Bone fixation devices, systems, methods, and instruments

Abstract

The bone separation fastener may include a fastener shaft, a helical thread, and a bone staple. The helical thread may include a concave undercut surface oriented toward one end of the fastener shaft. The bone staple may include a first bone engaging feature, a second bone engaging feature, and an intermediate portion having an opening. The bone separation fastener may be implanted along the separation portion between the first and second bone portions. The concave undercut surface may be shaped to resist at least one force transmitted between the first and second bone portions to stabilize the separation. The first bone engaging feature may engage the first bone portion and the second bone engaging feature may engage the second bone portion to couple the bone staple to the bone portions and to resist at least one force transmitted between the bone portions to stabilize the separation.

Description

[Technical field]

[0001] The present disclosure relates to bone fixation devices, systems, methods, and instruments, and more particularly, to bone fixation devices, systems, methods, and instruments for stabilizing a disruption between two or more adjacent bones or bone portions, such as a bone junction, a fracture, a bone abutment, etc. [Background technology]

[0002] Surgical procedures involving fasteners implanted into bone to correct a separation between one or more bone portions may loosen over time due to multi-axial force and off-axis loading scenarios that may be applied to the fastener during the healing / fusion process. The thread design of conventional bone fasteners may not provide sufficient fixation to overcome these multi-axial force and off-axis loading scenarios.

[0003] Therefore, what is desired is a bone fixation fastener having an improved thread and compression design for increasing bone fixation and load sharing between the bone / fastener interface experiencing multiaxial and off-axis loading conditions. Summary of the Invention

[0004] The various bone fixation devices, systems, and methods of the present disclosure have been developed in response to the current state of the art, and in particular in response to problems and needs in the art that have not yet been fully addressed by currently available bone fixation devices, systems, and methods. In some embodiments, the bone fixation devices, systems, and methods of the present disclosure may provide improved bone fixation and load sharing between the bone / fastener interface under multiaxial and off-load conditions.

[0005] In some embodiments, the bone separation fastener may include a fastener shaft, a helical thread, and a bone staple. The fastener shaft may include a proximal end, a distal end, and a longitudinal axis. The helical thread may be disposed on the fastener shaft along the longitudinal axis and may include a concave undercut surface. The bone staple may include a first end including a first bone-engaging feature, a second end including a second bone-engaging feature, and an intermediate portion extending between the first and second ends. The intermediate portion may include an opening configured to receive the fastener shaft therethrough. In some embodiments, when the bone separation fastener is implanted along the separation between the first and second bone portions, a concave undercut surface is implanted along the separation between the first and second bone portions: the concave undercut surface is directed toward one of the proximal and distal ends of the fastener shaft; the concave undercut surface is formed to resist at least one force transmitted between the first and second bone portions to stabilize the dissection; the first bone engaging feature engages the first bone portion to couple a first end of the bone staple to the first bone portion and the second bone engaging feature engages the second bone portion to couple a second end of the bone staple to the second bone portion; the bone staple coupled to the first and second bone portions can resist at least one force transmitted between the first and second bone portions to stabilize the separation.

[0006] In some embodiments, the proximal end of the fastener shaft can include a fastener head.

[0007] In some embodiments, when the bone separation fastener is implanted along the separation between the first and second bone portions, the fastener head can engage an intermediate portion of the bone staple to couple the fastener shaft to the bone staple.

[0008] In some embodiments, the fastener head can include a first locking feature and the intermediate portion can include a second locking feature configured to engage the first locking feature and lock the fastener head to the bone staple.

[0009] In some embodiments, at least one of the first bone-engaging feature and the second bone-engaging feature may include at least one of one or more roughened surfaces, one or more teeth, one or more blades, one or more ribs, and one or more legs.

[0010] In some embodiments, the first bone-engaging feature can include a first leg that projects away from the first end of the bone staple along a first inferior direction and the second bone-engaging feature can include a second leg that projects away from the second end of the bone staple along a second inferior direction. The first inferior direction can be substantially parallel to the second inferior direction.

[0011] In some embodiments, the first bone engaging feature can include a first plurality of legs that project downwardly away from the first end of the bone staple, and the second bone engaging feature can include a second plurality of legs that project downwardly away from the second end of the bone staple.

[0012] In some embodiments, the bone separation fastener may include a compressible fastener shaft, a helical thread, and a compression system configured to move the compressible fastener shaft from a first uncompressed state to a second compressed state. The compressible fastener shaft may include a proximal end, a distal end, and a longitudinal axis. The helical thread may be disposed on the compressible fastener shaft along the longitudinal axis and may include a concave undercut surface. In some embodiments, when the bone separation fastener is implanted along a separation between a first bone portion and a second bone portion: the concave undercut surface may be oriented toward one of the proximal and distal ends of the compressible fastener shaft, the compression system may move the compressible fastener shaft from the first uncompressed state to the second compressed state, and the concave undercut surface may compress the first bone portion toward the second bone portion to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the separation.

[0013] In some embodiments, a compression system can include an inner bore formed in the compressible fastener shaft, at least one collet feature formed in the compressible fastener shaft about the inner bore, and a compression member configured to radially move the at least one collet feature toward a longitudinal axis of the compressible fastener shaft to move the compressible fastener shaft from a first uncompressed state to a second compressed state.

[0014] In some embodiments, the compression member may be removably coupleable to the compressible fastener shaft, and the compression member may engage a distal end of the compressible fastener shaft to radially move at least one collet feature and compress the compressible fastener shaft.

[0015] In some embodiments, the distal end of the compressible fastener shaft can include a first chamfered surface and the compression member can include a second chamfered surface that can engage the first chamfered surface to radially move the at least one collet feature and compress the compressible fastener shaft.

[0016] In some embodiments, the at least one collet feature can include one or more slots formed in the compressible fastener shaft.

[0017] In some embodiments, the bone separation fastener can also include a fastener head disposed at a proximal end of the compressible fastener shaft.

[0018] In some embodiments, the fastener head can include a concave shape configured to engage and longitudinally compress the first and second bone portions.

[0019] In some embodiments, the inner bore of the compressible fastener shaft may include internal threads and the compression member may include a compression member head and a compression member shaft configured to be received within the inner bore. The compression member shaft may include a proximal end, a distal end, and external threads disposed about the distal end of the compression member shaft. In some embodiments, when the compression member shaft is received within the inner bore of the compressible fastener shaft, the external threads of the compression member shaft may engage the internal threads of the compressible fastener shaft and the compression member head may radially compress the compressible fastener shaft to resist at least one force transmitted between the first and second bone portions and stabilize the separation.

[0020] In some embodiments, the bone separation fastener may include a first shaft, a first helical thread, and a bone plate. The first shaft may include a proximal end, a distal end, and a longitudinal axis. The first helical thread may be disposed on the first shaft along the longitudinal axis and may include a first concave undercut surface. The bone plate may include a first end including a first opening configured to receive the first shaft through the first bone portion, a second end including a bone engaging feature configured to couple the second end of the bone plate to the second bone portion, and an intermediate portion extending between the first end and the second end of the bone plate. In some embodiments, when the first shaft is implanted across the separation between the first and second bone portions, the first shaft may pass through the first opening of the bone plate, penetrate the first bone portion, and penetrate the second bone portion to stabilize the separation between the first and second bone portions.

[0021] In some embodiments, the bone engaging features may include at least one of one or more roughnesses, one or more teeth, one or more blades, one or more ribs, and one or more legs.

[0022] In some embodiments, the bone separation fastener can include a second shaft having a proximal end, a distal end, and a longitudinal axis, and a second helical thread disposed on the second shaft along the longitudinal axis having a second concave undercut surface.

[0023] In some embodiments, the second end of the bone plate can include a second opening configured to receive a second shaft therethrough.

[0024] In some embodiments of the bone separation fastener, when the second shaft is implanted across the separation between the first and second bone portions, the second shaft can pass through the second opening in the bone plate, pass through the second bone portion, and penetrate the first bone portion to stabilize the separation between the first and second bone portions.

[0025] In some embodiments, the intervertebral implant may include a shaft having a proximal end, a distal end, a longitudinal axis, and a minor axis, and a helical thread disposed on the shaft along the longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a concave undercut surface angled toward one of the proximal and distal ends of the shaft, and a major axis. In some embodiments, when the interbody implant is implanted in an intervertebral space between an upper vertebral body and an inferior vertebral body, the ratio of the major axis to the minor axis may be less than 1.5, and the concave undercut surface may engage the upper vertebral body and the inferior vertebral body, and the concave undercut surface may be shaped to resist at least one force transmitted between the upper vertebral body and the inferior vertebral body to stabilize the intervertebral space.

[0026] In some embodiments, at least one of the minor and major axes may be constant along at least a portion of the shaft.

[0027] In some embodiments, the shaft can include a cylindrical shape.

[0028] In some embodiments, the ratio of the major axis to the minor axis may be less than 1.25.

[0029] In some embodiments, the ratio of the major axis to the minor axis is less than 1.10.

[0030] In some embodiments, the ratio of the major axis to the minor axis may be less than 1.05.

[0031] In some embodiments, the shaft can include one or more passageways opening on opposite sides of the shaft adjacent the superior and inferior vertebral bodies and configured to receive bone reinforcements therein.

[0032] In some embodiments, the intervertebral implant may include a tapered shaft having a proximal end, a distal end, a longitudinal axis, and a minor axis, and a tapered helical thread disposed about the tapered shaft along the longitudinal axis between the proximal and distal ends of the tapered shaft. The tapered helical thread may include a concave undercut surface angled toward one of the proximal and distal ends of the tapered shaft, and a major axis. In some embodiments, when the intervertebral implant is implanted in an intervertebral space between an upper vertebral body and an inferior vertebral body, the concave undercut surface engages the upper vertebral body and the inferior vertebral body, and the concave undercut surface may be shaped to resist at least one force transmitted between the upper vertebral body and the inferior vertebral body to stabilize the intervertebral space.

[0033] In some embodiments, at least one of the minor and major diameters can vary along at least a portion of the tapered shaft.

[0034] In some embodiments, the tapered shaft can include an at least partially conical shape.

[0035] In some embodiments, at least a portion of the minor diameter can decrease from the proximal end of the tapered shaft to the distal end of the tapered shaft.

[0036] In some embodiments, at least a portion of the major dimension can decrease from the proximal end of the tapered shaft to the distal end of the tapered shaft.

[0037] In some embodiments, the tapered shaft can include one or more passageways that open on opposite sides of the shaft adjacent the superior and inferior vertebral bodies and are configured to receive bone reinforcement therein.

[0038] In some embodiments, the intervertebral implant can include one or more self-tapping features.

[0039] In some embodiments, a method of implanting an intervertebral implant within an intervertebral space between superior and inferior vertebral bodies can include: abutting a distal end of a shaft of the intervertebral implant against the intervertebral space, engaging a concave undercut surface of a helical thread disposed on the shaft with the superior and inferior vertebral bodies, and rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant into the intervertebral space. In some embodiments of the method, when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface can be shaped to resist at least one force transmitted between the superior and inferior vertebral bodies to stabilize the intervertebral space.

[0040] In some embodiments, the method may also include preparing the intervertebral space to receive the intervertebral implant. Preparing the intervertebral space may include at least one of removing at least a portion of the intervertebral disc intermediate the superior and inferior vertebral bodies, moving the superior and inferior vertebral bodies away from each other, and compressing the superior and inferior vertebral bodies toward each other.

[0041] In some embodiments, the method may also include forming at least one tapped bone screw in at least one of the superior vertebral endplate of the superior vertebral body and the inferior vertebral endplate of the inferior vertebral body.

[0042] In some embodiments of the method, the intervertebral implant can be a first intervertebral implant. The method can also include implanting a second intervertebral implant in the intervertebral space adjacent to the first intervertebral implant.

[0043] In some embodiments of the method, at least one of the minor diameter of the shaft and the major diameter of the helical thread may be constant along at least a portion of the shaft.

[0044] In some embodiments of the method, at least one of a minor diameter of the shaft and a major diameter of the helical thread may vary along at least a portion of the shaft.

[0045] In some embodiments, the bone separation instrument system can include a first bone pin having a first proximal end and a first distal end configured for fixation to a first bone portion, a second bone pin having a second proximal end and a second distal end configured for fixation to a second bone portion, and a guide block. The second bone portion can be disposed adjacent to the first bone portion and a bone separation can be formed intermediate the first and second bone portions. The guide block can include a first bone pin hole configured to receive the first bone pin therethrough, a second bone pin hole configured to receive the second bone pin therethrough, and a window formed through the guide block intermediate the first and second bone pin holes. The first bone pin can be fixed to the first bone portion and inserted through the first bone pin hole, and the second bone pin can be fixed to the second bone portion and inserted through the second bone pin hole. The first bone pin hole can provide a first force to the first bone pin along a first direction to compress or stretch the first bone portion relative to the second bone portion. The second bone pin hole can apply a second force along a second direction to the second bone pin to compress or distract the second bone portion relative to the first bone portion. The window can be configured to provide access for an implant placed therethrough to stabilize the bone separation during compression or distraction of the bone separation.

[0046] In some embodiments, the guide block can include at least one of a first lower lead-in feature formed for a first bone pin hole on the lower surface of the guide block, a second lower lead-in feature formed for a second bone pin hole on the lower surface of the guide block, a first upper lead-in feature formed for the first bone pin hole on the upper surface of the guide block, and a second upper lead-in feature formed for the second bone pin hole on the upper surface of the guide block.

[0047] In some embodiments, a first longitudinal axis of the first bone pin hole can be parallel to a second longitudinal axis of the second bone pin hole.

