Pedicle screw system and method of installing the same

Abstract

A pedicle screw comprising a screw shank, a tulip head, a collet, and a set screw. The screw shank having a thread disposed along a length thereof and a connector positioned at a proximal end. The tulip head having a proximal opening, a distal opening, and a pair of opposing arms, wherein each arm of the pair of opposing arms has an interior wall with internal threads disposed thereon. The collet having an upper collet portion, a lower collet portion, a proximal opening, a distal opening, wherein the upper collet portion includes a pair of opposing arms, and wherein the lower collet portion includes a plurality of fingers. The set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw.

Description

QRT0060W0.0815823PEDICLE SCREW SYSTEM AND METHOD OF INSTALLING THE SAMECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority benefit of U.S. Provisional Patent Application No. 63 / 728,223, filed December 5, 2024, which is hereby incorporated herein by reference in its entirety.BACKGROUND

[0002] Pedicle screw systems are widely used in spinal surgeries to stabilize and support the spine. These systems typically involve the insertion of screws into the pedicles of vertebrae, which are then connected by rods to provide structural support and maintain spinal alignment. The primary goal of these systems can be to treat various spinal conditions, such as scoliosis, fractures, degenerative disc disease, and spinal deformities, by ensuring that the vertebrae remain in proper alignment. Over the years, numerous advancements have been made in the design and functionality of pedicle screw systems to enhance their effectiveness and minimize complications.

[0003] Despite the advancements, several challenges remain in the current pedicle screw systems. The present invention relates to such advancements in pedicle screw systems, offering novel solutions to enhance spinal stabilization and patient recovery.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] While the specification concludes with claims which particularly point out and distinctly claim this technology, it is believed this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0005] FIG. 1 depicts a cross-sectional view of an embodiment of a pedicle screw of the present disclosure;QRT0060W0.0815823

[0006] FIG. 2 depicts a cross-sectional view of the pedicle screw of FIG. 1 with a connector rod positioned therein;

[0007] FIG. 3 depicts an exploded cross-sectional view of the pedicle screw and connector rod of FIG. 2;

[0008] FIG. 4 depicts an exploded view of the pedicle screw and connector rod of FIG. 2;

[0009] FIG. 5 depicts a cross-sectional view of a screw shank embodiment of FIG. 4;

[0010] FIG. 6 depicts a cross-sectional view of a tulip head embodiment of FIG. 4;

[0011] FIG. 7 depicts a bottom view of the tulip head of FIG. 6;

[0012] FIG. 8 depicts a top view of the tulip head of FIG. 6;

[0013] FIG. 9 depicts a side perspective view of the tulip head of FIG. 6;

[0014] FIG. 10 depicts an exploded view of an embodiment of a pedicle screw of the present disclosure;

[0015] FIG. 11 depicts a cross-sectional view of an embodiment of the collet of FIG. 4;

[0016] FIG. 12 depicts a top view of the collet of FIG. 11 ;

[0017] FIG. 13 depicts a bottom view of the collet of FIG. 11 ;

[0018] FIG. 14 depicts a cross-sectional view of an embodiment of the set screw of FIG.4;

[0019] FIG. 15 depicts a top view of the set screw of FIG. 14;

[0020] FIG. 16 depicts a bottom view of the set screw of FIG. 14;

[0021] FIG. 17A depicts a thread profile of the set screw of FIG. 14;

[0022] FIG. 17B depicts a thread profile of the tulip head of FIG. 6;QRT0060W0.0815823

[0023] FIG. 17C depicts another thread profile of a tulip head of the present disclosure;

[0024] FIG. 17D depicts yet another thread profile of a tulip head of the present disclosure;

[0025] FIG. 18 depicts a cross-sectional view of an embodiment of the locking lug ofFIG. 4;

[0026] FIG. 19 depicts an exploded view of an embodiment of a driving tool of the present disclosure prior to engagement with a pedicle screw of the present disclosure;

[0027] FIG. 20 depicts a side perspective view of the driving tool of FIG. 19 engaged with the pedicle screw;

[0028] FIG. 21 depicts a front side view of the driving tool of FIG. 19;

[0029] FIG. 22 depicts a front side view of a driving end of a driver of the driving tool ofFIG. 19 prior to engagement with the pedicle screw;

[0030] FIG. 23 depicts a front side view of the driving end of the driver of the driving tool of FIG. 19 engaged with the pedicle screw;

[0031] FIG. 24 depicts a front side view of a driving end of a driver of an embodiment of a driving tool of the present disclosure engaged with a pedicle screw of the present disclosure;

[0032] FIG. 25 depicts a front side view of a driving end of a driver of an embodiment of a driving tool of the present disclosure engage with a pedicle screw of the present disclosure;

[0033] FIG. 26 depicts a side perspective view of an embodiment of a driving tool of the present disclosure engaged with a pedicle screw of the present disclosure;

[0034] FIG. 27 depicts a side perspective view of an embodiment of a driving tool of the present disclosure engaged with a pedicle screw of the present disclosure; andQRT0060W0.0815823

[0035] FIG. 28 depicts an exploded view of how the set screw of FIG. 14 may be utilized with a connector rod and a hook implant device.

[0036] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present technology, and together with the description serve to explain the principles of the technology; it being understood, however, that this technology is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0037] The following text sets forth a broad description of numerous different embodiments. The description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical, if not impossible, and it will be understood that any feature, characteristic, component, composition, ingredient, product, step or methodology described herein can be deleted, combined with or substituted for, in whole or part, any other feature, characteristic, component, composition, ingredient, product, step or methodology described herein. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.

[0038] It should also be understood that, unless a term is expressly defined in this specification using the sentence “As used herein, the term ‘ ’ is hereby defined to mean . . .” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). No term is intended to be essential unless so stated. To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such a claim term be limited,QRT0060W0.0815823 by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.

[0039] It has been discovered that one significant issue for spinal implants and systems can be the risk of a spinal screw loosening or misplacement, which can lead to inadequate spinal stabilization and potential injury to the patient. Additionally, variations in patient anatomy and bone quality can complicate the accurate placement of screws and rods of spinal systems, potentially resulting in suboptimal outcomes. One or more embodiments described herein aim to provide better biomechanical stability, ease of use, and adaptability to varying patient anatomies. By improving the precision and reliability of screw placement, one or more of these embodiments also seek to reduce the risk of complications and improve overall surgical outcomes.

[0040] One or more embodiments described herein generally relate to a pedicle screw for spinal surgical procedure such as the amelioration and / or correction of scoliosis or other conditions of the spine wherein the threaded screw shank can be loaded into the head from the bottom. A pedicle screw can typically be inserted thru the pedicles and into the vertebral body.

[0041] Referring to FIGS. 1 through 4, a universal pedicle screw 100 is shown. As used herein, the term “universal” is hereby defined to mean that pedicle screw 100 is capable of operating as both a uniplanar pedicle screw and a polyaxial pedicle screw. In the illustrative embodiment shown, pedicle screw 100 includes a screw shank 2, a tulip head 4, a collet 6, a locking lug 8, and a set screw 10. When assembled together, these components form pedicle screw 100. In one or more embodiments, pedicle screw 100 does not include a retaining ring, wire, e-clip, c-clip, or similar retaining structure. The geometry of tulip head 4 and collet 6 allows for positive axial retention of the assembly without other means of axial constraint such as retaining rings, wire, e-clip, c-clip, or similar retaining structure. FIGS. 2 through 4 also show how a connector rod 12 can be utilized within pedicle screw 100. Each of the components set forth above may be individually described below herein and shown inORT0060W0.0815823 separate figures. In addition, it may be shown and described below herein how each of the components of pedicle screw 100 are interconnected and, once assembled, how the pedicle screw works in operation.

