within the head portion.
3. The spinal anchoring device of claim 2, wherein the closure mechanism locks the spinal connection element and the saddle in an angulation relative to the body about the single axis
4. The spinal anchoring device of claim 1, wherein the retaining pin comprises a proximal end and a distal end, wherein the retaining pin comprises a conical taper at the proximal end and two or more wire slits at the distal end.
5. The spinal anchoring device of claim 4, wherein the retaining pin further comprises an extension disposed about at least a portion of the distal end.
6. The spinal anchoring device of claim 1, wherein the retaining pin is configured to flex into the groove positioned within the head portion.
7. The spinal anchoring device of claim 1, wherein the groove extends toward the distal end of the body.
8. The spinal anchoring device of claim 1, wherein the head portion is configured to movably seat the saddle, and wherein the saddle and the head portion comprise two matching radii.
9. The spinal anchoring device of claim 1, wherein the saddle further comprises an upper surface profile and a lower surface profile, wherein the profile of the upper surface compliments the profile of the spinal connection element.
10. The spinal anchoring device of claim 9, wherein the lower surface profile of the saddle compliments the base of the head portion upon which the saddle is seated.
11. The spinal anchoring device of claim 1, wherein the saddle comprises a convex lower surface.
12. A spinal rod anchoring device comprising: a body comprising a distal end and a proximal end, wherein a threaded bone anchor is positioned toward the distal end, and a U-shaped head portion is positioned toward the proximal end, wherein the head portion and the threaded bone anchor are fixedly attached; a saddle comprising a concave interior region, wherein the interior region has an open channel therewithin, wherein the saddle is moveably seated within the base of the head portion, and wherein a spinal connection element is disposed on the saddle; and a retaining pin configured to be inserted through the channel in the saddle and secured in a groove, wherein the groove is centrally positioned within the base of the head portion, wherein the retaining pin secures the saddle to the head portion; a closure mechanism configured to be positioned within the head portion; wherein the saddle and the head portion comprise two matching radii, wherein the saddle rotates about a single axis and angulates the spinal connection element about the single axis thereof, and wherein the closure mechanism locks the spinal connection element and the saddle in an angulation relative to the body about the single axis.
13. The spinal anchoring device of claim 12, wherein the retaining pin comprises a proximal end and a distal end, wherein the retaining pin comprises a conical taper at the proximal end and two or more wire slits at the distal end.
14. The spinal anchoring device of claim 13, wherein the retaining pin further comprises an extension disposed about at least a portion of the distal end.
15. The spinal anchoring device of claim 12, wherein the retaining pin is configured to flex into the groove positioned within the head portion.
16. The spinal anchoring device of claim 12, wherein the groove extends toward the distal end of the body.
17. The spinal anchoring device of claim 12, wherein the saddle further comprises an upper surface profile and a lower surface profile, wherein the profile of the upper surface compliments the profile of the spinal connection element.
18. The spinal anchoring device of claim 12, wherein the saddle comprises a convex lower surface.
19. A method comprising: fastening two or more spinal rod anchoring devices into two or more vertebra, wherein each spinal rod anchoring device comprises: a body comprising a distal end and a proximal end, wherein a threaded bone anchor is positioned toward the distal end, and a U-shaped head portion is positioned toward the proximal end, wherein the head portion and the threaded bone anchor are fixedly attached; a saddle comprising a concave interior region, wherein the interior region has an open channel therewithin, wherein the saddle is moveably seated within the base of the head portion, and wherein a spinal connection element is disposed on the saddle; a retaining pin configured to be inserted through the channel in the saddle and secured in a groove, wherein the groove is centrally positioned within the base of the head portion, wherein the retaining pin secures the saddle to the head portion; a closure mechanism configured to be positioned within the head portion; positioning the spinal connection element about a single axis relative to the body of a first spinal rod anchoring device, wherein the positioning comprises translating and angulating the saddle within the head portion; positioning the spinal connection element attached to the first spinal rod anchoring device and; interconnecting at least a second rod anchoring device with the spinal connection element.