[0048] In some embodiments, the first and second bone pin holes may be spaced apart from one another by a first distance to compress the first and second bone portions toward one another when the first bone pin is secured to the first bone portion and inserted through the first bone pin hole and the second bone pin is secured to the second bone portion and inserted through the second bone pin hole.

[0049] In some embodiments, the first and second bone pin holes can be spaced apart from one another by a second distance to move the first and second bone portions away from one another when the first bone pin is secured to the first bone portion and inserted through the first bone pin hole and the second bone pin is secured to the second bone portion and inserted through the second bone pin hole.

[0050] In some embodiments, the first bone pin hole and the second bone pin hole may be spaced apart from each other by a third distance to hold the first bone portion and the second bone portion in a neutral position relative to each other when the first bone pin is secured to the first bone portion and inserted through the first bone pin hole and the second bone pin is secured to the second bone portion and inserted through the second bone pin hole.

[0051] In some embodiments, the bone separation instrument system may also include an insertion guide and a spade guide. The insertion guide may be configured to be at least partially received within the window, and the insertion guide may include a guide hole formed therethrough. The spade guide may include a spade portion at a distal end of the spade guide and a pin portion at a proximal end of the spade guide. The insertion guide may be at least partially receivable within the window, and the spade portion may be inserted into the bone separation between the first and second bone portions, and the pin portion may be inserted through the guide hole. The first bone pin hole may be configured to guide a first bone pin to the first bone portion along a first trajectory defined by an orientation of the pin portion relative to the guide hole, and the second bone pin hole may be configured to guide a second bone pin to the second bone portion along a second trajectory defined by an orientation of the pin portion relative to the guide hole.

[0052] In some embodiments, the bone separation instrument system may include a first bone pin having a first proximal end and a first distal end configured for fixation to a first bone portion, a second bone pin having a second proximal end and a second distal end configured for fixation to a second bone portion, a spade guide, an alignment block, and an implant insertion block. The second bone portion may be positioned adjacent to the first bone portion and a bone separation may be formed intermediate the first and second bone portions. The spade guide may include a spade portion at a distal end of the spade guide and a pin portion at a proximal end of the spade guide. The alignment block may include a first bone pin hole configured to receive the first bone pin therethrough, a second bone pin hole configured to receive the second bone pin therethrough, and an alignment block hole intermediate the first and second bone pin holes. The spade portion of the spade guide may be inserted into the bone separation between the first and second bone portions and the pin portion of the spade guide may be inserted through the alignment block hole. The first bone pin hole may be configured to guide the first bone pin to the first bone portion along a first trajectory defined by an orientation of the pin portion relative to the alignment block hole, and the second bone pin hole may be configured to guide the second bone pin to the second bone portion along a second trajectory defined by an orientation of the pin portion relative to the alignment block hole. The implant insert block may include a third bone pin hole, a fourth bone pin hole, and a window formed through the implant insert block intermediate the third and fourth bone pin holes. The first bone pin may be secured to the first bone portion and inserted through the third bone pin hole, and the second bone pin may be secured to the second bone portion and inserted through the fourth bone pin hole. The window may be configured to provide access for an implant to be placed through the window to stabilize the bone separation.

[0053] In some embodiments, the alignment block can include at least one of a first lower lead-in feature formed for a first bone pin hole on a lower surface of the alignment block, a second lower lead-in feature formed for a second bone pin hole on the lower surface of the alignment block, a first upper lead-in feature formed for the first bone pin hole on an upper surface of the alignment block, and a second upper lead-in feature formed for the second bone pin hole on the upper surface of the alignment block.

[0054] In some embodiments, a first longitudinal axis of the first bone pin hole can be parallel to a second longitudinal axis of the second bone pin hole.

[0055] In some embodiments, the spade portion can include a first substantially flat surface and a second substantially flat surface opposite the first substantially flat surface, The first substantially flat surface can be configured to engage a first surface of a first bone portion within the bone separation portion and the second substantially flat surface can be configured to engage a second surface of a second bone portion within the bone separation portion to indicate an orientation of the bone separation portion with the pin portion of the spade guide.

[0056] In some embodiments, the implant insertion block can include at least one of a first lower lead-in feature formed for a first bone pin hole on a lower surface of the implant insertion block, a second lower lead-in feature formed for a second bone pin hole on the lower surface of the implant insertion block, a first upper lead-in feature formed for the first bone pin hole on an upper surface of the implant insertion block, and a second upper lead-in feature formed for the second bone pin hole on the upper surface of the implant insertion block.

[0057] In some embodiments, the third bone pin hole can be parallel to the fourth bone pin hole.

[0058] In some embodiments, the first and second bone pin holes may be spaced apart from one another by a first distance to compress the first and second bone portions toward one another when the first bone pin is secured to the first bone portion and inserted through the first bone pin hole and the second bone pin is secured to the second bone portion and inserted through the second bone pin hole.

[0059] In some embodiments, a method of stabilizing a bone separation intermediate a first bone portion and a second bone portion may include compressing or distracting the bone separation and inserting an implant into the bone separation through a window formed in a guide block to stabilize the bone separation during compression or distraction of the bone separation. Compressing or distracting the bone separation may include inserting a proximal end of a first bone pin into a first bone pin hole of the guide block to apply a first force to the first bone pin along a first direction to compress or distract the first bone portion relative to the second bone portion, and inserting a proximal end of a second bone pin into a second bone pin hole of the guide block to apply a second force to the second bone pin along a second direction to compress or distract the second bone portion relative to the first bone portion.

[0060] In some embodiments, the method can also include inserting a spade portion of the spade guide into the bone separation, engaging a first surface of the first bone portion with the first substantially flat surface of the spade portion, and engaging a second surface of the second bone portion with the second substantially flat surface of the spade portion. The pin portion of the spade guide can extend away from the bone separation to indicate an orientation of the bone separation relative to the first and second bone portions.

[0061] In some embodiments, the method may also include positioning a first bone pin relative to the direction of bone distraction by inserting a distal end of a first bone pin into a first bone pin hole of the guide block and securing the distal end of the first bone pin to the first bone portion while the pin portion of the spade guide extends through a window formed in the guide block. The method may also include positioning a second bone pin relative to the direction of bone distraction by inserting a distal end of a second bone pin into a second bone pin hole of the guide block and securing the distal end of the second bone pin to the second bone portion while the pin portion of the spade guide extends through a window formed in the guide block.

[0062] In some embodiments, the guide block can comprise a first guide block, and compressing the bone separation can include inserting a proximal end of a first bone pin into a first bone pin hole of the first guide block to apply a first force to the first bone pin along a first direction to compress the first bone portion relative to the second bone portion, and inserting a proximal end of a second bone pin into a second bone pin hole of the first guide block to apply a second force to the second bone pin along a second direction to compress the second bone portion relative to the first bone portion.

[0063] In some embodiments, the guide block may include a second guide block, and distracting the bone separation may include inserting a proximal end of a first bone pin into a first bone pin hole of the second guide block to apply a first force to the first bone pin along a first direction to distract the first bone portion relative to the second bone portion, and inserting a proximal end of a second bone pin into a second bone pin hole of the second guide block to apply a second force to the second bone pin along a second direction to compress the second bone portion relative to the first bone portion.

[0064] In some embodiments, compressing the bone separation may include rotating the guide block to a first position and inserting a proximal end of the second bone pin into a convergent pin hole of the guide block to apply a compressive force to the bone separation, and distracting the bone separation may include rotating the guide block to a second position and inserting a proximal end of the second bone pin into an enlarged bone pin hole of the guide block to apply a distraction force to the bone separation.

[0065] These and other features and advantages of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the bone fixation devices, systems, and methods described hereinafter. [Brief description of the drawings]

[0066] Exemplary embodiments of the present disclosure will become more fully apparent from the following description taken in conjunction with the accompanying drawings, in which:

[0023] The exemplary embodiments of the present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings depict exemplary embodiments only, and therefore are not to be considered as limiting the scope of the present disclosure.

[0067] [Figure 1A] FIG. 1A is a front perspective view of a fastener according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is a rear perspective view of the fastener of FIG. 1A. [Figure 1C] FIG. 1C is a side view of the fastener of FIG. 1A. [Figure 1D] FIG. 1D is a cross-sectional side view of the fastener of FIG. 1C taken along line AA. [Diagram 2] FIG. 2 illustrates a partial cross-sectional side view of a crescent-threaded fastener according to one embodiment of the present disclosure. [Figure 3A] FIG. 3A is a perspective side view of a fastener according to another embodiment of the present disclosure. [Figure 3B] FIG. 3B is a cross-sectional side view of the fastener of FIG. 3A. [Figure 4] FIG. 4 is a cross-sectional side view of the fastener of FIG. 3A implanted in a bone joint. [Figure 5A] FIG. 5A shows an exploded perspective view of a fastener assembly according to another embodiment of the present disclosure. [Figure 5B] FIG. 5B shows a cross-sectional side view of the fastener assembly of FIG. 5A after assembly. [Figure 5C] FIG. 5C shows a perspective side view of the fastener assembly of FIG. 5A after assembly. [Figure 6A] FIG. 6A is a perspective side view of a fastener assembly according to another embodiment of the present disclosure. [Figure 6B] FIG. 6B is a perspective top view of the fastener assembly of FIG. 6A installed in a bone joint. [Figure 7A] FIG. 7A is a perspective side view of a fastener assembly according to another embodiment of the present disclosure. [Figure 7B] 7B is a perspective top view of the fastener assembly of FIG. 7A installed in a bone joint. [Figure 8A] FIG. 8A is a perspective side view of a fastener assembly according to another embodiment of the present disclosure. [Figure 8B] 8B is a perspective top view of the fastener assembly of FIG. 8A installed in a bone joint. [Figure 9A] FIG. 9A illustrates a top view of a distraction compression block according to one embodiment of the present disclosure. [Figure 9B] 9B shows various cross-sectional side views of the distraction compression block of FIG. 9A. [Figure 10] FIG. 10 illustrates a perspective top view of the distraction compression block of FIG. 9A coupled with one or more insertion guides. [Figure 11A] FIG. 11A is a perspective side view of a fastener assembly according to another embodiment of the present disclosure. [Figure 11B] FIG. 11B is a perspective side view of the fastener assembly of FIG. 11A having a locking feature. [Figure 12A] FIG. 12A illustrates a perspective top view of an alignment block, a distraction block, and a compression block, according to an embodiment of the present disclosure. [Figure 12B] FIG. 12B illustrates a bottom view of the alignment block, distraction block, and compression block of FIG. 12A. [Figure 13] FIG. 13 is a perspective side view of the compression block of FIG. 12A in combination with a guide tool. [Figure 14]FIG. 14 is a side view of a spade guide according to one embodiment of the present disclosure. [Figure 15A] FIG. 15A illustrates a perspective side view of an intervertebral fastener according to an embodiment of the present disclosure. [Figure 15B] FIG. 15B illustrates another perspective side view of the intervertebral fastener of FIG. 15A. [Figure 15C] FIG. 15C illustrates a side view of the intervertebral fastener of FIG. 15A. [Figure 15D] FIG. 15D illustrates a cross-sectional side view of the intervertebral fastener of FIG. 15A taken along line BB. [Figure 16A] FIG. 16A illustrates a perspective side view of an intervertebral fastener according to another embodiment of the present disclosure. [Figure 16B] FIG. 16B illustrates another perspective side view of the intervertebral fastener of FIG. 16A. [Figure 16C] FIG. 16C illustrates a side view of the intervertebral fastener of FIG. 16A. [Figure 16D] FIG. 16D illustrates a cross-sectional side view of the intervertebral fastener of FIG. 16A taken along line CC. [Figure 17] FIG. 17 is a perspective lateral view of a vertebra prior to surgery. [Figure 18] FIG. 18 is a perspective side view of the vertebral column of FIG. 17 with at least a portion of the intervertebral disc removed and one or more tapped bone screws formed in the superior and inferior vertebral bodies. [Figure 19] FIG. 19 shows the vertebral column of FIG. 18 with the intervertebral fastener of FIG. 15A positioned adjacent the prepared intervertebral space prior to insertion. [Figure 20] FIG. 20 shows the vertebral column of FIG. 19 with an intervertebral fastener inserted into the prepared intervertebral space. [Figure 21] FIG. 21 illustrates the vertebral column of FIG. 20 with a second intervertebral fastener inserted into the prepared intervertebral space adjacent to the first intervertebral fastener. [Figure 22] FIG. 22 is a perspective top view of an alignment block according to another embodiment of the present disclosure. [Diagram 23]FIG. 23 shows a perspective top view of a distraction block according to another embodiment of the present disclosure. [Figure 24] FIG. 24 is a perspective top view of a compression block according to another embodiment of the present disclosure.

[0068] It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and may not be drawn to scale. Further, the drawings depict illustrative embodiments and are not intended to represent limitations on the scope of the disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] Exemplary embodiments of the present disclosure are best understood by reference to the drawings, where like parts are designated with like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of embodiments of devices, systems and methods as represented in the drawings is not intended to limit the scope of the disclosure, but are merely representative of exemplary embodiments of the present disclosure.

[0070] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are illustrated in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0071] Standard medical and descriptive terminology is used herein, and although these terms are used generally to refer to the human body, certain terms are applicable to physical objects in general.

[0072] A standard system of three mutually perpendicular reference planes is employed: The sagittal plane divides the body into left and right. The coronal plane divides the body into anterior and posterior. The transverse plane divides the body into upper and lower halves. The midsagittal, midcoronal, or midtransverse planes divide the body into equal parts. The intersection of the sagittal and coronal planes defines the superior-inferior or cranial-caudal axis. The intersection of the sagittal and transverse planes defines the anterior-posterior axis. The intersection of the coronal and transverse planes defines the medial-lateral axis. The superior-inferior or cranial-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular.