[0042] Referring to FIG. 5, one embodiment of screw shank 2 of pedicle screw 100 is shown. Screw shank 2 can include at least one helical thread 14 formed along a length thereof. It may be important to note that the proportions of screw shank 2 are for illustrative purposes only, and variations in the length of the shank, diameter of the screw, thread pitch, thread length, and number of thread leads may be varied without departing from the scope of the disclosure. Variable thread pitches and diameters have also been contemplated. As described later in this specification, screw shanks 2 of various widths, lengths, and various thread sizes are compatible with the same tulip head 4 reducing the manufacturing inventory. At the proximal end of screw shank 2 may be a spherical connector / head 16 having a predetermined diameter. In one or more embodiments, head 16 may have a hemispherical or oblong form and yield the same results as discussed below for head 16 having a spherical shape. In an embodiment, spherical connector 16 includes a spherical surface 18 spanning a full 360 degrees or substantially around spherical connector 16. Head 16 may be substantially spherical, hemispherical, or oblong.

[0043] Along two sides of spherical connector 16 are two uni-pin holes 20a, 20b, discussed in more detail below. In one or more embodiments, uni-pin holes 20a and 20b are located on opposed sides circumferentially offset 180 degrees of one another through a center of a spherical diameter of spherical connector 16. A shank collar 22 connects spherical connector 16 and helical threaded portion 14. Shank collar 22 may be a section of the screw shank 2 of reduced diameter which transitions between spherical connector 16 and threaded portion 14 of screw shank 2. Shank collar 22 provides clearance between tulip head 4 and helical thread 14 while allowing for angulation adjustments during surgery to allow pedicle screw 100 to accept connector rod 12.

[0044] In an embodiment, a diameter of shank collar 22 may approximately be the same as a minor diameter of helical thread 14. Shank collar 22 may also be smaller or larger depending on angulation and strength requirements of pedicle screw 100. Further, a driverQRT0060W0.0815823 receptacle 24 can be located along a proximal end of spherical connector 16 for use in installing pedicle screw 100 by use of a driving tool, discussed in further detail below. As shown in FIG. 5, uni-pin holes 20a, 20b do not traverse into the area occupied by driver receptacle 24. In yet another embodiment, uni-pin holes 20a and 20b may traverse into the area occupied by driver receptacle 24. It should be noted that the driver receptacle 24 may be any shape, male or female, suitable for cooperation with a driving tool to rotate and / or drive pedicle screw 100 into its final position.

[0045] Spherical connector 16 of screw shank 2 has multiple geometries. In an embodiment, spherical connector 16 may be smooth without ridges or other surface perturbances as shown in FIGS. 1 through 5 for example. Specifically, a spherical portion of spherical connector 16 maintains a spherical geometry within the bounds of normal machining or manufacturing variances. In another embodiment, spherical connector 16 may include surface perturbances (not shown). In various embodiments, surface perturbances may be ridges, grooves, coatings, or surface roughness achieved by secondary operations, such as, but not limited to blasting of spherical connector 16 to add a higher coefficient of friction. Surface perturbances may be formed in a vertical, horizontal, radial, crosshatched, circular, or isotropic arrangement on a surface of spherical connector 16. Surface protuberances may provide increased friction and / or adhesion between screw shank 2 and collet 6.

[0046] Referring to FIGS. 6 through 8, one embodiment of tulip head 4 of pedicle screw 100 is shown. Tulip head 4 defines a proximal opening 30 and a distal opening 32. Proximal opening 30 and distal opening 32 may be connected to form a single cavity extending through tulip head 4 from a proximal end 34 to a distal end 36 of tulip head 4. Proximal opening 30 has a diameter (Duo) while distal opening 32 has a diameter (DLQ). In one or more embodiments, D o ’slarger than DLO- Proximate to distal end 36, an interior wall of tulip head 4 can include a collet compression inducing face / squanch face 38 disposed therein. In one or more embodiments, collet compression inducing face 38 assists in compressing collet fingers (discussed in detail below) of collet 6 against spherical connector 16 of screw shank 2. Proximate to compression inducing face 38 may be a relief bore 39. In one or more embodiments, relief bore 39 allows for the fingers (discussed in detail below) of collet 6 to expand during assembly.QRT0060W0.0815823

[0047] Tulip head 4 further includes a pair of arms 38a and 38b which define a channel 40 transverse to the single cavity extending between proximal opening 30 and distal opening 32 and a longitudinal axis of tulip head 4. Although shown in FIG. 6 as being significantly U-shaped, channel 40 may be any geometry that allows for channel 40 to receive and hold a portion of connector rod 12. In an embodiment, internal threads 42 are formed in arms 38a and 38b. The thread profile of internal threads 42 may be any profile known to one skilled in the art. Non-limiting examples of internal threads 42 include reverse angle threads, v-threads, square threads, ACME threads, and buttress threads. Internal threads 42 may be configured to receive and threadingly engage an externally threaded set screw, such as set screw 10. As shown in FIG. 6, the internal threads 42 include a plurality of roots 41 and crests 43. The each of the roots 41 may have a Load Flank (ILF) and a Relief Flank (IRF).

[0048] In an embodiment, external tulip head pockets 44 are formed in arms 38a and 38b. In the embodiments shown, external tulip head pockets 44 do not extend transversely all the way across the tulip head 4. Thus, as shown in FIG. 9, the external tulip head pockets 44 each have a proximal wall 46 that includes a tulip head undercut 47, two opposed side walls 48, a back wall 50, and a lower wall 52. In one or more embodiments, tulip head pockets 44, and more specifically, tulip head undercut 47, are constructed to engage various orthopedic surgical tools (e.g., a rod reducer) configured to facilitate installation, removal, and / or adjustment of pedicle screws 100, set screw 10, or a spinal rod. Also shown in FIG. 9 are engagement regions 49 located on each external side of each arm 38a and 38b. In one or more embodiments, engagement regions 49 take the form of bump-outs 49. Bump-outs 49 are utilized in conjunction with a driving tool (discussed in detail below), utilized to drive pedicle screw 100 into position in a patient. In one or more embodiments, bump-outs 49 may interface with other surgical instruments besides the driving tool discussed in detail below.

[0049] In one or more embodiments, tulip head 4 also includes a locking lug through hole 54. As discussed in further detail below, locking lug 8 may be placed within locking lug through hole 54 to lock collet 6 into position within tulip head 4. In one or more embodiments, tulip head 4 may also include uni-pin holes 56a and 56b, which are located on opposed sides circumferentially offset 180 degrees of one another on tulip head 4. As shown in FIG. 10, if pedicle screw 100 operates as a uniplanar pedicle screw, uni-pins 58a and 58bQRT0060W0.0815823 may be placed into tulip head uni-pin holes 56a and 56b, through clearance channels (discussed in detail below) in collet 6, and then into uni-pin holes 20a and 20b on spherical connector 16 of screw shank 2. Once positioned, uni-pin peen holes 60a and 60b may be peened so as to displace the material of tulip head 4 positioned adjacent holes 60a and 60b, which may axially retain uni-pins 58a and 58b into position. In one or more embodiments, uni-pin peen holes 60a and 60b are located on opposed sides circumferentially offset 180 degrees of one another on tulip head 4 in a position above tulip head uni-pin holes 56a and 56b. In one or more embodiments, tulip head 4 may not include uni-pin peen holes 60a and 60b, and uni -pins 58a and 58b may be secured through alternative methods such as a press fit, welding, brazing, threading, or other similar manners of securement.