20. The method of claim 19, wherein the saddle and the head portion comprise two matching radii, wherein the saddle rotates about a single axis and angulates the spinal connection element about the single axis thereof, and wherein the closure mechanism locks the spinal connection element and the saddle in an angulation relative to the body about the single axis.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this application, illustrate certain non-limiting embodiments of inventive concepts. In the drawings:
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DETAILED DESCRIPTION
[0019] It is to be understood that the present disclosure is not limited to particular devices or methods, which may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. All numbers and ranges disclosed herein may vary by some amount. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number and any included range falling within the range are specifically disclosed. Although individual embodiments are discussed herein, the invention covers all combinations of all those embodiments. As used herein, the singular forms “a”, “an”, and “the” include singular and plural referents unless the content clearly dictates otherwise. Furthermore, the word “may” is used throughout this application in a permissive sense (i.e., having the potential to, being able to), not in a mandatory sense (i.e., must). The term “include,” and derivations thereof, mean “including, but not limited to.” The term “coupled” means directly or indirectly connected. If there is any conflict in the usages of a word or term in this specification and one or more patent or other documents that may be incorporated herein by reference, the definitions that are consistent with this specification should be adopted for the purposes of understanding this invention.
[0020] This disclosure relates to an apparatus for securing a spinal rod along the spine and, further, to an apparatus for locking a spinal rod in a coupling member of a spinal rod anchoring device. More particularly, the disclosed monoaxial-uniplanar hybrid screw provides a low-profile implant, rigid in three planes with “pseudo-angulation” in a single direction via saddle angulation and translation. An adjustable bone screw assembly is provided that allows for controlled adjustment of a spinal connection element, such as a spinal rod, received in a body of the bone screw assembly relative to the body of the bone screw. The adjustable bone screw assembly may allow the spinal connection element received in a receiving portion of the assembly to pivot about a single axis, while limiting movement in other directions. This disclosure relates to an apparatus having the rigidity and low profile of a monoaxial screw and the single direction angulation of a uniplanar screw, allowing the user to employ deformity techniques, such as axial derotation.
[0021] The monoaxial-uniplanar hybrid screw may allow a surgeon to rotate vertebral bodies and facilitates rod placement into the rod-receiving portion. The monoaxial-uniplanar hybrid screw may allow the surgeon to achieve an ideal orientation of the spinal rod relative to the bone screw without requiring the spinal rod to have a predetermined, fixed orientation, or necessarily be perpendicular to the longitudinal axis of the screw shank.
[0022] The exemplary monoaxial-uniplanar hybrid screw assembly of the illustrative embodiments may be employed to engage one or more spinal connection elements to bone. For example, a monoaxial-uniplanar hybrid screw may be employed to fix a spinal plate, rod, and/or cable to a vertebra of the spine. Although the disclosed exemplary monoaxial-uniplanar hybrid screw assemblies are designed primarily for use in spinal applications, and specifically the pedicle region of a vertebra, one skilled in the art will appreciate that the structure, features and principles of the exemplary monoaxial-uniplanar hybrid screw assemblies, as well as the other disclosed exemplary embodiments, may be employed to couple any type of orthopedic implant to any type of bone or tissue. The monoaxial-uniplanar hybrid screw described herein facilitates the correction of the position, for example, the angular orientation, of the vertebra in which the monoaxial-uniplanar hybrid screw assembly is implanted.
[0023] The illustrative monoaxial-uniplanar hybrid screw assembly may be used to attach a non-rigid member to bone. For example, the monoaxial-uniplanar hybrid screw may be used to attach a rod, ligament, bar, cable, or other non-rigid member extending between and connecting two bone screws, for example for connecting superior and inferior vertebra. Alternatively, the monoaxial-uniplanar hybrid screw may be used to attach a rigid member to bone. While the disclosure relates to a monoaxial-uniplanar hybrid screw that receives a spinal rod that is movable about a single axis relative to the monoaxial-uniplanar hybrid screw, the disclosure is not limited to spinal rods and may be used with any suitable spinal connection element to be coupled to bone.
[0024] The monoaxial-uniplanar hybrid screw and any of its components may be constructed of a non-organic material that is durable and that can be implanted in a human body, such as titanium, stainless steel, spring steel, aluminum, Niobium, carbon fiber, ceramics, polymers, composites or any relatively hard material (e.g. titanium-aluminum-niobium-alloy). Generally, the material selected will be biocompatible, that is, compatible with the surrounding bone and tissue.