[0073] Anterior means in front of the body. Posterior means behind the body. Superior or cephalad refers to the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of the body, especially toward either side of the body. Lateral means away from the midline of the body or away from either side of the body. Axial means toward the central axis of the body. Abaxial means away from the central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. Proximal means toward the trunk. Proximal can also mean toward the user or operator. Distal means away from the trunk. Distal can also mean away from the user or operator. Dorsal means toward the top of the foot. Plantar means toward the bottom of the foot. Varus means that the distal part of the leg from the knee down is deviated inwards, resulting in a bowed-leg appearance. Valgus means that the distal part of the leg from the knee down is deviated outwards, resulting in a buckled-knee appearance.

[0074] 1A-1D show various views of a bone screw, bone implant, implantable bone anchor, bone separation fastener, or fastener 100, in accordance with one embodiment of the present disclosure. Specifically, FIG. 1A is a front perspective view of fastener 100, FIG. 1B is a rear perspective view of fastener 100, FIG. 1C is a side view of fastener 100, and FIG. 1D is a cross-sectional side view of fastener 100 taken along line AA of FIG. 1C.

[0075] In general, fastener 100 may include a shaft 105 having a proximal end 101, a distal end 102, and a longitudinal axis 103. Fastener 100 may also include a head 104 located at the proximal end 101 of shaft 105, a torque connection interface 106 (in either a male / female configuration) formed in / on head 104, and a self-tapping feature 107 formed on the distal end 102 of shaft 105.

[0076] In some embodiments, the fastener 100 may include a first helical thread 110 disposed on the shaft 105 and a second helical thread 120 disposed on the shaft 105 adjacent to the first helical thread 110.

[0077] In some embodiments, the fastener 100 can include a “dual start” or “dual lead” thread configuration consisting of a first helical thread 110 and a second helical thread 120 .

[0078] In some embodiments, the depth of the first helical thread 110 and / or the second helical thread 120 relative to the shaft 105 can define a major axis relative to a minor axis of the shaft 105 alone.

[0079] In some embodiments, the major and / or minor diameters of fastener 100 may be constant or substantially constant along the entire length of the fastener or along a majority of the length of the fastener. In these embodiments, a constant minor diameter may help avoid blowout of narrow / delicate bone (e.g., pedicles) when inserting the fastener into the bone. In some embodiments, a pilot hole may be drilled into the narrow / delicate bone first, and then a fastener may be selected that has a similar minor diameter compared to the diameter of the pilot hole to avoid blowout when inserting the fastener into the bone.

[0080] In some embodiments, the depth of the first helical thread 110 and / or the second helical thread 120 relative to the shaft 105 may vary along the length of the shaft 105 to define one or more major axes of the fastener 100 and / or one or more regions along the fastener 100 may constitute one or more continuously variable major axes.

[0081] In some embodiments, the thickness of the shaft 105 may vary along the length of the shaft 105 to define one or more minor diameters of the fastener 100, and / or one or more regions along the fastener 100 may constitute one or more continuously variable minor diameters.

[0082] In some embodiments, the thickness / height / width / length / pitch / angle / shape, etc. of the first helical thread 110 and / or the second helical thread 120 (or any additional helical threads) may vary along the length of the shaft 105. For example, the thickness / height / width / length / pitch / angle / shape, etc. of the first helical thread 110 and / or the second helical thread 120 may be larger towards the tip of the fastener and smaller towards the head of the fastener (or vice versa), either in a discrete or continuously variable manner.

[0083] In some embodiments, the major and / or minor diameters may increase toward the proximal end or head of the fastener to increase bone compaction as the fastener is distally inserted into the bone / tissue.

[0084] In some embodiments, the pitch of the first helical thread 110 and / or the second helical thread 120 may vary along the length of the fastener 100.

[0085] In some embodiments, the fastener 100 may include multiple helical threads disposed about the shaft 105. However, it will be understood that any of the fasteners disclosed or contemplated herein may also include a single helical thread disposed about the shaft of the fastener. Additionally, the fastener 100 may include multiple nested helical threads having different lengths (not shown). As one non-limiting example, the fastener 100 may include a first helical thread 110 that is longer than a second helical thread 120 such that the fastener 100 comprises a dual thread along a first portion of the shaft 105 and a single thread along a second portion of the shaft 105.

[0086] In some embodiments, the multiple helical threads can include three helical threads of a "triple start" or "triple lead" thread configuration (not shown).

[0087] In some embodiments, the multiple helical threads may include four helical threads of a "quadruple start" or "quadruple lead" thread configuration (not shown).

[0088] In some embodiments, the multiple helical threads may include four or more helical threads (not shown).

[0089] In some embodiments, fastener 100 may include a first thread having any of the shapes disclosed herein oriented toward one of the proximal and distal ends of fastener 100, the first thread located adjacent to the distal end of fastener 100, and similarly, may include a second thread having any of the shapes disclosed herein oriented toward the other of the proximal and distal ends of fastener 100, the second thread located adjacent to a head (not shown) of fastener 100.

[0090] In some embodiments, fastener 100 may include multiple threads (e.g., a double helical thread, etc.) having any of the shapes disclosed herein located adjacent one of the proximal and distal ends of fastener 100, as well as a single thread having any of the shapes disclosed herein with a second thread located adjacent the other of the proximal and distal ends of fastener 100.

[0091] In some embodiments, the first helical thread 110 may include a plurality of first concave undercut surfaces 131 and a plurality of first convex undercut surfaces 141 .

[0092] In some embodiments, the second helical thread 120 may include a plurality of second concave undercut surfaces 132 and a plurality of second convex undercut surfaces 142 .

[0093] In some embodiments, when the fastener 100 is viewed in cross section along a plane intersecting the longitudinal axis 103 of the shaft 105 (see, for example, FIG. 1D ), the first concave undercut surfaces 131 and the second convex undercut surfaces 142 may face toward (i.e., face toward) the proximal end 101 of the shaft 105.

[0094] In some embodiments, the first plurality of convex undercut surfaces 141 and the second plurality of concave undercut surfaces 132 can be oriented toward (ie, facing) the distal end 102 of the shaft 105.

[0095] In some embodiments, at least one of the plurality of first concave undercut surfaces 131, the plurality of first convex undercut surfaces 141, the plurality of second concave undercut surfaces 132, and the plurality of second convex undercut surfaces 142 may be composed of at least one substantially flat surface.

[0096] In some embodiments, when the fastener 100 is viewed in cross section along a plane intersecting the longitudinal axis 103 of the shaft 105, the first helical thread 110 may be comprised of a plurality of first bent shapes (consisting of at least one surface at an angle to the longitudinal axis 103 of the shaft 105 and / or at least one undercut surface) having a plurality of first intermediate portions 151 facing (i.e., facing toward) the distal end 102 of the shaft 105. This may be referred to as a "standard" threading having a "standard" orientation.

[0097] In some embodiments, when the fastener 100 is viewed in cross section along a plane intersecting the longitudinal axis 103 of the shaft 105, the second helical thread 120 may be configured with a plurality of second bent shapes (consisting of at least one surface at an angle to the longitudinal axis 103 of the shaft 105 and / or at least one undercut surface) having a plurality of second intermediate portions 152 facing (i.e., facing toward) the proximal end 101 of the shaft 105. This may be referred to as a "reverse" thread having a "reverse" orientation.

[0098] In some embodiments, one or more helical threads may vary / transition between a standard orientation and a reversed orientation along the shaft of the fastener.

[0099] In some embodiments, at least one of the plurality of first concave undercut surfaces 131, the plurality of first convex undercut surfaces 141, the plurality of second concave undercut surfaces 132, and the plurality of second convex undercut surfaces 142 may be composed of at least one curved surface.

[0100] As shown in Figure 1D, the proximal and distal facing surfaces of first helical thread 110 (i.e., first concave undercut surface 131 and first convex undercut surface 141 in fastener 100 of Figure 1D) may not have mirror symmetry with respect to one another with respect to any plane perpendicular to longitudinal axis 103 of fastener 100. Rather, first concave undercut surface 131 and first convex undercut surface 141 may be generally parallel to one another. Similarly for second helical thread 120, second concave undercut surface 132 and second convex undercut surface 142 may not have mirror symmetry with respect to one another and may be generally parallel to one another.

[0101] Conversely, as also shown in FIGURE 1D, the proximally facing surface of the first helical thread 110 may have mirror symmetry with respect to the distally facing surface of the second helical thread 120. Specifically, the first concave undercut surface 131 may have mirror symmetry with respect to the second convex undercut surface 142 about a plane 170 that bisects the space between them and lies perpendicular to the longitudinal axis 103.

[0102] Similarly, the distally facing surface of the first helical thread 110 may have mirror symmetry with respect to the proximally facing surface of the second helical thread 120. Specifically, the second concave undercut surface 132 may have mirror symmetry with respect to the first convex undercut surface 141 about a plane 172 that bisects the space between them and lies perpendicular to the longitudinal axis 103.

[0103] This mirror symmetry may exist along the majority of the length of the first and second helical threads 110, 120, with symmetry across different planes disposed between adjacent turns of the first and second helical threads 110, 120 along the length of the longitudinal axis 103. Such mirror symmetry may aid in more effective capture of bone between the first and second helical threads 110, 120, and may also facilitate easier manufacture of the fastener 100.

[0104] In some embodiments, when fastener 100 is viewed in cross-section along a plane intersecting longitudinal axis 103 of shaft 105, first helical thread 110 can include at least one partial crescent shape facing (i.e., pointing toward) distal end 102 of shaft 105 and / or proximal end 101 of shaft 105. Figure 2 shows a partial cross-section of fastener 200 comprising a crescent shape as one non-limiting example of such an embodiment.

[0105] In some embodiments (not shown), when the fastener 100 is viewed in cross section along a plane intersecting the longitudinal axis 103 of the shaft 105, the first helical thread 110 may include at least one partial crescent shape that faces (i.e., faces toward) the distal end 102 of the shaft 105, and the second helical thread 120 may include at least one partial crescent shape that faces (i.e., faces toward) the proximal end 101 of the shaft 105.

[0106] In some embodiments (not shown), the first helical thread 110 may include a first plurality of partial crescent shapes that face (i.e., face toward) the distal end 102 of the shaft 105, and the second helical thread 120 may include a second plurality of partial crescent shapes that face (i.e., face toward) the proximal end 101 of the shaft 105.

[0107] In some embodiments (not shown), the first plurality of partial crescent shapes and the second plurality of partial crescent shapes may be arranged in alternating sequence along the shaft 105 of the fastener 100.

[0108] In some embodiments, the first helical thread 110 may be bisected by a line 123 shown in FIG. 2 similar to the helical thread shown in FIG. 1D , where each crescent shape includes a plurality of first undercut surfaces 111, a plurality of second undercut surfaces 112, a plurality of third undercut surfaces 113, and a plurality of fourth open surfaces 114, but with curved surfaces instead of flat surfaces.

[0109] In some embodiments, the first undercut surfaces 111 and the second undercut surfaces 112 may be comprised of concave curved surfaces. However, it will be understood that a portion of the first undercut surfaces 111 and / or a portion of the second undercut surfaces 112 may also be comprised of convex curved surfaces and / or flat surfaces (not shown in FIG. 2 ).

[0110] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may be comprised of convex curved surfaces. However, it will be understood that some of the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may also be comprised of concave curved surfaces and / or flat surfaces (not shown in FIG. 2 ).

[0111] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may be replaced by an inclined surface (as utilized in a standard buttress thread design) without an undercut (not shown in FIG. 2). Similarly, any of the other thread designs disclosed herein may utilize an inclined thread design or a buttress thread design on at least one side of the helical threads.

[0112] In some embodiments, the fasteners can have only standard threads or only reverse threads. The type of thread desired can depend on the type and / or magnitude of load applied to the fastener. For example, threads that are loaded axially away from the bone into which they are implanted can advantageously have standard threads, and threads that are loaded axially toward the bone into which they are implanted can advantageously have reverse threads. Threads that may experience polyaxial loading and / or unloading conditions can advantageously include at least one standard thread and at least one reverse thread to increase load sharing between the bone fixation and bone / fastener interface during polyaxial loading and unloading conditions, reduce high bone strains, and distribute polyaxial forces applied to the bone in a load sharing configuration rather than a load bearing configuration. Shear loads and / or bending moments can also be optimally resisted with any selected combination of threads, thread configurations, and / or thread variations contemplated herein to optimally resist shear loads, bending moments, polyaxial loads, off-load conditions, and the like.

[0113] In some embodiments, fasteners with standard threads can be used along with fasteners with reverse threads to accommodate different load patterns.

[0114] In some embodiments, a single fastener can have both standard and reverse threads, such as fastener 100. Such a combination of threads can help fastener 100 stay in place with unknown and / or changing load patterns.

[0115] In some embodiments, the thread profile of the fastener (standard and / or reverse threads) can be varied to adapt the fastener to a particular loading scheme. For example, the number of threads, the number of thread starts, the thread pitch, the thread lead, the thread profile, the thread-related dimensions (e.g., any length(s) / width(s) / height(s) / knee(s) associated with the thread, any dimension(s) associated with the thread ...

[0116] In some embodiments, the material(s) of any portion of the bone implants, joint replacement implants, fasteners, bone separation fasteners, etc. described herein may include, but are not limited to, metals (e.g., titanium, cobalt, stainless steel, etc.), metal alloys, plastics, polymers, ceramics, PEEK, UHMWPE, composites, additive particles, textured surfaces, biologics, biomaterials, bone, etc.

[0117] In some embodiments, any of the fasteners or implants described herein may include additional features, such as: self-tapping features, locking features (e.g., locking threads formed in a portion of the fastener, such as threads located on or near the head of the fastener), opening(s), cannulation(s), fenestration(s), any manner of fastener head (or no fastener head at all), any manner of torque connection interface (or no torque connection interface at all), etc.