[0050] Referring to FIGS. 11 through 13, one embodiment of collet 6 of pedicle screw 100 is shown. Collet 6 defines a proximal opening 62 and a distal opening 64. Proximal opening 62 and distal opening 64 may form a single cavity extending through collet 6 from a proximal end 66 to a distal end 68. As shown in FIGS. 11 and 12, collet 6 has a collet upper diameter (DQ[J) at proximal end 66 and an unexpanded collet lower diameter (PuCL)atdistal end 68. In one or more embodiments, D^u is smaller than DucL- Collet 6 also includes a collet upper portion 70 and a lower collet portion 72. Lower collet portion 72 includes one or more slots 74 extending radially therethrough so as to define a plurality of fingers 76. Collet upper portion 70 further includes a pair of arms 78a and 78b which define a channel 80 transverse to the single cavity extending between proximal opening 62 and distal opening 64. Although shown in FIG. 11 as being significantly U-shaped, channel 80 may be any geometry that allows for channel 80 to receive and hold a portion of connector rod 12. Each arm 78a, 78b includes a flat proximal end 82. As shown in Fig. 11, proximal end 82 of arm 78b includes a locking lug cavity 84 extending down into arm 78b from proximal end 82. Although shown extending down from proximal end 82 of arm 78b, locking lug cavity 84 may also extend down from proximal end 82 of arm 78a as opposed to arm 78b, and it may also be that both arms 78a and 78b could both include a locking lug cavity 84. Although shown throughout the Figures as being open at a proximal end thereof, in yet other embodiments, locking lug cavity 84 can be closed at a proximal end thereof.

[0051] Also included in lower collet portion 72 of collet 6 are uni-pin channels 86a andQRT0060W0.081582386b. As discussed above, if pedicle screw 100 operates as a uniplanar pedicle screw, uni-pins 58a and 58b may be placed into tulip head uni-pin holes 56a and 56b, through uni-pin channels 86a and 86b in collet 6, and then into uni-pin holes 20a and 20b on spherical connector 16 of screw shank 2. Uni-pin channels 86a and 86b are located on opposed sides circumferentially offset 180 degrees of one another on lower collet portion 72. Although shown throughout the Figures as being open at a distal end thereof, in yet other embodiments, uni-pin channels 86a and 86b may be closed at a distal end thereof.

[0052] In use (discussed in further detail below), collet 6 may be pressed over spherical connector 16 of screw shank 2 such that fingers 76 can elastically deform to allow the spherical connector 16 of screw shank 2 to insert within fingers 76 and then deform back enough to grasp the spherical connector 16. The relationship between collet compression inducing face 38 of tulip head 4 and fingers 76 may be an elastically deformed state that may hinder spherical connector 16 of screw shank 2 from being removed from distal opening 32 of tulip head in an axially downward direction.

[0053] Referring to FIGS. 14 through 16, one embodiment of set screw 10 of pedicle screw 100 is shown. Set Screw 10 defines a proximal opening 88 and an optional distal opening 90. Proximal opening 88 and distal opening 90 (if present) may form a single cavity extending through set screw 10 from a proximal end 92 to a distal end 94. Proximal end 92 includes an internal drive 96 in the form of an aperture that is illustrated in FIG. 15 as a starshaped internal drive such as that sold under the trademark TORX ®, or may be, for example, a hex drive, or other internal drives such as slotted, tri-wing, spanner, two or more apertures of various shapes, and the like. In yet other embodiments, internal drive 96 may be replaced with an external drive, such as a break-away portion. A driving tool (not shown) sized and shaped for engagement with internal drive 96 may be used for both rotatable engagement and, if needed, disengagement of set screw 10 for tulip head 4 at arms 38a and 38b. In one or more embodiments, set screw 10 may also optionally include a through bore 98 extending along a central axis of set screw 10 and through distal end 94. Through bore 98, if present, provides a passage through the single cavity of set screw 10 for interaction with instrumentation, such as a set screw driver (not shown). As shown in FIGS. 15 and 16, proximal end 92 of set screw 10 has a set screw upper diameter (Dgu), defined between twoQRT0060W0.0815823 points of the star-shaped internal drive 96 in FIG. 15, and a set screw lower diameter (DSL), defined between the edges of through bore 98 at distal end 94 in FIG. 16.

[0054] Set screw 10 further includes a set screw body 102 having an axis of rotation that may be the same as that of the tulip head 4 and includes a helically wound external thread structure 104 that operably joins with internal threads 42 of tulip head 4. Helically wound external thread structure 104 includes a start surface or structure 106, an end surface or structure 108, and a plurality of roots 41 and crests 43. Start structure 106 and end structure 108 work to operably guide set screw 10 under rotation to advance set screw 10 downward between arms 38a and 38b of tulip head 4. Helically wound thread structure 104, in some embodiments as shown herein, may be designed in such a manner as to resist splaying of arms 38a and 38b of tulip head 4 when set screw 10 is advanced into U-shaped channel 40 of tulip head 4. Set screw 10 may also be used with other implant devices such as bone anchors (e.g., pedicle screws, hooks, connectors, or the like to secure a connector rod, such as connector rod 10. An example of such an implant device is shown in FIG. 28 with a hook H.

[0055] When rotated, into tulip head 4 between arms 38a and 38b, start structure 106 of set screw 10 engages with internal threads 42 on one of said arms 38a or 38b. As rotated, helically wound thread structure 104 of set screw 10 advances axially downwardly between arms 38a and 38b until end structure 108 engages with internal threads 42. This downward rotation of set screw 10 may cause connector rod 12 to compress down into channel 80 of collet 6.

[0056] FIG. 17A shows a detailed embodiment of a portion of helically wound external thread structure 104 (e.g., a male thread (MT)) of some embodiments. As shown, this portion of the male thread MT shows multiple roots 41, a crest 43, Load Flank (LF) and Relief Flank (RF). As understood, the helically wound external thread structure 104 includes a plurality of crests 43 and a plurality of roots 41. In one or more embodiments, thread MT has a Load Flank Angle (LFA) less than or equal to 90°, a Relief Flank Angle (RFA) less than or equal to 90°, a Load Flank Crest Radius (LFCR) greater than or equal to 0.00 mm, and a Relief Flank Crest Radius (RFCR) of greater than or equal to 0.00 mm. In one or more embodiments, the dimensions of helically wound thread structure 104 discourage and / orQRT0060W0.0815823 mitigate unintended disengagement of set screw 10 from tulip head 4 during post-operations periods and during final tightening of set screw 10 into pedicle screw 100. In one or more embodiments, helically wound thread structure 104 may provide a mechanical interlock between set screw 10 and tulip head 4. In one or more embodiments, a sum of LFA and RFA may be less than 180° to yield a mechanical interlock. Therefore, in one or more embodiments, one of LFA or RFA may be greater than 90°, providing the other of RFA or LFA does not result in a sum of LFA and RFA being greater than 180°.