[0025] In accordance with the present disclosure, a method of spinal fixation using the monoaxial-uniplanar hybrid screw assembly, according to some embodiments, may comprise fastening two or more monoaxial-uniplanar hybrid screw assemblies into two or more vertebra, the monoaxial-uniplanar hybrid screw assembly comprising a body, wherein the body comprises a distal end and a proximal end, wherein a threaded bone anchor portion is positioned toward the distal end, and a U-shaped head portion is positioned toward the proximal end; a saddle; a retaining pin; and a closure mechanism, such as a set screw, plug, cap, or similar type of closure mechanism. The method further comprises positioning the spinal rod about the axis relative to the body of a first monoaxial-uniplanar hybrid screw assembly, wherein the positioning of the spinal rod occurs by translating and angulating the saddle within the concave recess of the head portion; and wherein the retaining pin prevents over-translating and disassembling of the saddle within the head portion. The method further comprises correcting the position of the spine by manipulating and positioning the spinal rod attached to the first monoaxial-uniplanar hybrid screw assembly and interconnecting at least a second monoaxial-uniplanar hybrid screw assembly with the spinal rod.
[0026] Referring now to
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[0028] The monoaxial-uniplanar hybrid screw assembly 200 further comprises a closure mechanism 203, such as a set screw, plug, cap, or similar type of closure mechanism. The closure mechanism 203 may be used to lock the spinal rod 201 or other spinal connection element into the rod-receiving portion 115 of the head 113.
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[0031] The head portion 113 may be configured to movably seat the saddle 103, upon which the rod 201 is disposed. The retaining pin 105 may be inserted through the saddle 103 and secured in a groove (not shown) centrally positioned at the base 205 of the head portion 113. The head portion 113 may be configured to receive a spinal rod 201 or other suitable spinal connection element. The head portion 113 may form a U-shaped opening 115, wherein the U-shaped opening 115 is formed by a concave base 207 with an extension 209 on each end of the concave base 207, whereby the extensions 209 form closed sides 211. It should be noted that some embodiments may be comprised of other suitable openings, other than U-shaped, at the proximal end 109 of the body 101 for receiving a spinal rod 201. The head portion 113 may be configured to accommodate any suitable spinal connection element 201. The head portion 113 of the monoaxial-uniplanar hybrid screw assembly 200 may be closed with a set screw 203, as illustrated, or other closure mechanism. The closure mechanism 203 secures the spinal rod 201 or other suitably configured spinal connection element within the slot 115 of the head portion 113, thereby locking the spinal rod 201 and the saddle 103 in the selected angulation within and relative to the body 101 of the monoaxial-uniplanar hybrid screw assembly 200. The head portion 113 may be fixedly or rigidly coupled to or integral with the threaded bone anchor portion 111 to form the body 101.
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[0036] The spinal rod 201 may be disposed upon the upper surface 137 the saddle 103, as the saddle 103 allows for pivoting of the spinal rod 201 about the X-X axis relative to the body 101 of the monoaxial-uniplanar hybrid screw assembly 200. The concave recess 207 at the base 205 of the head portion 113 of the body 101 of the monoaxial-uniplanar hybrid screw assembly 200 is configured to receive the convex curvature of the lower surface 139 of the saddle 103. The convex curvature of the lower surface 139 of the saddle 103 allows pivoting of the saddle 103 within the recess 207 along a single axis, wherein the retaining pin 105, inserted within and through the cut-out or channel 143, secures the saddle 103 in place, thereby allowing for single axis rotation.
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[0040] The recesses or channels 213 disposed about the internal surfaces 215 of the extension sides 209 may also help guide movement of the spinal rod 201 and the saddle 103 upon which the spinal rod 201 is disposed upon. In other embodiments, the internal surfaces 215 of the extension sides 209 may comprise threads (not shown) disposed thereupon, wherein the threads allow for threadably coupling a closure mechanism, such as a set screw (not shown).
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[0043] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the present disclosure, even where only a single embodiment is described with respect to a particular feature. Examples of features provided in the disclosure are intended to be illustrative rather than restrictive unless stated otherwise. The above description is intended to cover such alternatives, modifications, and equivalents as would be apparent to a person skilled in the art having the benefit of this disclosure.
[0044] The scope of the present disclosure includes any feature or combination of features disclosed herein (either explicitly or implicitly), or any generalization thereof, whether or not it mitigates any or all of the problems addressed herein. Various advantages of the present disclosure have been described herein, but embodiments may provide some, all, or none of such advantages, or may provide other advantages.