[0118] In some embodiments, the openings, cannulas, bars, etc. formed in any of the fasteners or implants described herein may be configured to receive any suitable bone cement or bone augmentation material therein to promote bone ingrowth, bone fusion, etc.

[0119] In some embodiments, a tap (not shown) can be utilized to pre-form threads in the bone or bone reinforcement according to any thread profile disclosed or contemplated herein. As such, a tap having any suitable profile can be utilized with any fastener described or contemplated herein to match or substantially match the thread profile of a given fastener or bone implant.

[0120] In some embodiments, the minor diameter of the fastener can be selected to match or substantially match the diameter of the pilot hole formed in the bone to avoid bone blowout when the fastener is inserted into the pilot hole.

[0121] Additionally or alternatively, the thread type and / or thread geometry can be varied based on the type of bone the fastener is secured in. For example, fasteners secured in osteoporotic bone may perform better with standard or reverse threads, or if the pitch, major axis, and / or minor axis are increased or decreased, or the angle of the thread surface is adjusted, etc.

[0122] In some embodiments, the surgical kit may include multiple fasteners / implants having any of the different fastener / implant and screw options described or contemplated herein, and the surgeon may select the appropriate fastener / implant from the kit based on the particular load being applied and / or the quality of the bone into which the fastener / implant will be secured.

[0123] Continuing with FIG. 1D, in some embodiments, the first helical thread 110 can include a plurality of first undercut surfaces 111, a plurality of second undercut surfaces 112, a plurality of third undercut surfaces 113, and a plurality of fourth open surfaces 114.

[0124] In some embodiments, the second helical thread 120 may include a plurality of fifth undercut surfaces 125, a plurality of sixth undercut surfaces 126, a plurality of seventh undercut surfaces 127, and a plurality of eighth open surfaces 128.

[0125] In some embodiments, one or more of the plurality of first undercut surfaces 111, the plurality of second undercut surfaces 112, the plurality of third undercut surfaces 113, the plurality of fourth open surfaces 114, the plurality of fifth undercut surfaces 125, the plurality of sixth undercut surfaces 126, the plurality of seventh undercut surfaces 127, and the plurality of eighth open surfaces 128 may be comprised of at least one flat surface or a substantially flat surface.

[0126] In some embodiments, the first undercut surfaces 111, the third undercut surfaces 113, the sixth undercut surfaces 126, and the eighth open surfaces 128 may be angled toward the distal end 102 of the shaft 105.

[0127] In some embodiments, the plurality of second undercut surfaces 112, the plurality of fourth open surfaces 114, the plurality of fifth undercut surfaces 125, and the plurality of seventh undercut surfaces 127 may be angled toward the proximal end 101 of the shaft 105.

[0128] In some embodiments, when fastener 100 is viewed in cross-section along a plane intersecting longitudinal axis 103 of shaft 105 (as shown in FIG. 1D ), first helical thread 110 can include at least one chevron shape that faces toward (i.e., faces toward) the distal end 102 of shaft 105. Similarly, second helical thread 120 can also include at least one chevron shape that faces toward (i.e., faces toward) the proximal end 101 of shaft 105.

[0129] In some embodiments, when fastener 100 is viewed in cross-section along a plane intersecting longitudinal axis 103 of shaft 105 (as shown in FIG. 1D ), first helical thread 110 can include a first plurality of chevron shapes that face (i.e., point toward) distal end 102 of shaft 105. Similarly, second helical thread 120 can include a second plurality of chevron shapes that face (i.e., point toward) proximal end 101 of shaft 105.

[0130] In some embodiments, the first plurality of chevron shapes and the second plurality of chevron shapes may be arranged in alternating sequence along the shaft 105 of the fastener 100 (see, for example, FIG. 1D).

[0131] In some embodiments, a plurality of first interlocking spaces 161 and a plurality of second interlocking spaces 162 can be formed along the shaft 105 of the fastener 100 between the first helical thread 110 and the second helical thread 120 .

[0132] In some embodiments, a plurality of first interlocking spaces 161 may be formed intermediate the first concave undercut surface 131 and the second concave undercut surface 132 .

[0133] In some embodiments, a plurality of second interlocking spaces 162 may be formed intermediate the first convex undercut surface 141 and the second convex undercut surface 142 .

[0134] In some embodiments, the plurality of first interlocking spaces 161 may be larger in size than the plurality of second interlocking spaces.

[0135] In some embodiments, the plurality of first interlocking spaces 161 and the plurality of second interlocking spaces 162 may be shaped and / or configured to interlock with bone / other tissue received therein to increase fixation of the fastener 100 within the bone / other tissue and to provide additional resistance to multi-axial forces that may be applied to the fastener 100 and / or the bone / other tissue.

[0136] In some embodiments, the plurality of second undercut surfaces 112 and the plurality of sixth undercut surfaces 126 may be angled relative to one another to trap bone / bone reinforcing material within the plurality of first interlocking spaces 161 for increased fixation and resistance to multi-axial forces.

[0137] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of seventh undercut surfaces 127 may be angled relative to one another to capture bone / other tissue within the plurality of second interlocking spaces 162 to increase fixation and resistance to multi-axial forces.

[0138] In some embodiments, the first plurality of undercut surfaces 111 and the fifth plurality of undercut surfaces 125 may each form an angle α with respect to the longitudinal axis 103 of the shaft 105, as shown in FIG. 1D.

[0139] In some embodiments, the angle α may be greater than 90 degrees.

[0140] In some embodiments, the plurality of second undercut surfaces 112 and the plurality of sixth undercut surfaces 126 can each form an angle β with respect to the longitudinal axis 103 of the shaft 105 .

[0141] In some embodiments, the angle β may be less than 90 degrees.

[0142] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of seventh undercut surfaces 127 can each form an angle θ with respect to the longitudinal axis 103 of the shaft 105 .

[0143] In some embodiments, the angle θ may be about 90 degrees.

[0144] In some embodiments, the angle θ may be greater than 90 degrees.

[0145] It will be understood that any fastener / implant described or contemplated herein may include any thread configuration, feature, or form described or contemplated herein to achieve optimal fixation within a given bone / tissue. It will also be understood that any fastener / implant described or contemplated herein may be utilized with (or in) any system, method, or instrument described or contemplated herein.

[0146] 3A-4 show various views of a bone separation fastener or fastener 300 according to another embodiment of the present disclosure. Specifically, FIG. 3A is a perspective side view of fastener 300, FIG. 3B is a cross-sectional side view of fastener 300, and FIG. 4 is a cross-sectional side view of fastener 300 installed in a bone interface 400.

[0147] Generally, the fastener 300 may include a fastener shaft or shaft 305 having a proximal end 301, a distal end 302, and a longitudinal axis 303, as well as a head 304 disposed at the proximal end 301 of the shaft 305, and a helical thread 310 disposed about the shaft 305 along the longitudinal axis 303.

[0148] In some embodiments, the depth of the helical threads 310 relative to the shaft 305 can define a major axis relative to a minor axis of the shaft 305 alone.

[0149] In some embodiments, the major axis, minor axis, and / or pitch of the helical thread 310 is constant or substantially constant along the length of the fastener 300.

[0150] In some embodiments, the helical thread 310 can include one or more concave undercut surfaces 331 and / or one or more convex undercut surfaces 341 .

[0151] In some embodiments, the one or more concave undercut surfaces 331 may be angled toward one of the proximal end 301 and the distal end 302 of the shaft 305, and the one or more convex undercut surfaces 341 may be angled toward the other of the proximal end 301 and the distal end 302 of the shaft 305.

[0152] In some embodiments, the one or more concave undercut surfaces 331 may be angled toward the proximal end 301 of the shaft 305 and the one or more convex undercut surfaces 341 may be angled toward the distal end 302 of the shaft 305.

[0153] In some embodiments, the one or more concave undercut surfaces 331 and / or the one or more convex undercut surfaces 341 may include multiple flat surfaces that are angled with respect to one another.

[0154] In some embodiments, when the fastener 300 is implanted along the separation 405 between the first bone portion 401 and the second bone portion 402, the one or more concave undercut surfaces 331 can be formed to resist at least one force transmitted between the first bone portion 401 and the second bone portion 402 to stabilize the separation 405, as shown in FIG.

[0155] As used herein, the term "separation" between one or more bone portions may include a bone fracture, a bone gap, a bone crack, a bone fusion space, a bone abutment, and the like between one or more bone portions.

[0156] In some embodiments, the helical thread 310 can include one or more first undercut surfaces 311 and one or more second undercut surfaces 312 .

[0157] In some embodiments, the one or more first undercut surfaces 311 may be angled toward the proximal end 301 of the shaft 305, and the one or more second undercut surfaces 312 may be angled toward the distal end 302 of the shaft 305.

[0158] In some embodiments, the helical thread 310 may also include one or more third undercut surfaces 313 and one or more fourth open surfaces 314. However, it will be understood that in other embodiments, the one or more third undercut surfaces 313 and the one or more fourth open surfaces 314 may be replaced with any other shaped surface or surfaces (e.g., any buttress type thread form, any flat surface angled toward or away from the one or more concave undercut surfaces 331 or angled 90 degrees relative thereto, any curved surface generally oriented toward or away from the one or more concave undercut surfaces, etc.) without departing from the spirit or scope of the present disclosure. However, it will also be understood that the fastener 300 may (or may not) include any thread configuration, feature, or form described or contemplated herein for any fastener / implant to achieve optimal fixation within a given bone, tissue, bone cement, bone reinforcement material, etc. For example, in some embodiments, the helical threads 310 may be comprised of standard or reverse threads, a "dual start" thread configuration, a tapered helical thread, etc. It will further be understood that the fastener 300 may be utilized with (or within) any system, method, procedure, or instrumentation described or contemplated herein.

[0159] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include at least one chevron shape oriented toward one of the proximal end 301 and the distal end 302 of the shaft 305.

[0160] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include multiple chevron shapes oriented toward one of the proximal end 301 and distal end 302 of the shaft 305.

[0161] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include at least one partial crescent shape oriented toward the proximal end 301 or the distal end 302 of the shaft 305.

[0162] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include multiple partial crescent shapes oriented toward one of the proximal end 301 and distal end 302 of the shaft 305.

[0163] In some embodiments, when fastener 300 is implanted across or along a separation between two or more bones or bone portions (e.g., fractures, osteosynthesis, bone abutments, etc.), one or more concave undercut surfaces 331 may be oriented toward one of the proximal and distal ends 301, 302 of fastener 300 and one or more convex undercut surfaces 341 may be oriented toward the other of the proximal and distal ends 301, 302 of fastener 300. In this aspect, the unique shape and configuration of helical threads 310 may help to mitigate or prevent loosening of fastener 300 over time due to multi-axial force and off-axis loading scenarios that may be applied to fastener 300 along the separation during the healing process.

[0164] In some embodiments, one or more interlocking spaces 361 can be formed between adjacent threaded portions of the helical threads 310 along the shaft 305 of the fastener 300.

[0165] In some embodiments, one or more interlocking spaces 361 can be shaped and / or configured to interlock with the bone / other tissue received therein to increase fixation of the fastener 300 within the bone / other tissue and to provide additional resistance to multi-axial forces that may be applied to the fastener 300 and / or the bone / other tissue.

[0166] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include one or more bent shapes (including at least one surface at an angle to the longitudinal axis 303 of the shaft 305 and / or at least one undercut surface) having one or more intermediate portions 351 directed (i.e., pointed) toward one of the proximal end 301 and the distal end 302 of the shaft 305.

[0167] In some embodiments, at least one of the one or more concave undercut surfaces 331, the one or more convex undercut surfaces 341, the one or more first undercut surfaces 311, the one or more second undercut surfaces 312, the one or more third undercut surfaces 313, and / or the one or more fourth open surfaces 314 may be comprised of at least one substantially flat surface.

[0168] In some embodiments, at least one of the one or more concave undercut surfaces 331, the one or more convex undercut surfaces 341, the one or more first undercut surfaces 311, the one or more second undercut surfaces 312, the one or more third undercut surfaces 313, and / or the one or more fourth open surfaces 314 may be comprised of at least one curved surface.

[0169] 4, in some embodiments, when the fastener 300 is implanted along a separation 405 formed between a first bone portion 401 and a second bone portion 402 (e.g., implanted within a bone junction 400, a bone fracture, a bone abutment, etc.), the one or more first undercut surfaces 311 may be angled toward one of the proximal end 301 and the distal end 302 of the shaft 305 and the one or more second undercut surfaces 312 may be angled toward the other of the proximal end 301 and the distal end 302 of the shaft 305, and the first and second undercut surfaces may be configured to resist at least one force transmitted between the first bone portion 401 and the second bone portion 402 to stabilize the separation 405 between the first bone portion and the second bone portion.

[0170] In some embodiments, fastener 300 (or any other fastener / implant disclosed or contemplated herein) may be inserted across separation portion 405, along separation portion 405, and / or into the space defining separation portion 405 between two or more bone portions (or other anatomical structures) such that helical threads 310 engage the two or more bone portions (or other anatomical structures) radially relative to longitudinal axis 303 of fastener 300 to resist at least one force transmitted between the two or more bone portions during the healing process to stabilize separation portion 405.

[0171] In some embodiments, the one or more first undercut surfaces 311 may be angled toward the distal end 302 of the shaft 305, and the one or more second undercut surfaces 312 may be angled toward the proximal end 301 of the shaft 305.

[0172] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include at least one chevron shape oriented toward one of the proximal end 301 and the distal end 302 of the shaft 305.

[0173] In some embodiments, the helical thread 310 may include a number of chevron shapes oriented toward one of the proximal end 301 and the distal end 302 of the shaft 305 .