[0057] FIG. 17B shows a detailed embodiment of a portion of the internal threads 42 (e.g., a female thread (FT)) of some embodiments. As shown, the internal threads 42 (FT) shows multiple crests 43, a root 41, Load Flank (LF) and Relief Flank (RF). As understood, the internal thread structure 42 includes a plurality of crests 43 and a plurality of roots 41. In one or more embodiments, FT has an LFA less than or equal to 90°, an RFA less than or equal to 90°, an LFCR greater than or equal to 0.00 mm, and a RFCR of greater than or equal to 0.00 mm. In one or more embodiments, a sum of LFA and RFA may be less than 180° to yield a mechanical interlock. Therefore, in one or more embodiments, one of LFA or RFA may be greater than 90°, providing the other of RFA or LFA does not result in a sum of LFA and RFA being greater than 180°.

[0058] FIG. 17C shows a detailed embodiment of a portion of the internal threads 42 (e.g., a female thread (FT’)) of a tulip head of the present disclosure of some embodiments. As shown, the internal threads 42 (FT’) shows multiple crests43, a root 41, Load Flank (LF) and Relief Flank (RF). As understood, the internal thread structure 42 includes a plurality of crests 43 and a plurality of roots 41. In one or more embodiments, FT’ has an LFA less than or equal to 90° and an RFA of 90°. In one embodiment, FT’ has an LFA between 50° and 90°. In one embodiment, FT’ has an LFA of 82°. In one or more embodiments, a sum of LFA and RFA may be less than 180° to yield a mechanical interlock. FIG. 17D shows another detailed embodiment of a portion of the internal threads 42 (e.g., a female thread (FT”)) of a tulip head of the present disclosure of some embodiments. As shown, the internal threads 42 (FT”) shows multiple crests 43, a root 41, Load Flank (LF) and Relief Flank (RF). As understood, the internal thread structure 42 includes a plurality of crests 41 and a plurality of roots 41. In one or more embodiments, FT” has an LFA less than 90° and an RFA of greaterQRT0060W0.0815823 than 90°. In one embodiment, FT” has an LFA of 82° and an RFA of 95°. In one or more embodiments, a sum of LFA and RFA may be less than 180° to yield a mechanical interlock.

[0059] Although FIG. 17A focuses on the helically wound external thread structure 104 (i.e., the crest 43, LF, RF, LFA, and RFA), the same structure can apply to the internal threads 42 (i.e., FT including crest 43, LF, RF, LFA, and RFA). In a similar vein, although FIGS. 17B-D focuses on internal threads 42, the same structure can apply to helically wound external thread structure 104.

[0060] As used herein, the term dovetail thread is hereby defined to mean the combination of helically wound thread structure 104 on set screw 10 and internal threads 42 of tulip head 4. In one or more embodiments, dovetail thread may possess a flank angle (such as either LFA or RFA) that ensures the interlocking of helically wound thread structure 104 and internal threads 42, thereby creating a dovetail-shaped thread profile. In one or more embodiments, the flank angles, relative to a thread axis of either set screw 10 or tulip head 4, may be designed to achieve an interlocking engagement that may enhance load distribution across the mating surfaces between set screw 10 and tulip head 4.

[0061] In one or more embodiments, dovetail thread may be designed to resist axial displacement and prevent disengagement of helically wound thread structure 104 on set screw 10 and internal threads 42 of tulip head 4 under load. The interlocking nature of the thread flanks may provide increased shear resistance and ensure that the connection remains secure under dynamic conditions, including, but not limited to, vibration, thermal expansion, and mechanical stress.

[0062] In one or more embodiments, the load flank and relief flank, such as LF and RF as shown in FIG. 17 of helically wound external thread structure 104, work in tandem to ensure both a secure engagement and ease of assembly. Load flank, such as LF, bears the primary mechanical load, while relief flank, such as RF, may be optimized to prevent any unintended displacement or locking that could result in unintended decoupling between set screw 10 and tulip head 4. This combination may allow for a thread, such as MT, that is both strong and dependable under load, yet easy to assemble and dissemble as needed.QRT0060W0.0815823

[0063] In one or more embodiments, as external thread structure 104 of set screw 10, such as shown in FIG. 14, is screwed into internal threads 42 of tulip head 4, such as shown in FIG. 6, the wider crest, such as crest 43 as shown in FIG. 17 A, may come into close contact with ILF of internal threads 42 of tulip head 4. Due to the width of crest 43, it may effectively fill the space of the root 41 of internal threads 42 of tulip head 4, resulting in a tight fit. This tight fit between the crests and roots of mating set screw 10 and tulip head 4 may minimize any potential play or movement between mating set screw 10 and tulip head 4.

[0064] In one or more embodiments, the interlocking effect as discussed above may be further enhanced by the relationship between crest 43 and LFA. As the threads of set screw 10 are tightened, the width of crest 43 engages more firmly with root 41 of the threads of tulip head 4, creating a wedging effect. This wedging may not only secure the threads of mating set screw 10 and tulip head 4 together but may also make it more difficult for them to loosen under vibration or external forces, providing a self-locking characteristic. It is important to note that any action of the crests 43 of set screw 10 interacting with the roots 41 of tulip head 4 is also occurring with the crests 43 of tulip head 4 and the roots 41 of set screw 10.

[0065] In one or more embodiments, the crests, such as crest 43, of set screw 10, by virtue of its width, is designed to occupy and fill the spatial recesses created by the root, such as root 41, of the thread of the tulip head 4. The interstitial occupation effectuates a comprehensive contact surface, mitigating any potential axial or lateral displacement of the mating threads. The width of the crest, such as crest 43, impedes movement between the roots 41 of tulip head 4, thereby providing a firm and secure interlock.

[0066] In one or more embodiments, the present disclosure may be characterized by a thread profile wherein the crest, such as crest 43, defined as the uppermost planar surface of the male threads, exceeds the thread profile of the root, such as root 41, defined as the lowermost concave surface of the female threads, in lateral (e.g., radial) width. This dimensional relationship between the crests and roots of dovetail thread provides structural integrity and interlocking functionality for dovetail thread.

[0067] In one or more embodiments, the dimensional configurations of the crests andQRT0060W0.0815823 roots of dovetail thread, in conjunction with the load flank angles of the male threads, engenders a wedging effect upon the application of torque. This wedging effect creates a self-locking mechanism, wherein the broader crest of the male threads impinges upon the mating female threads, precluding inadvertent loosening or disengagement dure to vibratory forces or mechanical stress.

[0068] In one or more embodiments, congruent interactions of the crests and load flanks, when subjected to rotational torque, induces a wedging effect of such magnitude as to generate an intrinsic self-locking mechanism. This self-locking mechanism, arising from the enforced impingement of the crests of the male threads upon the geometry of the female threads, precludes involuntary loosening or disengagement, even under conditions of significant vibratory excitation or mechanical perturbation.

[0069] FIG. 18 shows one embodiment of locking lug 8 of pedicle screw 100. Locking lug 8 includes a lug body 110, a lug pocket wall 112, and lug pocket 114. Lug pocket 114 may be defined between portions of lug pocket wall 112. In use, once locking lug through hole 54 of tulip head 4 is aligned with lug cavity 84 of collet 6, locking lug 8 may be inserted into locking lug through hole 54 such that lug body 110 may be positioned within lug cavity 84 of collet 6. Once positioned, portions of lug pocket wall 112 may be peened to plastically deform the selected portions of lug pocket wall 112 to deform fully into through hole 54 of tulip head 4. In one or more embodiments, instead of peening portions of lug pocket wall 112, locking lug 8 may be secured through alternative methods such as a press fit, welding, brazing, threading, or other similar manners of securement.