[0174] In some embodiments, when the fastener 300 is viewed in cross section along a plane intersecting the longitudinal axis 303 of the shaft 305, the helical thread 310 may include at least one partial crescent shape oriented toward one of the proximal end 301 and the distal end 302 of the shaft 305.

[0175] In some embodiments, the helical thread 310 may include a plurality of partial crescent shapes oriented toward one of the proximal end 301 and the distal end 302 of the shaft 305 .

[0176] In some embodiments, fastener 300 (or other fasteners / implants disclosed or contemplated herein) may be utilized to hold two or more bone portions, bone fragments, anatomical surfaces, etc. in position relative to one another, either temporarily or indefinitely.

[0177] For example, a compound or comminuted fracture may involve bone broken in multiple places, typically resulting in multiple fracture lines, bone fragments, comminuted bone portions, etc., resulting in multiple small bone fragments. Before a surgeon can apply definitive fixation to repair a compound fracture and promote healing in the correct orientation / position / shape, the bone fragments may need to be reduced or moved back into position and proximity relative to one another so that healing can ultimately occur in the correct orientation / position / shape. Conventional methods for reducing compound / crush fractures include conventional clamps, wires, pins, K-wires, bone screws, etc., to reduce compound / crush fractures until more definitive fixation (e.g., bone plates, intramedullary nails, etc.) is employed. However, the use of conventional clamps, wires, pins, K-wires, bone screws, etc., typically results in further bone loss, given the small, asymmetric bone fragments (poor surface) typically present in compound / crush fractures, and inserting these conventional instruments through the bone fragments leaves less intact bone for use during later / more definitive fixation.

[0178] In contrast, the fasteners / implants described or contemplated herein may be utilized within or along a bone separation to preserve bone by holding two or more bone portions relative to one another, with a helical thread form penetrating opposing surfaces of the bone portions and engaging with each bone portion to hold the bone portions in position relative to one another. In this manner, by placing the fasteners / implants directly into the separation, fracture, gap, etc., the bone portions may be preserved in volume and integrity and still provide additional space (and easier access to this additional space) for a conventional fixation fastener / implant to penetrate the bone portion to provide additional fixation in a temporary fixation stage and / or a later, more definitive fixation stage. The fasteners / implants described or contemplated herein may then be removed from the separation after the temporary reduction stage is completed, or may be left in place indefinitely, as desired. In this manner, the fasteners / implants described or contemplated herein may provide more efficient reduction, better space utilization to allow for additional bone fixation devices, and / or better stabilization of the bone portion as compared to conventional clamps, wires, pins, K-wires, bone screws, etc.

[0179] 6A-7B, 11A, and 11B, the fastener 300 may be combined with a bone staple or bone staple plate 610 to create a bone separation fastener or bone separation assembly 600 that may provide additional stability to the separation between two or more bone portions.

[0180] In some embodiments, the bone staple plate 610 may include a bridge 620 having a first end 621, a second end 622, and an intermediate portion 625 extending between the first end 621 and the second end 622 of the bridge 620.

[0181] In some embodiments, the intermediate portion 625 can include an opening or aperture 626 configured to receive the shaft 305 of the fastener 300 therein.

[0182] In some embodiments, the openings 626 can be configured to engage the heads 304 of the fasteners 300 to couple the bone staple plate 610 to the fasteners 300 .

[0183] In some embodiments, the opening 626 and / or the head 304 may each be comprised of partial spherical shapes that may be smooth, molded, or otherwise configured to engage with one another and provide multi-axial fixation of the head 304 relative to the opening 626 (see, e.g., FIG. 11A).

[0184] In some embodiments, the head 304 may include a first locking feature 308 (e.g., a first locking screw, as one non-limiting example) and the intermediate portion 625 or the opening 626 may include a second locking feature 608 (e.g., a second locking screw, as one non-limiting example) that may be configured to engage with one another to lock the head 304 of the fastener 300 to the bone staple plate 610 (see, e.g., FIG. 11B ). However, it will be understood that any manner of locking feature may be utilized with the fasteners / implants described or contemplated herein without departing from the spirit or scope of the present disclosure.

[0185] In some embodiments, the head 304 can include a locking feature and the opening 626 can include a non-locking feature (eg, a smooth partial spherical shape, as one non-limiting example).

[0186] In some embodiments, head 304 may include a non-locking feature (eg, a smooth partial spherical shape, as one non-limiting example) and opening 626 may include a locking feature.

[0187] In some embodiments, the first end 621 can include a first bone-engaging feature and the second end 622 can include a second bone-engaging feature.

[0188] In some embodiments, at least one of the first bone-engaging feature and the second bone-engaging feature may be comprised of at least one of one or more roughnesses, one or more teeth, one or more blades, one or more ribs, and one or more legs.

[0189] In some embodiments, the bone staple plate 610 may include a first leg 631 that protrudes away from the first end 621 of the bridge 620 along a first downward direction and a second leg 632 that protrudes away from the second end 622 of the bridge 620 along a second downward direction.

[0190] In some embodiments, the first downward direction can be substantially parallel to the second downward direction.

[0191] In some embodiments, when the fastener 300 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the head 304 of the fastener 300 can engage with the intermediate portion 625 of the bridge 620 to couple the fastener 300 and / or the shaft 305 of the fastener 300 to the bone staple plate 610.

[0192] In some embodiments, when the fastener 300 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the first bone engagement feature can engage the first bone portion 401 to connect the first end 621 of the bone staple plate 610 to the first bone portion 401.

[0193] In some embodiments, when the fastener 300 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the second bone engagement feature can engage the second bone portion 402 to connect the second end 622 of the bone staple plate 610 to the second bone portion 402.

[0194] In some embodiments, when the fastener 300 is implanted along a separation 405 formed between the first bone portion 401 and the second bone portion 402, the bone staple plate 610 coupled to the first bone portion 401 and the second bone portion 402 can resist at least one force transmitted between the first bone portion 401 and the second bone portion 402 to stabilize the separation 405.

[0195] In some embodiments, when the fastener 300 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the first leg 631 of the bone staple plate 610 can penetrate the first bone portion 401 to couple the bone staple plate 610 to the first bone portion 401, and the second leg 632 of the bone staple plate 610 can penetrate the second bone portion 402 to couple the bone staple plate 610 to the second bone portion 402.

[0196] In some embodiments, the bone staple plate 610 may further include a third leg 633 that protrudes away from the first end 621 of the bridge 620 along a third downward direction, and a fourth leg 634 that protrudes downwardly away from the second end 622 of the bridge 620 along a fourth downward direction (see, for example, FIG. 7A ).

[0197] In some embodiments, the first recessive direction, the second recessive direction, the third recessive direction, and / or the fourth recessive direction can be substantially parallel to one another.

[0198] In some embodiments, the distal surface of the bridge 620 can be contoured / curved to match the contour of the bone.

[0199] In some embodiments, the bone staple plate 610 can provide improved rotational stability and the fastener 300 can provide bending stability of the bone separation fastener or bone separation assembly 600.

[0200] In some embodiments, the bone staple plate 610 may include a first leg 631 that protrudes away from the first end 621 of the bridge 620 along a first inferior direction, and the second end 622 of the bridge 620 may include one or more attachment features (not shown).

[0201] In some embodiments, the one or more attachment features can be configured to engage the second bone portion 402 to couple the bone staple plate 610 to the second bone portion 402 .

[0202] In some embodiments, the one or more attachment features may comprise a roughened surface (not shown) configured to engage with the second bone portion 402 to secure the second end 622 of the bridge 620 to the second bone portion 402 via a friction fit.

[0203] In some embodiments, the one or more attachment features may include a blade (not shown) configured to engage the second bone portion 402 to secure the second end 622 of the bridge 620 to the second bone portion 402.

[0204] In some embodiments, the one or more attachment features may include one or more ribs (not shown) configured to engage the second bone portion 402 to secure the second end 622 of the bridge 620 to the second bone portion 402.

[0205] In some embodiments, the one or more attachment features may comprise one or more teeth (not shown) configured to engage the second bone portion 402 to secure the second end 622 of the bridge 620 to the second bone portion 402.

[0206] In some embodiments, the one or more attachment features may include a second leg 632 configured to penetrate the second bone portion 402 to couple the bone staple plate 610 to the second bone portion 402.

[0207] In some embodiments, the first leg 631 may be comprised of a first plurality of legs projecting downwardly away from the first end 621 of the bridge 620, and the second leg 632 may be comprised of a second plurality of legs projecting downwardly away from the second end 622 of the bridge 620.

[0208] In some embodiments, the first and second pluralities of legs can project substantially parallel to one another.

[0209] 8A and 8B, the bone separation fastener or bone separation assembly 800 may generally be comprised of a first bone separation fastener, a second bone separation fastener, and a bone plate or bone separation plate 810. The bone separation assembly 800 may utilize a cross-fastener design to stabilize the separation 405 between two or more bone portions.

[0210] In some embodiments, the first bone separation fastener and / or the second bone separation fastener may comprise a fastener similar to fastener 300 discussed previously herein.

[0211] In some embodiments, the bone separation plate 810 may include a bridge 820 having a first end 821 including a first opening or first opening 831 that may be configured to engage a first head of a first bone separation fastener, a second end 822 including a second opening or second opening 832 that may be configured to engage a second head of a second bone separation fastener, and an intermediate portion 825 that may extend between the first end 821 and the second end 822 of the bridge 820.

[0212] In some embodiments, the first end 821 and / or the second end 822 may include at least one bone engaging feature configured to couple with the first bone portion 401 and / or the second bone portion 402.

[0213] In some embodiments, the at least one bone engaging feature may include at least one of one or more roughnesses, one or more teeth, one or more blades, and one or more ribs, and one or more legs.

[0214] In some embodiments, when the bone separation release assembly 800 is implanted across the separation 405 formed between the first bone portion 401 and the second bone portion 402, a first bone separation fastener can pass through a first opening 831 in the bridge 820, pass through the first bone portion 401, and penetrate into the second bone portion 402. Similarly, a second bone separation fastener can pass through a second opening 832 in the bridge 820, pass through the second bone portion 402, and enter the first bone portion 401 to stabilize and / or compress the separation 405 between the first and second bone portions.

[0215] In some embodiments, the bone separation plate 810 can be contoured / curved to match the contours of the bone.

[0216] In some embodiments, a first bone separation fastener can form a first angle with respect to the bone separation plate 810 and a second bone separation fastener can form a second angle with respect to the bone separation plate 810.

[0217] In some embodiments, the first angle and the second angle may be congruent to one another.

[0218] In some embodiments, the first angle and the second angle may be non-aligned with each other.

[0219] In some embodiments, the first angle and the second angle may be selected such that an intersection point between the first and second bone separation fasteners may reside within a selected one of the first bone portion 401, the second bone portion 402, and the separation portion 405. In this manner, one or more stress concentrations that may occur at the intersection point may be selectively located within the first bone portion 401, the second bone portion 402, and / or the separation portion 405 to ameliorate the effect of the one or more stress concentrations, as desired.

[0220] 5A-5C, bone separation fastener or bone separation assembly 500 can include a split fastener, compressible fastener shaft, or bone separation fastener 508 that can be coupled to a fastener insert, compression member, or insert member 550 to form a compression system configured to move the compressible fastener shaft from a first uncompressed state to a second compressed state.

[0221] In some embodiments, the bone separation fastener 508 may include a compressible fastener shaft or fastener shaft 505 with a proximal end, a distal end, a longitudinal axis, an inner bore 515 within the fastener shaft 505, and at least one collet feature 520 that may be configured to allow the fastener shaft 505 to compress radially and / or longitudinally.

[0222] In some embodiments, the bone separation fastener 508 may also include a fastener head 504 disposed at a proximal end of the fastener shaft 505 and a helical thread 510 disposed about the fastener shaft 505 along the longitudinal axis.

[0223] In some embodiments, the helical thread 510 can include at least one concave undercut surface oriented toward one of the proximal and distal ends of the fastener shaft 505 .

[0224] In some embodiments, the insert member 550 can include a compression member shaft or insert shaft 555 configured to be received within the inner bore 515 of the fastener shaft 505 .

[0225] In some embodiments, the insertion shaft 555 can include a proximal end, a distal end, a longitudinal axis, and a compression member head or insertion head 554 disposed at the proximal end of the insertion shaft 555 .

[0226] In some embodiments, the compression system can include an inner bore 515 formed in the compressible fastener shaft, at least one collet feature 520 formed in the compressible fastener shaft about the inner bore 515, and a compression member configured to move the at least one collet feature 520 radially toward a longitudinal axis of the compressible fastener shaft to move the compressible fastener shaft from a first uncompressed state to a second compressed state.

[0227] In some embodiments, the compression member may be removably coupleable to the compressible fastener shaft, and the compression member may engage a distal end of the compressible fastener shaft to radially move at least one collet feature and compress the compressible fastener shaft.

[0228] In some embodiments, when the bone separation fastener 508 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the compression system can move the compressible fastener shaft from a first uncompressed state to a second compressed state.

[0229] In some embodiments, when the bone separation fastener 508 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the insertion head 554 can engage the distal end of the fastener shaft 505 and compress the fastener shaft 505 along at least one of the radial and longitudinal directions.

[0230] In some embodiments, when the bone separation fastener 508 is implanted along a separation 405 formed between the first bone portion 401 and the second bone portion 402, the fastener head 504 can engage and compress the outer surfaces of the first and second bone portions across the separation 405 along a first direction.

[0231] In some embodiments, when the bone separation fastener 508 is implanted along a separation 405 formed between the first bone portion 401 and the second bone portion 402, at least one concave undercut surface of the helical thread 510 can engage and compress at least one inner surface between the first bone portion 401 and the second bone portion 402 to resist at least one force transmitted between the first bone portion 401 and the second bone portion 402 across the separation 405 along a second direction substantially opposite to the first direction to stabilize the separation.

[0232] In some embodiments, when the bone separation fastener 508 is implanted along the separation 405 formed between the first bone portion 401 and the second bone portion 402, the concave undercut surface can compress the first bone portion 401 toward the second bone portion 402 to resist at least one force transmitted between the first bone portion 401 and the second bone portion 402 to stabilize the separation 405.

[0233] In some embodiments, the distal end of fastener head 504 can include a concave shape or surface 509 .

[0234] In some embodiments, the distal end of the fastener shaft 505 can include a first chamfered surface 561 .

[0235] In some embodiments, the distal end of the insertion head 554 can include a second chamfered surface 562 .

[0236] In some embodiments, the second chamfered surface 562 of the insertion head 554 can be configured to engage the first chamfered surface 561 of the fastener shaft 505 and radially move at least one collet feature 520 and compress the fastener shaft 505 along at least one of the radial and / or longitudinal directions.

[0237] In some embodiments, the first chamfered surface 561 may comprise a convex surface.

[0238] In some embodiments, the second chamfered surface can comprise a concave surface.

[0239] In some embodiments, the at least one collet feature 520 may consist of one or more slots formed in the fastener shaft 505 along the longitudinal axis of the fastener shaft 505 .

[0240] In some embodiments, the inner diameter bore can include internal threads 571 .

[0241] In some embodiments, the insertion shaft can include outer threads 572 configured to engage inner threads 571 of inner bore 515 to couple insertion member 550 to bone separation fastener 508 and compress fastener shaft 505 along at least one of radial and longitudinal directions. In this manner, insertion head 554 can compress a distal portion of fastener shaft inwardly such that fastener head 504 compresses bone beneath its concave surface 509 toward at least one undercut surface while at least one undercut surface oriented toward fastener head 504 compresses bone toward fastener head 504, as shown in FIG. 5B. In this manner, bone separation assembly 500 utilizes a positive compressive force to increase fixation and stabilize separation portion 405.

[0242] In some embodiments, the outer surfaces of the first and second bone portions across the separation can be shaped with a suitable tool (not shown) to include a mating shape that corresponds to the concave surface 509 of the fastener head 504.

[0243] In some embodiments, the concave surface 509 of the fastener head 504 may be configured to bring the two bone portions together when the bone separation assembly 500 is attached to the separation portion 405 and tightened.

[0244] In some embodiments, at least one concave undercut surface of the helical thread 510 can be configured to bring the two bone portions together when the bone separation assembly 500 is attached to the separation portion 405 and tightened.

[0245] 9A-10 show various views of a bone separation instrument system that may include a first bone pin 921, a second bone pin 922, and a distraction compression block 900, according to one embodiment of the present disclosure. The distraction compression block 900 may also be referred to herein as a guide block, a placement block, or an implant insertion block. FIGS. 9A and 9B show a top view of the distraction compression block 900, FIG. 9B shows various cross-sectional side views of the distraction compression block 900, and FIG. 10 shows a perspective top view of the distraction compression block 900 with one or more insertion guides 950.

[0246] In some embodiments, the first bone pin 921 may include a first proximal end 931 (see, e.g., FIG. 13) and a first distal end 941 configured for fixation to a first bone portion (such as the first bone portion 401 shown in FIG. 4), and the second bone pin 922 may include a second proximal end 932 and a second distal end 942 configured for fixation to a second bone portion (such as the second bone portion 402 shown in FIG. 4). The second bone portion may be disposed adjacent to the first bone portion, and a bone separation may be formed intermediate the first and second bone portions.

[0247] In some embodiments, the distraction-compression block 900 can be configured to assist in the preparation and fusion of bone separations (osteosynthesis, bone fractures, etc.) during a surgical procedure by utilizing the distraction-compression block 900 in combination with a first bone pin 921 and a second bone pin 922 to distract the bone separation during surface preparation, and then compress the bone separation (and / or hold the bone separation under compression), and attach an appropriate implant to the bone separation to fixate / fuse the bone separation.

[0248] In some embodiments, the distraction compression block 900 may include a first bone pin hole or holes 901, one or more second bone pin holes (e.g., parallel pin holes 911, enlarged pin holes 912, and converging pin holes 913), a window or central opening 940 formed through the distraction compression block 900 intermediate the first pin hole 901 and the one or more second bone pin holes, and a locking feature 930.

[0249] In some embodiments, the parallel pin holes 911, the enlarging pin holes 912, and the converging pin holes 913 may be arranged along a circle 960 to allow for easy rotation of the distraction compression block 900 between successive steps of the surgical procedure.

[0250] In some embodiments, the longitudinal axes of the first pin hole 901 and the parallel pin hole 911 may be substantially parallel to one another in the general orientation.

[0251] In some embodiments, the longitudinal axis or distal end of the enlarged pin hole 912 may be enlarged away from the longitudinal axis of the first pin hole 901 in the general orientation.

[0252] In some embodiments, the longitudinal axis or distal end of the converging pin hole 913 may converge toward the longitudinal axis of the first pin hole 901 in the general orientation.

[0253] In some embodiments, the first bone pin 921 may be longer than the second bone pin 922 .

[0254] In some embodiments, a first bone pin 921 may be inserted into a first bone portion on a first side of a bone separation (e.g., a bone fracture, a bone fusion, such as separation 405 shown in FIG. 4). The first bone pin 921 may then be inserted into a first pin hole 901 of the distraction compression block 900. A second bone pin 922 may then be inserted through a parallel pin hole 911 of the distraction compression block 900 into a second bone portion on a second side of the bone fusion.

[0255] In some embodiments, the distraction compression block 900 can then be slid over the first bone pin 921 and off the shorter second bone pin 922.

[0256] In some embodiments, the distraction compression block 900 can then be rotated to the "2DIST" or enlarged pin hole 912 position and slid over the second bone pin 922 again. Because the distal end of the distraction pin hole 912 is distracted away from the first pin hole, distraction of the bone joint occurs as the distraction compression block 900 slides down over the first and second bone pins toward the joint. Additionally, the further the distraction compression block 900 is slid over the first and second bone pins toward the joint, the more distraction compression can be achieved.

[0257] In some embodiments, a locking feature 930 (such as a cam or a frictional surface finish inside the first pin hole 901) can be utilized to hold the distraction compression block 900 in place on the first and second bone pins to maintain the desired distraction position.

[0258] In some embodiments, while the joint is held in the desired distraction position, the bone surfaces on both sides of the joint can be accessed and prepared for fixation / fusion. After this bone preparation step is completed, the locking feature 930 can be released and the distraction-compression block 900 can be slid back to release the second bone pin 922 from the distraction pin hole 912.

[0259] In some embodiments, the distraction compression block 900 can then be rotated to the "3COM" or converging pin hole 913 and the second bone pin 922 can be inserted therein. Because the distal end of the converging pin hole 913 converges towards the first pin hole 901, compression occurs as the distraction compression block 900 slides down the first and second bone pins towards the joint. Additionally, the further the distraction compression block 900 is slid down the first and second bone pins towards the joint, the more compression can be achieved.

[0260] In some embodiments, a locking feature 930 may then be utilized to hold the distraction compression block 900 in place over the first and second bone pins to maintain the desired compressed position.

[0261] In some embodiments, the desired compressed position may be maintained while subsequent steps of the surgical procedure are performed (e.g., fixation steps including, but not limited to, drilling, tapping, inserting an implant, etc.).

[0262] In some embodiments, the distraction compression block 900 can also include one or more insertion guides 950. In some embodiments, the one or more insertion guides 950 can include one or more guide holes 970 formed therethrough.

[0263] In some embodiments, one or more insertion guides 950 may be at least partially received or inserted within the central opening 940 and / or positioned directly over the joint to guide placement of a preliminary guide pin or spade guide 1400 (see, e.g., FIG. 14 ) to ensure proper joint orientation before the first bone pin 921 is inserted into the first bone portion, as described in more detail below with reference to FIGS. 12A-14 .

[0264] In some embodiments, one or more insertion guides 950 can also be utilized to facilitate other steps in a surgical procedure, such as guides for drilling, tapping, inserting implants, and the like.

[0265] In some embodiments comprising bone staples, bone plates, or any other additional implant structures described or contemplated herein, one or more insertion guides 950 may be configured to accommodate placement of these structures through the window and / or around the distraction-compression block 900 while the joint is held in a desired compressed or distracted position.

[0266] In some embodiments, when a first bone pin 921 is secured to a first bone portion and inserted through the first pin hole 901 and a second bone pin 922 is secured to a second bone portion and inserted through the converging pin hole 913, the first pin hole 901 can impart a first force to the first bone pin 921 along a first direction toward the converging pin hole 913 to compress the first bone portion toward the second bone portion. Similarly, the converging pin hole 913 can impart a second force to the second bone pin 922 along a second direction toward the first pin hole 901 to compress the second bone portion toward the first bone portion. In this aspect, the window or central opening 940 can be configured to provide access for an implant (e.g., any of the implants disclosed or contemplated herein) to be placed in / adjacent to the bone separation through the central opening 940 to stabilize, fixate, or fuse the bone separation via an implant placed in / adjacent to the bone separation while the bone separation is under compression (or distraction).

[0267] As used herein, the terms "stabilize" or "stabilizing" may include long-term or short-term stabilization of a bone separation via one or more implants (and / or implant devices) implanted in or near one or more bones or bone portions that make up the bone separation.

[0268] In some embodiments, when a first bone pin 921 is secured to a first bone portion and inserted through the first pin hole 901 and a second bone pin 922 is secured to a second bone portion and inserted through the enlarged pin hole 912, the first pin hole 901 can impart a first force to the first bone pin 921 along a first direction away from the enlarged pin hole 912 to move the first bone portion away from the second bone portion. Similarly, the enlarged pin hole 912 can impart a second force to the second bone pin 922 along a second direction away from the first pin hole 901 to move the second bone portion away from the first bone portion. In this manner, the window or central opening 940 can be configured to provide access for an implant (e.g., any of the implants disclosed or contemplated herein) to be placed into the bone separation through the central opening 940 while the bone separation is under distraction (or compression) to stabilize the bone separation.

[0269] 12A-14 show various components for one or more bone distraction instrument systems according to embodiments of the present disclosure. Specifically, FIGs. 12A and 12B show perspective top and bottom views of a guide block, implant insertion block, or placement block 1000, a guide block, implant insertion block, or distraction block 1100, and a guide block, implant insertion block, or compression block 1200 according to embodiments of the present disclosure. FIG. 13 shows a perspective side view of the compression block 1200 of FIG. 12A in combination with a guide tool 1300, and FIG. 14 shows a side view of a spade guide 1400.

[0270] The alignment block 1000, the distraction block 1100, and / or the compression block 1200 may also be referred to herein as blocks, guide blocks, or implant insertion blocks.

[0271] The positioning block 1000, distraction block 1100, and compression block 1200 may be configured to assist in the preparation and fusion of a bone separation (osteosynthesis, bone fracture, etc.) during a surgical procedure by utilizing each block in combination with the first and second bone pins 921 and 922. By utilizing each block in combination with the first and second bone pins 921 and 922, during a surgical procedure, the following can be done: place the first and second bone pins 921 and 922 on either side of the bone separation, distract the bone separation during surface preparation, then compress the bone separation (and / or hold the bone separation under compression), and place an appropriate implant (e.g., any of the implants described or contemplated herein) into the bone separation to stabilize / fix / fuse the bone separation.

[0272] In some embodiments, the alignment block 1000 may include a first bone pin hole 1011, a second bone pin hole 1012, an alignment block hole or window 1040, an upper surface 1050, a lower surface 1060, a first lower introduction feature 1061, a second lower introduction feature 1062, a first upper introduction feature 1051, and a second upper introduction feature 1052.

[0273] As defined herein, the term "lead-in feature" may include any shape or structure proximate a bone pin hole that may be formed through any guide block disclosed or contemplated herein to facilitate or guide the insertion of one or more bone pins into the bone pin hole. For example, lead-in features may include, but are not limited to, chamfered edges having any shape or size (e.g., circular chamfered edge, conical elliptical chamfered edge, parabolic chamfered edge, etc.), bone pin holes having two or more radii / shapes, etc.

[0274] In some embodiments, the distraction block 1100 may include a first bone pin hole 1111, a second bone pin hole 1112, a distraction block hole or window 1140, an upper surface 1150, a lower surface 1160, a first lower introduction feature 1161, a second lower introduction feature 1162, a first upper introduction feature 1151, and a second upper introduction feature 1152.

[0275] In some embodiments, the compression block 1200 may include a first bone pin hole 1211, a second bone pin hole 1212, a compression block hole or compression block window 1240, an upper surface 1250, a lower surface 1260, a first lower lead-in feature 1261, a second lower lead-in feature 1262, a first upper lead-in feature 1251, and a second upper lead-in feature 1252.

[0276] In some embodiments, the compression block window 1240 and one or more of the first and second bone pin holes 1211, 1212 may be joined together as shown in Figures 12A and 12B. However, it will be understood that the windows of any guide block disclosed or contemplated herein may be of any shape, size, configuration, etc. Additionally, the windows of any guide block disclosed or contemplated herein may be bounded completely or partially by one or more side walls of the guide block.

[0277] In some embodiments, each of the alignment block 1000, the distraction block 1100, and the compression block 1200 may (or may not) include a locking function (not shown), as described earlier in this specification with respect to Figures 9A-10.