[0070] Referring to FIGS. 19 through 23, one embodiment of a driving tool is shown. Driving tool 200 may be used to connect to a pedicle screw quickly and securely, such as pedicle screw 100, to drive the pedicle screw into position within a patient. As shown in at least FIG. 19, driving tool 200, in one or more embodiments, includes a driver 202, a spring retaining mechanism 204, a spring 206, and a retaining sleeve 208. Spring retaining mechanism 204 is shown as being an E-Clip, but other mechanisms are contemplated such as a C-clip, retaining ring, welded washer, or a threaded washer. Retaining sleeve 208 includes a spring housing 210 adjacent a proximal end 211 of retaining sleeve 208. Spring housingQRT0060W0.0815823210 houses spring 206 when driving tool 200 is in an unexploded state, such as shown in FIG. 20. Driver 202 may be placed through an aperture 213 at proximal end 211 of retaining sleeve 208 in spring housing 210 through the middle of spring 206 such that a driving end 212 of driver 202 may be positioned between two sleeve arms 214a and 214b adjacent a distal end 215 of retaining sleeve 208. Spring retaining mechanism 204 may be utilizable to hold driver 202 in position within retaining sleeve 208.

[0071] A compressive spring force between retaining sleeve 208 and driver 202 may default on the position of retaining sleeve to be in the Z+ direction as shown in FIG. 21. When depressing retaining sleeve 208, the force needed may be equivalent to the compressive spring force of spring 206. Spring retaining mechanism 204 may act as an axial constraint method for spring 206 to compress against when translating / depressing retaining sleeve 208 independently of driver 202.

[0072] To utilize driving tool 200, driving end 212 of driver 202 is aligned with driver receptacle 24 on spherical connector 16 of screw shank 2 as shown in FIG. 22. Retaining sleeve 208 may then be axially translated in the Z- direction such that engagement regions 216 on sleeve arms 214a and 214b are aligned within engagement regions 49 on arms 38a and 38b of tulip head 4 as shown in FIG. 23. In one or more embodiments, the engagement regions 216 are in the form of protrusions 216. Protrusions 216 and corresponding bump-outs 49 on arms 38a and 38b of tulip head 4 may be of other shapes, or entirely omitted, as long as a retaining force exerted by sleeve arms 214a and 214b of driving end 212 of driver 202 exceed the compressive spring force exerted, driving tool 200 will be engaged as intended. In one or more embodiments, arms 214a and 214b of retaining sleeve 208 includes spring slots 218 which splits each arm 214a, 214b into two finger portions 217a and 217b to allow for elastic deformation of retaining sleeve 208. The coupling force of retaining sleeve 208, once protrusions 216 are engaged with bump-outs 49 on arms 38a and 38b of tulip head 4, should be greater than the compressive spring force between retaining sleeve 208 and driver 202. If the coupling force is not greater than the compressive spring force, the compressive spring force may unintentionally decouple the pedicle screw, such as pedicle screw 100, from driving tool 200. After pedicle screw, such as pedicle screw 100, has been inserted into a patient, pulling up on retaining sleeve in the Z+ direction relative to driver 202 shouldQRT0060W0.0815823 disengage protrusions 216 from bump-outs 49, and the driving tool 200 can be disengaged from the inserted pedicle screw, such as pedicle screw 100.

[0073] FIG. 24 shows another embodiment of a driving tool. Similar to driving tool 200, driving tool 300 includes a driver 302, an E-Clip (not shown), a spring (not shown), and a retaining sleeve 308. Driving tool 300 also includes two sleeve arms 314a and 314b adjacent a distal end 315 of retaining sleeve 308. Sleeve arms 314a and 314b also include engagement regions 316. In one or more embodiments, engagement regions 316 take the form of protrusions 316. In order to keep protrusions 316 engaged, an additional member may be used to limit translation of retention sleeve 308. As shown in FIG. 24, a pin 320 may be utilized to keep protrusions 316 engaged. Pin 320 may translate independently of driver 302 and retaining sleeve 308 and may be configured in an internal or external configuration relative to retaining sleeve 308. If pin 320 is present, it would require disengagement prior to decoupling driving tool 300 from pedicle screw 100.

[0074] FIG. 25 shows another embodiment of a driving tool. Similar to driving tool 200 and 300, driving tool 400 includes a driver 402, an E-Clip (not shown), a spring (not shown), and a retaining sleeve 408. Driving tool 400 also includes two sleeve arms 414a and 414b adjacent a distal end 415 of retaining sleeve 408. Sleeve arms 414a and 414b also include engagement regions 416. In one or more embodiments, engagement regions 416 take the form of protrusions 416. In order to keep protrusions 416 engaged, an additional member may be used to limit translation of retention sleeve 408. As shown in FIG. 25, a sleeve 420 may be utilized to keep protrusions 416 engaged. Sleeve 420 may translate independently of driver 402 and retaining sleeve 408 and may be configured in an internal or external configuration relative to retaining sleeve 408. Sleeve 420 may be located between driver 402 and retaining sleeve 408 and may be sized as such to not allow translation of retaining sleeve 408 until disengaged in the Z+ direction. If sleeve 420 is present, it would require disengagement prior to decoupling driving tool 400 from pedicle screw 100.

[0075] FIG. 26 shows another embodiment of a driving tool. Similar to driving tool 200, 300, and 400, driving tool 500 includes a driver 502, and E-Clip (not shown), a spring 506, and a retaining sleeve 508. With driving tool 200, pulling up on retaining sleeve in the Z+ORT0060W0.0815823 direction relative to driver 202 should disengage protrusions 216 from bump-outs 49, and the driving tool 200 can be disengaged from the inserted pedicle screw, such as pedicle screw 100. With driving tool 500, button 522 may be depressed in order to decouple driving tool 500 from the inserted pedicle screw, such as pedicle screw 100.

[0076] FIG. 27 shows another embodiment of a driving tool. Similar to driving tool 200, 300, 400, and 500, driving tool 600 includes a driver 602, and E-Clip (not shown), a spring 606, and a retaining sleeve 608. With driving tool 200, pulling up on retaining sleeve in the Z+ direction relative to driver 202 should disengage protrusions 216 from bump-outs 49, and the driving tool 200 can be disengaged from the inserted pedicle screw, such as pedicle screw 100. With driving tool 600, sleeve 622 may be utilized in order to disengage protrusions of retaining sleeve 608 from bump-outs in a tulip head of a pedicle screw, such as bump-outs 49 of tulip head 4 of pedicle screw 100. In one embodiment, turning sleeve 622 a certain amount, such as a quarter-turn, would decouple driving tool 600.

[0077] In one or more embodiments, pedicle screw 100 must first be assembled before it may be inserted into a patient with one of the driving tools discussed above. In one embodiment, screw shank 2 may be held stationary, relief bore 39 of tulip head 4 may then be placed centrally relative to spherical connector 16 of screw shank 2 and tulip head 4 may also be held stationary. Collet 6 may then be placed into proximal opening 30 of tulip head 4. Using an assembly tool, collet 6 may then be pressed over spherical connector 16 such that fingers 76 of collet 6 elastically deform and grasp spherical connector 16. Position locking lug cavity 84 of collet 6 to be coplanar with an axis of locking lug through hole 54 of tulip head 4. Once positioned, insert locking lug 8 in through hole 54 of tulip head 4 such that a portion of lug body 110 may be within locking lug cavity 84. Once inserted, lug pocket 114 may be peened to plastically deform into a locked position. As discussed above, in some embodiment locking lug may be secured through a press fit, welding, brazing, threading, or other similar manners of securement. Pedicle screw 100 assembled according to the method discussed above would be considered a polyaxial pedicle screw 100 having a conical range of motion with a rotation point about the center of spherical connector 16 of screw shank 2.

[0078] In yet another embodiment of assembly, screw shank 2 may be held stationary,ORT0060W0.0815823 relief bore 39 of tulip head 4 may then be placed centrally relative to spherical connector 16 of screw shank 2 and tulip head 4 is held stationary. Collet 6 may then be placed into U- shaped channel 40 of tulip head 4. Using an assembly tool, collet 6 may then be pressed over spherical connector 16 such that fingers 76 of collet 6 elastically deform and grasp spherical connector 16. In an optional step, locking lug cavity 84 of collet 6 may be positioned to be coplanar with locking lug through hole 54 of tulip head 4. As an additional optional step if the previous optional step is undertaken, once positioned, locking lug 8 may be inserted in through hole 54 of tulip head 4 such that a portion of lug body 110 may be within locking lug cavity 84; and once inserted, lug pocket 114 may be peened to plastically deform into a locked position. Then, uni-pins 58a and 58b may be placed into tulip head uni-pin holes 56a and 56b, through uni-pin channels 86a and 86b in collet 6, and then into uni-pin holes 20a and 20b on spherical connector 16 of screw shank 2. Once uni-pins 58a and 58b are positioned, uni-pin peen holes 60a and 60b may be peened so as to displace the material of tulip head 4 positioned adjacent holes 60a and 60b, which may axially retain uni-pins 58a and 58b into position. As discussed above, in other embodiments tulip head 4 may not include uni-pin peen holes 60a and 60b, and uni-pins 58a and 58b may be secured through alternative methods such as a press fit, welding, brazing, threading, or other similar manners of securement. Set screw 100 assembled according to the method discussed above would be considered a uni-planar set screw 100 having a planar range of motion with a rotation point about the center of spherical connector 16 of screw shank 2

[0079] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additionalORT0060W0.0815823 features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0080] Example 1

[0081] A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at an proximal end of the screw shank; a tulip head having an proximal opening disposed in a proximal end of the tulip head, a distal opening disposed in a distal end of the tulip head opposite the proximal opening, and a pair of opposing arms, wherein at least one arm of the pair of opposing arms includes a locking lug through hole, each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent to the proximal opening, a compression inducing face adjacent to the distal opening, and adjacent the distal end of the tulip head are two uni-pin holes located on opposed sides circumferentially offset 180 degrees of one another; a collet having an upper collet portion and a lower collet portion, an proximal opening disposed in a proximal end of the collet, a distal opening disposed in a distal end of the collet opposite the proximal opening, and wherein the upper collet portion includes a pair of opposing arms, wherein at least one arm of the pair of opposing arms includes a locking lug cavity, the lower collet portion includes two uni-pin channels located on opposed sides circumferentially offset 180 degrees of one another, and the lower collet portion includes a plurality of fingers; and a set screw having an proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw.

[0082] Example 2

[0083] The pedicle screw of Example 1, wherein the connector of the screw shank includes two uni-pin holes located on opposed sides circumferentially offset 180 degrees of one another.

[0084] Example 3

[0085] The pedicle screw of Example 2, wherein when the uni-pin holes of the screw shank are aligned with the uni-pin channels of the collet and the uni-pin holes of the tulipORT0060W0.0815823 head, uni-pins are securable within the uni-pin holes of the screw shank, the uni-pin channels of the collet, and the uni-pin holes of the tulip head.

[0086] Example 4

[0087] The pedicle screw of Example 1, wherein a proximal end of the connector of the screw shank includes a driver receptacle.

[0088] Example 5

[0089] The pedicle screw of Example 1, wherein the proximal and distal openings of the tulip head form a cavity extending through the tulip head from the proximal end to the distal end.

[0090] Example 6

[0091] The pedicle screw of Example 5, wherein the pair of opposing arms of the tulip head define a channel transverse to the cavity of the tulip head, and wherein a connector rod is receivable within the tulip head channel.

[0092] Example 7

[0093] The pedicle screw of Example 1, wherein the proximal opening of the tulip head has a first diameter, the distal opening of the tulip head has a second diameter, and wherein the first diameter is larger than the second diameter.

[0094] Example 8

[0095] The pedicle screw of Example 1, wherein each arm of the pair of opposing arms of the tulip head has an external wall, and wherein each external wall includes an external tulip head pocket.

[0096] Example 9

[0097] The pedicle screw of Example 8, wherein each external tulip head pocket includes an upper wall with an undercut, two opposed side walls, a back wall, and a lower wall.ORT0060W0.0815823

[0098] Example 10

[0099] The pedicle screw of Example 1, wherein each arm of the pair of opposing arms of the tulip head has two side walls, and wherein each side wall includes an engagement region.

[0100] Example 11

[0101] The pedicle screw of Example 10, wherein each engagement region is utilizable to assist in securing a driving tool into position within the pedicle screw.

[0102] Example 12

[0103] The pedicle screw of Example 1 , wherein the proximal and distal openings of the collet form a cavity extending through the collet head from the proximal end to the distal end.

[0104] Example 13

[0105] The pedicle screw of Example 12, wherein the pair of opposing arms of the collet define a channel transverse to the cavity of the collet, and wherein a connector rod is receivable within the tulip head channel.

[0106] Example 14

[0107] The pedicle screw of Example 1, wherein the proximal opening of the collet has a first diameter, the distal opening of the collet has a second diameter, and wherein the first diameter is smaller than the second diameter.

[0108] Example 15

[0109] The pedicle screw of Example 14, wherein the fingers of the collet are expandable to elastically deform and grasp the connector of the screw shank.

[0110] Example 16

[0111] The pedicle screw of Example 1, wherein the set screw further includes a distalORT0060W0.0815823 opening disposed in a distal end of the set screw opposite the proximal opening.

[0112] Example 17

[0113] The pedicle screw of Example 16, wherein the proximal end of the set screw includes an internal drive and a through bore running from the proximal end to the distal end of the set screw.

[0114] Example 18

[0115] The pedicle screw of Example 1, wherein the helically wound thread structure includes a plurality of crests and a plurality of roots, and wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle.

[0116] Example 19

[0117] The pedicle screw of Example 17, wherein a sum of the load flank angle and the relief flank angle is less than 180 degrees.

[0118] Example 20

[0119] The pedicle screw of Example 1, wherein when the locking lug through hole is aligned with the locking lug cavity, a locking lug is securable within the locking lug through hole and the locking lug cavity

[0120] Example 21

[0121] A spinal fixation kit, the kit comprising: a pedicle screw according to Example 1 ; and a connector rod.

[0122] Example 22

[0123] The kit of Example 21, further comprising a bone anchor.

[0124] Example 23

[0125] The kit of Example 22, wherein the bone anchor is a second pedicle screw.ORT0060W0.0815823

[0126] Example 24

[0127] A spinal fixation system, the system comprising: a pedicle screw according to Example 1 ; and a connector rod.

[0128] Example 25

[0129] The spinal fixation system of Example 24, further comprising a bone anchor.

[0130] Example 26

[0131] The spinal fixation system of Example 25, wherein the bone anchor is a second pedicle screw.