[0278] In some embodiments, when a first bone pin 921 is secured to a first bone portion and inserted through a first bone pin hole 1211 of the compression block 1200 and a second bone pin 922 is secured to a second bone portion and inserted through a second bone pin hole 1212 of the compression block 1200, the first bone pin hole 1211 can impart a first force to the first bone pin 921 along a first direction toward the second bone pin hole 1212 to compress the first bone portion toward the second bone portion. Similarly, the second bone pin hole 1212 can impart a second force to the second bone pin 922 along a second direction toward the first bone pin hole 1211 to compress the second bone portion toward the first bone portion. In this manner, the compression block window 1240 can be configured to provide access for an implant (e.g., any of the implants disclosed or contemplated herein) to be placed into the bone separation through the compression block window 1240 while the bone separation is under compression to stabilize the bone separation.

[0279] In some embodiments, when a first bone pin 921 is secured to a first bone portion and inserted through a first bone pin hole 1111 of the distraction block 1100 and a second bone pin 922 is secured to a second bone portion and inserted through a second bone pin hole 1112 of the distraction block 1100, the first bone pin hole 1111 may impart a first force to the first bone pin 921 along a first direction away from the second bone pin hole 1112 to move the first bone portion away from the second bone portion. Similarly, the second bone pin hole 1112 may impart a second force to the second bone pin 922 along a second direction away from the first bone pin hole 1111 to move the second bone portion away from the first bone portion. In this manner, the distraction block window 1140 can be configured to provide access for an implant (e.g., any of the implants disclosed or contemplated herein) to be placed through the distraction block window 1140 into the bone separation while the bone separation is under distraction to stabilize the bone separation.

[0280] In some embodiments, the longitudinal axes of the first bone pin hole 1211 and the second bone pin hole 1212 of the compression block 1200 may be substantially parallel to each other in a general orientation. However, it will be appreciated that the longitudinal axes of the first bone pin hole 1211 and the second bone pin hole 1212 of the compression block 1200 may diverge from each other and / or converge towards each other.

[0281] In some embodiments, the longitudinal axes of the first bone pin hole 1111 and the second bone pin hole 1112 of the distraction block 1100 may be substantially parallel to each other in a general orientation. However, it will be appreciated that the longitudinal axes of the first bone pin hole 1111 and the second bone pin hole 1112 of the distraction block 1100 may diverge from each other and / or converge towards each other.

[0282] In some embodiments, the longitudinal axes of the first bone pin hole 1011 and the second bone pin hole 1012 of the placement block 1000 may be substantially parallel to each other in a general orientation. However, it will be appreciated that the longitudinal axes of the first bone pin hole 1011 and the second bone pin hole 1012 of the placement block 1000 may diverge from each other and / or converge towards each other.

[0283] In some embodiments, each of the bone pin holes formed in each of the guide blocks of FIGS. 12A - 12B may be linear slot-shaped and / or parallel to each other. However, these parallel bone pin holes can also be selectively spaced apart from each other to create a desired compressive force, tensile force, and / or neutral position (e.g., no tensile force at all) between the first bone pin 921 and the second bone pin 922. In these embodiments, the bone pin holes can also include introduction features around the bone pin holes (the lower surface of the block, the upper surface of the block, or both, as previously described herein) to assist in facilitating the insertion of the first and second bone pins into the bone pin holes.

[0284] In some embodiments, the first bone pin hole 1211 and the second bone pin hole 1212 of the compression block 1200 may be spaced apart from each other by a first distance 1271 to compress the first bone portion and the second bone portion toward each other when the first bone pin 921 is secured to the first bone portion and inserted through the first bone pin hole 1211 and the second bone pin 922 is secured to the second bone portion and inserted through the second bone pin hole 1212.

[0285] In some embodiments, when the first bone pin 921 is fixed to the first bone portion and inserted through the first bone pin hole 1111 and the second bone pin 922 is fixed to the second bone portion and inserted through the second bone pin hole 1112, the first bone pin hole 1111 and the second bone pin 922 are fixed to the second bone portion and inserted through the second bone pin hole 1112, the first bone pin hole 1111 and the second bone pin hole 1112 of the extension block 1100 may be spaced apart from each other by a second distance 1172 to space the first bone portion and the second bone portion apart from each other.

[0286] In some embodiments, the first bone pin hole 1011 and the second bone pin hole 1012 of the alignment block 1000 may be spaced apart from each other by a third distance 1073 to hold the first bone portion and the second bone portion in a neutral position relative to each other when the first bone pin 921 is secured to the first bone portion and inserted through the first bone pin hole 1011 and the second bone pin 922 is secured to the second bone portion and inserted through the second bone pin hole 1012.

[0287] 14 is a side view of a spade guide 1400 according to one embodiment of the present disclosure. The spade guide 1400 may generally include a spade portion 1410 at a distal end of the spade guide 1400 and a pin portion 1420 at a proximal end of the spade guide 1400.

[0288] In some embodiments, the spade portion 1410 can be inserted into a bone separation (fracture, osteosynthesis, etc.). In this aspect, the pin portion 1420 of the spade guide 1400 can generally indicate a longitudinal or optimal fastener / implant trajectory for the bone separation / articulation based on the spade portion 1410 placed within the bone separation.

[0289] In some embodiments, the spade portion 1410 can include a first substantially planar surface 1411 and a second substantially planar surface 1412 opposite the first substantially planar surface 1411 .

[0290] In some embodiments, a first substantially flat surface 1411 of the spade portion 1410 may be configured to engage a first surface of a first bone portion within the bone separation (see, e.g., first surface 411 in FIG. 4 ), and a second substantially flat surface 1412 of the spade portion 1410 may be configured to engage a second surface of a second bone portion within the bone separation (see, e.g., second surface 412 in FIG. 4 ), which may be configured to engage and indicate the orientation of the bone separation via a pin portion 1420 of the spade guide 1400 that protrudes away from the bone separation along the orientation of the bone separation.

[0291] In some embodiments, the pin portion 1420 of the spade guide 1400 may be received through the alignment block window 1040 of the alignment block 1000 to guide the initial placement of the first and second bone pins 921, 922 into the bone portions via the first and second bone pin holes 1011, 1012 of the alignment block 1000. However, in other embodiments, the windows of the distraction block 1100 and / or compression block 1200 may be configured to receive one or more insertion guides (not shown) having functionality similar to the one or more insertion guides 950 shown in FIG. 10. In this aspect, the pin portion 1420 of the spade guide 1400 may be utilized in combination with the distraction block 1100 and / or compression block 1200 to direct the placement of the first and second bone pins 921, 922 relative to the bone separation, with the alignment block 1000 omitted.

[0292] In some embodiments, when the spade portion 1410 is inserted into the bone separation between the first and second bone portions, the pin portion 1420 protruding away from the bone separation is inserted through the positioning block window 1040 such that the underside 1060 of the positioning block 1000 is positioned adjacent to the first and second bone portions. The first bone pin hole 1011 can guide the first bone pin 921 to the first bone portion along a first trajectory defined by the orientation of the pin portion 1420 relative to the positioning block window 1040, and the second bone pin hole 1012 can guide the second bone pin 922 to the second bone portion along a second trajectory defined by the orientation of the pin portion 1420 relative to the positioning block window 1040. However, in other embodiments, when the spade portion 1410 is inserted into a bone separation between a first bone portion and a second bone portion and the pin portion 1420 protruding away from the bone separation is inserted through one or more guide holes 970 formed through one or more insertion guides 950 positioned within the central opening 940 (see, for example, Figures 9A-10), the first pin hole 901 can guide the first bone pin 921 into the first bone portion along a first trajectory defined by the orientation of the pin portion 1420 of the spade guide 1400 relative to the one or more guide holes 970, and the parallel pin hole 911 can guide the second bone pin 922 into the second bone portion along a second trajectory defined by the orientation of the pin portion 1420 of the spade guide 1400 relative to the one or more guide holes 970.

[0293] In some embodiments, the alignment block 1000 may then be removed from the first and second bone pins secured / fixed to the first and second bone portions, the spade guide 1400 may be removed from the bone separation / articulation, and the distraction block 1100 may be placed over the first and second bone pins to move the first and second bone portions 401, 402 away from each other. In some embodiments, the further the distraction block 1100 is slid under the first and second bone pins toward the bone separation / articulation, the more disruption may be achieved.

[0294] In some embodiments, while the bone separation / joint is held in the desired distraction position, the bone surfaces on both sides of the bone separation / joint can be accessed and prepared for fixation / fusion (e.g., the bone surfaces on both sides of the bone separation / joint can be scraped, filed, straightened / flattened, cleaned, etc.) After this bone preparation step is complete, the distraction block 1100 can be slid back up and off the first and second bone pins.

[0295] In some embodiments, the compression block 1200 may then be placed over the first and second bone pins to compress the first and second bone portions 401, 402 toward one another. In some embodiments, the further the compression block 1200 is slid under the first and second bone pins toward the bone separation / articulation, the more compression may be achieved.

[0296] In some embodiments, a locking feature (see, e.g., locking feature 930) can be utilized to hold the compression block 1200 in place on the first and second bone pins to maintain the desired compressed position.

[0297] In some embodiments, the desired compression position may be maintained while subsequent steps of the surgical procedure are performed (e.g., fixation steps including, but not limited to, drilling, tapping, inserting an implant through a window in the guide block, etc.). For example, FIG. 13 shows a guide tool 1300 positioned within the compression block window 1240 of the compression block 1200 to guide a drilling tool, tapping tool, and / or insertion tool, etc. (not shown) with respect to the bone separation / articulation. The guide tool 1300 may be utilized to prepare the bone separation to receive any of the implants / fasteners described or contemplated herein.

[0298] In some embodiments, the guide tool 1300 can be configured to guide a tapping tool (not shown) to form a tapped bone screw at the bone separation / junction.

[0299] In some embodiments, the bone separation / joint can be tapped using a tapping tool (not shown) that has a full helical thread height to form a fully tapped bone screw in the bone separation / joint.

[0300] In some embodiments, the bone separation / junction can be tapped with a tapping tool (not shown) having a partial helical thread height to form a partially tapped bone screw in a first step, and the fastener / implant can include a self-tapping feature or a partial self-tapping feature that can cut the remaining portion of the helical thread height at the bone separation / junction, thereby allowing the fastener / implant to be secured to virgin cut bone. In some embodiments, the fastener / implant can include a self-tapping feature that can cut the entire helical thread height at the bone separation / junction, thereby obviating the need for a tapping tool.

[0301] In some embodiments, the guide tool 1300 may include a first offset drill guide 1310 and a second offset drill guide 1320. The first offset drill guide 1310 may be configured to guide a drill tool (not shown) to form a first pilot hole in a first bone portion for receiving a first leg of a bone staple (see, e.g., FIG. 6A), and the second offset drill guide 1320 may be configured to guide a drill tool to form a second pilot hole in a second bone portion for receiving a second leg of the bone staple. Additionally, the central bore 1330 of the guide tool 1300 may be utilized to guide a drill tool (with or without an additional sleeve that may be disposed within the central bore 1330) to form a pilot hole in the bone separation for receiving any fastener / implant disclosed or contemplated herein (see, e.g., fastener 300 shown in FIG. 6A, FIG. 4, etc.).

[0302] 22-24 show various components for one or more bone separation instrument systems according to other embodiments of the present disclosure. Specifically, FIG. 22 is a perspective top view of an alignment block 2000, FIG. 23 is a perspective top view of a distraction block 2100, and FIG. 24 is a perspective top view of a compression block 2200, according to an embodiment of the present disclosure.

[0303] The alignment block 2000, the distraction block 2100, and / or the compression block 2200 may also be referred to herein as blocks, guide blocks, or implant insertion blocks.

[0304] The positioning block 2000, distraction block 2100, and compression block 1200 may be configured to assist in the preparation and fusion of one or more bone splits that may be formed between one or more bone portions during a surgical procedure by utilizing each block in combination with one or more bone pins (e.g., first bone pin 921, second bone pin 922, third bone pin 933, etc.) to place the first bone pin 921, second bone pin 922, third bone pin 933, etc., on one or more bone portions proximate the one or more bone splits, distract the one or more bone splits during surface preparation, and then compress the one or more bone splits (and / or hold the one or more bone splits under compression) to place one or more suitable implants (e.g., any of the implants described or contemplated herein) in / around the one or more bone splits to stabilize / fix / fuse the one or more bone splits via one or more implants, similar to other procedures already described herein.

[0305] In some embodiments, the alignment block 2000 may include a first bone pin hole 2011, a second bone pin hole 2012, a third bone pin hole 2013, alignment block holes or alignment block windows 2040, an upper surface 2050, a lower surface (not shown), a first lower introduction feature (not shown), a second lower introduction feature (not shown), a third lower introduction feature (not shown), a first upper introduction feature 2051, a second upper introduction feature 2052, and a third upper introduction feature 2053.

[0306] In some embodiments, the distraction block 2100 may include a first bone pin hole 2111, a second bone pin hole 2112, a third bone pin hole 2113, a distraction block hole or distraction block window 2140, an upper surface 2150, a lower surface (not shown), a first lower introduction feature (not shown), a second lower introduction feature (not shown), a third lower introduction feature (not shown), a first upper introduction feature 2151, a second upper introduction feature 2152, and a third upper introduction feature 2153.

[0307] In some embodiments, the compression block 2200 may include a first bone pin hole 2211, a second bone pin hole 2212, a third bone pin hole 2213, compression block holes or compression block windows 2240, an upper surface 2250, a lower surface (not shown), a first lower lead-in feature (not shown), a second lower lead-in feature (not shown), a third lower lead-in feature (not shown), a first upper lead-in feature 2251, a second upper lead-in feature 2252, and a third upper lead-in feature 2253.

[0308] However, it will be understood that in other embodiments, the alignment block 2000, the distraction block 2100, and / or the compression block 2200 may be further modified to include three or more bone pin holes (e.g., four bone pin holes, five bone pin holes, etc.) to receive three or more bone pins to assist in the preparation and fusion / stabilization of one or more bone separations formed between one or more bone portions, as in other surgical procedures described herein.