[0132] Example 27

[0133] A method of assembling a pedicle screw, the method comprising: placing a connector of a screw shank within a tulip head; placing a collet into the tulip head through an proximal opening of the tulip head; pressing fingers of the collet over the connector of the screw shank with an assembly tool; positioning a locking lug cavity of the collet to be coplanar with a locking lug through hole of the tulip head; inserting a locking lug in through hole of tulip head such that a portion of the locking lug is within the locking lug cavity of the collet; and securing locking lug within locking lug cavity to form an assembled pedicle screw.

[0134] Example 28

[0135] The method of Example 27, wherein the step of step of assembling the pedicle screw further comprises: positioning uni-pin holes of the screw shank to be coplanar with uni-pin channels of the collet and uni-pin holes of the tulip head; inserting uni-pins through the uni-pin holes of the tulip head and through the uni-pin channels of the collet such that a portion of the uni-pins are within the uni-pin holes of the uni-pin holes of the screw shank; and securing the uni-pins.

[0136] Example 29ORT0060W0.0815823

[0137] The method of Example 28, wherein the step of securing the uni-pins includes peening uni-pin holes on the tulip head.

[0138] Example 30

[0139] The method of Example 28, wherein the step of securing the uni-pins includes press fitting, welding, brazing, or threading.

[0140] Example 31

[0141] The method of Example 28, wherein the step of securing the locking lug within the locking lug cavity includes peening, press fitting, welding, brazing, or threading.

[0142] Example 32

[0143] A method of non-threadingly engaging a driving tool into a pedicle screw, the method comprising: procuring the pedicle screw, wherein the pedicle screw comprises: a screw shank having a connector with a driving receptacle positioned at an proximal end of the screw shank; a tulip head a pair of opposing arms, wherein each arm of the pair of opposing arms has two side walls, and wherein each side wall includes an engagement region, a collet having a pair of opposing arms, wherein a lower collet portion includes a plurality of fingers; procuring the driving tool, wherein the driving tool comprises: a driver having a driving end, a spring, a retaining sleeve comprising a spring housing adjacent a proximal end of the retaining sleeve and two sleeve arms adjacent a distal end of the retaining sleeve wherein each sleeve arm includes a spring slot which splits each sleeve arm into two separate finger portions, and wherein each finger portion of each sleeve arm includes an engagement region, and a retaining mechanism; aligning the driving end of the driver of the driving tool with the driving receptacle on the connector of the screw shank; and translating the retaining sleeve of the driving tool such that the engagement regions on the sleeve arms of the retaining sleeve engage with the engagement regions on the tulip head.

[0144] Example 33

[0145] The method of Example 32, wherein the engagement regions on the sleeve arms are protrusions, and wherein the engagement regions on the tulip head are bump-outs.ORT0060W0.0815823

[0146] Example 34

[0147] A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at an proximal end of the screw shank; a tulip head having a pair of opposing arms, wherein each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent an proximal opening of the tulip head; a collet having an upper collet portion and a lower collet portion, wherein the lower collet portion includes a plurality of fingers; and a set screw having an proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw, wherein the proximal end of the set screw includes an internal drive, the helically wound thread structure includes a plurality of crests and a plurality of roots, and wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle, and a sum of the load flank angle and the relief flank angle is less than 180 degrees.

[0148] Example 35

[0149] The pedicle screw of Example 34, wherein the tulip head further includes a proximal opening disposed in a proximal end, a distal opening disposed in a distal end, a locking lug through hole on at least one arm of the pair of opposing arms, and a compression inducing face adjacent to the distal opening.

[0150] Example 36

[0151] The pedicle screw of Example 35, wherein the collet further includes a proximal opening disposed in a proximal end of the collet, a distal opening disposed in a distal end of the collet opposite the proximal opening, a pair of opposing arms included in the upper collet portion, a locking lug cavity in at least one arm of the pair of opposing arms, and two uni-pin channels located on opposed sides circumferentially offset 180 degrees of one another.

[0152] Example 37

[0153] The pedicle screw of Example 34, wherein the set screw further includes a distalORT0060W0.0815823 opening disposed in a distal end of the set screw opposite the proximal opening.

[0154] Example 38

[0155] The pedicle screw of Example 37, wherein the set screw further includes a through bore running from the proximal end to the distal end of the set screw.

[0156] Example 39

[0157] The pedicle screw of Example 34, wherein the connector of the screw shank includes two uni-pin holes located on opposed sides circumferentially offset 180 degrees of one another.

[0158] Example 40

[0159] The pedicle screw of Example 39, wherein when the uni-pin holes of the screw shank are aligned with the uni-pin channels of the collet and the uni-pin holes of the tulip head, uni-pins are securable within the uni-pin holes of the screw shank, the uni-pin channels of the collet, and the uni-pin holes of the tulip head.

[0160] Example 41

[0161] The pedicle screw of Example 37, wherein a proximal end of the connector of the screw shank includes a driver receptacle.

[0162] Example 42

[0163] The pedicle screw of Example 35, wherein the proximal and distal openings of the tulip head form a cavity extending through the tulip head from the proximal end to the distal end.

[0164] Example 43

[0165] The pedicle screw of Example 34, wherein the pair of opposing arms of the tulip head define a channel transverse to the cavity of the tulip head, and wherein a connector rod is receivable within the tulip head channel.ORT0060W0.0815823

[0166] Example 44

[0167] The pedicle screw of Example 34, wherein the proximal opening of the tulip head has a first diameter, the distal opening of the tulip head has a second diameter, and wherein the first diameter is larger than the second diameter.

[0168] Example 45

[0169] The pedicle screw of Example 34, wherein each arm of the pair of opposing arms of the tulip head has an external wall, and wherein each external wall includes an external tulip head pocket.

[0170] Example 46

[0171] The pedicle screw of Example 45, wherein each external tulip head pocket includes an upper wall with an undercut, two opposed side walls, a back wall, and a lower wall.

[0172] Example 47

[0173] The pedicle screw of Example 34, wherein each arm of the pair of opposing arms of the tulip head has two side walls, and wherein each side wall includes an engagement region.

[0174] Example 48

[0175] The pedicle screw of Example 47, wherein each engagement region is utilizable to assist in securing a driving tool into position within the pedicle screw.

[0176] Example 49

[0177] The pedicle screw of Example 36, wherein the proximal and distal openings of the collet form a cavity extending through the collet head from the proximal end to the distal end.

[0178] Example 50ORT0060W0.0815823

[0179] The pedicle screw of Example 36, wherein the pair of opposing arms of the collet define a channel transverse to the cavity of the collet, and wherein a connector rod is receivable within the tulip head channel.

[0180] Example 51

[0181] The pedicle screw of Example 36, wherein the proximal opening of the collet has a first diameter, the distal opening of the collet has a second diameter, and wherein the first diameter is equal to the second diameter.

[0182] Example 52

[0183] The pedicle screw of Example 34, wherein the fingers of the collet are expandable to elastically deform and grasp the connector of the screw shank.

[0184] Example 53

[0185] A spinal fixation kit, the kit comprising: a pedicle screw according to Example 34; and a connector rod.

[0186] Example 54

[0187] The spinal fixation kit of Example 53, further comprising a bone anchor.

[0188] Example 55

[0189] The spinal fixation kit of Example 54, wherein the bone anchor is a second pedicle screw.

[0190] Example 56

[0191] A driving tool for driving a pedicle screw into a vertebral body comprising: a driver having a driving end, a spring, a retaining sleeve comprising a spring housing adjacent a proximal end of the retaining sleeve and two sleeve arms adjacent a distal end of the retaining sleeve; and a retaining mechanism, wherein the spring housing houses the spring, wherein the driver is movably retained within the retaining sleeve by the retainingORT0060W0.0815823 mechanism such that the driving end is positioned within the two sleeve arms of the retaining sleeve.

[0192] Example 57

[0193] The driving tool of Example 56, wherein each sleeve arm includes a spring slot which splits each sleeve arm into two separate finger portions.

[0194] Example 58

[0195] The driving tool of Example 57, wherein each finger portion of each sleeve arm of the retaining sleeve includes an engagement region alignable with engagement regions on the pedicle screw.

[0196] Example 59

[0197] A spinal fixation kit, the kit comprising: a driving tool according to Example 56; and a bone anchor.

[0198] Example 60

[0199] The spinal fixation kit of Example 59, further comprising a connector rod.

[0200] Example 61

[0201] The spinal fixation kit of Example 59, wherein the bone anchor comprises a pedicle screw.

[0202] Example 62

[0203] A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at a proximal end of the screw shank; a tulip head having a proximal opening disposed in a proximal end of the tulip head, a distal opening disposed in a distal end of the tulip head opposite the proximal opening, and a pair of opposing arms, wherein at least one arm of the pair of opposing arms includes a locking lug through hole, each arm of the pair of opposing arms has an interior wall with internalQRT0060W0.0815823 threads disposed within each interior wall and adjacent to the proximal opening, and a compression inducing face adjacent to the distal opening; a collet having an upper collet portion and a lower collet portion, a proximal opening disposed in a proximal end of the collet, a distal opening disposed in a distal end of the collet opposite the proximal opening, and wherein the upper collet portion includes a pair of opposing arms, wherein the lower collet portion includes a plurality of fingers; and a set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw.

[0204] Example 63

[0205] A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at a proximal end of the screw shank; a tulip head having a pair of opposing arms, wherein each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent a proximal opening of the tulip head; and a set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw, wherein the proximal end of the set screw includes an internal drive, the helically wound thread structure includes a plurality of crests and a plurality of roots, and wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle, and a sum of the load flank angle and the relief flank angle is less than 180 degrees.

[0206] Example 64

[0207] A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at a proximal end of the screw shank; a tulip head having a pair of opposing arms, wherein each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent a proximal opening of the tulip head; and a set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw, wherein the helically wound thread structure includes a plurality of crests and a plurality of roots, andORT0060W0.0815823 wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle, and a sum of the load flank angle and the relief flank angle is less than 180 degrees.

[0208] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0209] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0210] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

ORT0060W0.0815823CLAIMS:

1. A set screw having a proximal opening disposed in a proximal end of the set screw and a helically wound thread structure located on an external surface of the set screw, wherein the proximal end of the set screw includes an internal drive, the helically wound thread structure includes a plurality of crest and a plurality of roots, and wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle, and a sum of the load flank angle and the relief flank angle is less than 180 degrees.

2. The set screw of claim 1, further comprising a distal opening disposed in a distal end of the set screw opposite the proximal opening.

3. The set screw of claim 2, further comprising a through bore running from the proximal end to the distal end of the set screw.

4. The set screw of claim 1, wherein the load flank angle is less than or equal to 90° and the relief flank angle is less than or equal to 90°.

5. The set screw of claim 1, wherein the load flank angle is less than or equal to 90° and the relief flank angle is equal to 90°.

6. The set screw of claim 1, wherein the load flank angle is less than 90° and relief flank angle is greater than 90°.

7. A pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at a proximal end of the screw shank; a tulip head having a pair of opposing arms, wherein each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent a proximal opening of the tulip head; andORT0060W0.0815823 a set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw, wherein the proximal end of the set screw includes an internal drive, the helically wound thread structure includes a plurality of crests and a plurality of roots, and wherein each crest of the plurality of crest has a load flank with a load flank angle and a relief flank with a relief flank angle, and a sum of the load flank angle and the relief flank angle is less than 180 degrees.

8. The pedicle screw of claim 7, wherein the tulip head farther includes a proximal opening disposed in a proximal end, a distal opening disposed in a distal end, a locking lug through hole on at least one arm of the pair of opposing arms, and a compression inducing face adjacent to the distal opening.

9. The pedicle screw of claim 8, wherein the pedicle screw further includes a collet having an upper collet portion and a lower collet portion, wherein the lower collet portion includes a plurality of fingers.

10. The pedicle screw of claim 9, wherein the collet further includes a proximal opening disposed in a proximal end of the collet, a distal opening disposed in a distal end of the collet opposite the proximal opening, a pair of opposing arms included in the upper collet portion, a locking lug cavity in at least one arm of the pair of opposing arms, and two unipin channels located on opposed sides circumferentially offset 180 degrees of one another.

11. The pedicle screw of claim 7, wherein the set screw further includes a distal opening disposed in a distal end of the set screw opposite the proximal opening.

12. The pedicle screw of claim 11, wherein the set screw farther includes a through bore running from the proximal end to the distal end of the set screw.QRT0060W0.081582313. The pedicle screw of claim 10, wherein the connector of the screw shank includes two uni-pin holes located on opposed sides circumferentially offset 180 degrees of one another.

14. The pedicle screw of claim 13, wherein when the uni-pin holes of the screw shank are aligned with the uni-pin channels of the collet and uni-pin holes of the tulip head, unipins are securable within the uni-pin holes of the screw shank, the uni-pin channels of the collet, and the uni-pin holes of the tulip head.

15. The pedicle screw of claim 7, wherein a proximal end of the connector of the screw shank includes a driver receptacle.

16. The pedicle screw of claim 8, wherein the proximal and distal openings of the tulip head form a cavity extending through the tulip head from the proximal end to the distal end.

17. The pedicle screw of claim 16, wherein the pair of opposing arms of the tulip head define a channel transverse to the cavity of the tulip head, and wherein a connector rod is receivable within the tulip head channel.

18. A universal pedicle screw comprising: a screw shank having a thread disposed along a length of the screw shank and a connector positioned at a proximal end of the screw shank; a tulip head having a proximal opening disposed in a proximal end of the tulip head, a distal opening disposed in a distal end of the tulip head opposite the proximal opening, and a pair of opposing arms, wherein at least one arm of the pair of opposing arms includes a locking lug through hole, each arm of the pair of opposing arms has an interior wall with internal threads disposed within each interior wall and adjacent to the proximal opening, a compression inducing face adjacent to the distal opening, and adjacent the distal end of the tulip head are two uni-pin holes located on opposed sides circumferentially offset 180 degrees of one another;ORT0060W0.0815823 a collet having an upper collet portion and a lower collet portion, a proximal opening disposed in a proximal end of the collet, a distal opening disposed in a distal end of the collet opposite the proximal opening, and wherein the upper collet portion includes a pair of opposing arms, wherein at least one arm of the pair of opposing arms includes a locking lug cavity, the lower collet portion includes two uni-pin channels located on opposed sides circumferentially offset 180 degrees of one another, and the lower collet portion includes a plurality of fingers; and a set screw having a proximal opening disposed in a proximal end of the set screw, and a helically wound thread structure joinable with the internal threads of the tulip head located on an external surface of the set screw.

19. The universal pedicle screw of claim 18, wherein the helically wound thread structure includes a plurality of crests and a plurality of roots, and wherein each crest of the plurality of crests has a load flank with a load flank angle and a relief flank with a relief flank angle.

20. The universal pedicle screw of claim 19, wherein a sum of the load flank angle and the relief flank angle is less than 180 degrees.

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