[0309] In some embodiments, the compression block window 2240 and one or more of the first bone pin hole 2211, the second bone pin hole 2212, and the third bone pin hole 2213 may be joined together, as shown in Figure 24. However, it will also be understood that the windows of any guide block disclosed or contemplated herein may be of any shape, size, configuration, etc. Additionally, the windows of any guide block disclosed or contemplated herein may be bounded completely or partially by one or more side walls of the guide block.

[0310] In some embodiments, each of the alignment block 2000, the extension block 2100, and the compression block 2200 may (or may not) include a locking feature (not shown), as previously described herein with respect to Figures 9A-10. Additionally, it will be understood that the alignment block 2000, the distraction block 2100, and / or the compression block 2200 may (or may not) include any other feature (or functionality) of any guide block disclosed or contemplated herein.

[0311] 15A-15D show various views of a fastener, implant, intervertebral fastener / implant, or bone implant 1500 according to one embodiment of the present disclosure. Specifically, FIG. 15A is a perspective view of the bone implant 1500, FIG. 15B is another perspective view of the bone implant 1500, FIG. 15C is a side view of the bone implant 1500, and FIG. 15D is a cross-sectional side view of the bone implant 1500 taken along line BB of FIG. 15C.

[0312] The bone implant 1500 may generally include a shaft 1505 having a proximal end 1501, a distal end 1502, a longitudinal axis 1503, at least one helical thread 1510 disposed about the shaft 1505, and a torque connection interface 1506 formed in / on the proximal end 1501 of the shaft 1505.

[0313] In some embodiments, the distal end 1502 of the shaft 1505 may be configured with a pointed or sharp tip.

[0314] In some embodiments, the shaft 1505 can include a central longitudinal passage or cannula configured to receive a pin or K-wire (not shown) therethrough.

[0315] In some embodiments, the shaft 1505 can include one or more bars, holes, lattices, passageways 1508, etc. configured to receive bone cement, bone graft material, bone augmentation material, etc. therein. The passageways 1508 can be open on either side of the bone implant 1500 to allow bone to grow through the shaft 1505 transversely to the axis of the shaft 1505 and between the bone on either side of the bone implant 1500.

[0316] In some embodiments, the bone implant 1500 can be configured to be combined with additional spinal fixation devices (not shown), such as pedicle screws, rods, spikes, hooks, spacers, etc., to form one or more spinal fixation systems.

[0317] In some embodiments, the shaft 1505 and / or the at least one helical thread 1510 may include one or more cutting flutes or self-tapping features 1507.

[0318] In some embodiments, the shaft 1505 can have a minor diameter 1521 generally defined by the shape of the shaft 1505 and a major diameter 1581 generally defined by the shape of at least one helical thread 1510 disposed on the shaft 1505.

[0319] In some embodiments, at least one of the minor diameter 1521 and the major diameter 1581 can be constant along at least a portion of the shaft 1505.

[0320] In some embodiments, at least one of the minor diameter 1521 and the major diameter 1581 can vary along at least a portion of the shaft 1505.

[0321] In some embodiments, the minor axis 1521 defined by the shape of the shaft 1505 may be generally constant from the proximal end 1501 of the shaft 1505 to the distal end 1502 of the shaft 1505 .

[0322] In some embodiments, the minor axis 1521 defined by the shape of the shaft 1505 may be configured in a cylindrical shape.

[0323] In some embodiments, at least a portion of the shaft 1505 may be comprised of at least one of a cylindrical shape, a conical shape, a rectangular shape, straight sides, angled sides, conical sides, etc., or any combination thereof.

[0324] In some embodiments, the major axis 1581 defined by the shape of the at least one helical thread 1510 disposed on the shaft 1505 may form a cylindrical shape.

[0325] In some embodiments, the major axis 1581 defined by the shape of the at least one helical thread 1510 disposed on the shaft 1505 may generally decrease from the proximal end 1501 of the shaft 1505 toward the distal end 1502 of the shaft 1505.

[0326] In some embodiments, the ratio of major diameter 1581 to minor diameter 1521 may be less than 1.50.

[0327] In some embodiments, the ratio of major diameter 1581 to minor diameter 1521 may be less than 1.25.

[0328] In some embodiments, the ratio of major axis 1581 to minor axis 1521 may be less than 1.10.

[0329] In some embodiments, the ratio of major axis 1581 to minor axis 1521 may be less than 1.05.

[0330] In some embodiments, the at least one helical thread 1510 can include at least one concave undercut surface 1531 .

[0331] In some embodiments, the at least one concave undercut surface 1531 may be angled toward one of the proximal end 1501 and the distal end 1502 of the shaft 1505.

[0332] However, it will be understood that the bone implant 1500 may include any thread configuration, feature, or form described or contemplated herein for any fastener / implant to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, the at least one helical thread 1510 may include a standard or reverse thread, a "dual start" thread configuration, a crescent shape, etc.

[0333] In some embodiments, when the intervertebral implant or bone implant 1500 is implanted within an intervertebral space between an upper vertebral body and an inferior vertebral body, the at least one concave undercut surface 1531 may engage the upper vertebral body and the lower vertebral body, and the at least one concave undercut surface 1531 may be shaped to resist at least one force transmitted between the upper vertebral body and the lower vertebral body to stabilize the intervertebral space.

[0334] In some embodiments, when the intervertebral or bone implant 1500 is implanted within the sacroiliac joint between the sacrum and ilium of the pelvis, the at least one concave undercut surface 1531 engages the sacrum and the ilium, and the at least one concave undercut surface 1531 can be shaped to resist at least one force transmitted between the sacrum and the ilium to stabilize the sacroiliac joint.

[0335] In some embodiments, the intervertebral or bone implant 1500 may be implanted into the intervertebral space and / or sacroiliac joint from a posterior direction. However, it will be understood that any of the implants described or contemplated herein may be implanted into any joint or bone from an anterior direction, posterior direction, lateral direction, medial direction, inferior direction, superior direction, etc., and / or any combination of those directions (e.g., posterolateral direction, etc.).

[0336] 16A-16D are various views of a fastener, implant, intervertebral fastener / implant, or bone implant 1600 according to another embodiment of the present disclosure. Specifically, FIG. 16A is a perspective view of the bone implant 1600, FIG. 16B is another perspective view of the bone implant 1600, FIG. 16C is a side view of the bone implant 1600, and FIG. 16D is a cross-sectional side view of the bone implant 1600 taken along line CC of FIG. 16C.

[0337] The bone implant 1600 may generally include a tapered shaft 1605 having a proximal end 1601, a distal end 1602, a longitudinal axis 1603, at least one tapered helical thread 1610 disposed about the tapered shaft 1605, and a torque connection interface 1606 formed in / on the proximal end 1601 of the tapered shaft 1605.

[0338] In some embodiments, the distal end 1602 of the tapered shaft 1605 may define a pointed or sharp tip.

[0339] In some embodiments, the tapered shaft 1605 can include a central longitudinal passage or cannula configured to receive a pin or K-wire (not shown) therethrough.

[0340] In some embodiments, the tapered shaft 1605 may include one or more bars, holes, lattices, passageways 1608, etc. configured to receive bone cement, bone graft material, bone reinforcement material, etc. therein.

[0341] In some embodiments, the bone implant 1600 can be configured to be combined with additional spinal fixation devices (not shown), such as pedicle screws, rods, spikes, hooks, spacers, etc., to form one or more spinal fixation systems.

[0342] In some embodiments, the tapered shaft 1605 and / or the at least one tapered helical thread 1610 may include one or more cutting flutes or self-tapping features 1607.

[0343] In some embodiments, the tapered shaft 1605 can have a continuously variable minor or short diameter 1621 generally defined by the shape of the tapered shaft 1605, and a continuously variable major or long diameter 1681 generally defined by the shape of at least one tapered helical thread 1610 disposed about the tapered shaft 1605.

[0344] In some embodiments, at least one of the minor diameter 1621 and the major diameter 1681 can vary along at least a portion of the tapered shaft 1605.

[0345] In some embodiments, at least one of the minor diameter 1621 and the major diameter 1681 can be constant along at least a portion of the tapered shaft 1605.

[0346] In some embodiments, the minor diameter 1621 defined by the shape of the tapered shaft 1605 may generally decrease from the proximal end 1601 of the tapered shaft 1605 to the distal end 1602 of the tapered shaft 1605.

[0347] In some embodiments, the minor axis 1621 defined by the shape of the tapered shaft 1605 may at least partially define a conical shape.

[0348] In some embodiments, at least a portion of the tapered shaft 1605 may be comprised of at least one of a conical shape, a cylindrical shape, a rectangular shape, straight sides, angled sides, conical sides, etc., or any combination thereof.

[0349] In some embodiments, the major axis 1681 defined by the shape of the at least one tapered helical thread 1610 disposed on the tapered shaft 1605 may at least partially define a conical shape.

[0350] In some embodiments, the major axis 1681 defined by the shape of at least one tapered helical thread 1610 arranged on the tapered shaft 1605 may generally decrease from the proximal end 1601 of the tapered shaft 1605 toward the distal end 1602 of the tapered shaft 1605.

[0351] In some embodiments, the ratio of major diameter 1681 to minor diameter 1621 may be less than 1.50.

[0352] In some embodiments, the ratio of major diameter 1681 to minor diameter 1621 may be less than 1.25.

[0353] In some embodiments, the ratio of major diameter 1681 to minor diameter 1621 may be less than 1.10.

[0354] In some embodiments, the ratio of major diameter 1681 to minor diameter 1621 may be less than 1.05.

[0355] In some embodiments, the at least one tapered helical thread 1610 may include at least one concave undercut surface 1631 .

[0356] In some embodiments, the at least one concave undercut surface 1631 may be angled toward one of the proximal end 1601 and the distal end 1602 of the tapered shaft 1605.

[0357] However, it will be understood that the bone implant 1600 may include any thread configuration, feature, or form described or contemplated herein for any fastener / implant to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, the at least one tapered helical thread 1610 may include a standard or reverse thread, a "dual start" thread configuration, a crescent shape, etc.

[0358] In some embodiments, when the intervertebral implant or bone implant 1600 is implanted within an intervertebral space between upper and lower vertebral bodies, the at least one concave undercut surface 1631 may engage the upper and lower vertebral bodies, and the at least one concave undercut surface 1631 may be shaped to resist at least one force transmitted between the upper and lower vertebral bodies to stabilize the intervertebral space.

[0359] In some embodiments, when the intervertebral implant or bone implant 1600 is implanted within the sacroiliac joint between the sacrum and ilium of the pelvis, the at least one concave undercut surface 1631 engages the sacrum and the ilium, and the at least one concave undercut surface 1631 can be shaped to resist at least one force transmitted between the sacrum and the ilium to stabilize the sacroiliac joint.

[0360] In some embodiments, the intervertebral or bone implant 1600 can be implanted into the intervertebral space and / or sacroiliac joint from a posterior direction. However, it will be understood that any of the implants described or contemplated herein can be implanted into any joint or bone from an anterior direction, posterior direction, lateral direction, medial direction, inferior direction, superior direction, etc., and / or any combination of those directions (e.g., posterior-lateral direction, etc.).

[0361] 17-21 illustrate a procedure for implanting an intervertebral implant into an intervertebral space 1730 between an upper vertebral body 1710 and an inferior vertebral body 1720. Specifically, FIG. 17 illustrates a vertebral column 1700 prior to a procedure, and FIG. 18 illustrates the vertebral column 1700 of FIG. 17 with at least a portion of the intervertebral disc 1740 removed and at least one tapped bone screw 1750 formed in at least one of the upper vertebral body 1710 and the inferior vertebral body 1720. FIG. 19 illustrates the vertebral column 1700 of FIG. 18 with the intervertebral fastener or bone implant 1500 of FIG. 15A positioned adjacent the prepared intervertebral space 1730 prior to insertion. FIG. 20 illustrates the vertebral column 1700 of FIG. 19 with a bone implant 1500 inserted into the prepared intervertebral space 1730; and FIG. 21 illustrates the vertebral column 1700 of FIG. 20 with a second intervertebral fastener or bone implant 1500 inserted into the prepared intervertebral space 1730 adjacent to the first intervertebral fastener or bone implant 1500.

[0362] In some embodiments, a surgical procedure or method for implanting an intervertebral implant (such as, for example, bone implant 1500 of FIG. 15A, or bone implant 1600 of FIG. 16A) into an intervertebral space 1730 between an upper vertebral body 1710 and an inferior vertebral body 1720 may include: positioning a distal end of a shaft of the intervertebral implant adjacent to the intervertebral space 1730, engaging a concave undercut surface of a helical thread disposed on the shaft of the intervertebral implant with the upper vertebral body 1710 and the lower vertebral body 1720, and rotating the intervertebral implant in a first rotational direction (e.g., into the intervertebral space 1730 between the upper vertebral body 1710 and the lower vertebral body 1720, as shown in FIG. 15). Rotating the intervertebral implant in the first rotational direction (e.g., clockwise or counterclockwise) to insert the intervertebral implant into the intervertebral space 1730.

[0363] In some embodiments of the method, when the intervertebral implant is implanted within the intervertebral space 1730, the concave undercut surface can be shaped to resist at least one force transmitted between the upper vertebral body 1710 and the lower vertebral body 1720 to stabilize the intervertebral space 1730.

[0364] In some embodiments, the method may also include preparing the intervertebral space 1730 to receive the intervertebral implant. Preparing the intervertebral space 1730 may include at least one of removing at least a portion of the intervertebral disc 1740 intermediate the upper vertebral body 1710 and the lower vertebral body 1720, moving the upper vertebral body 1710 and the lower vertebral body 1720 away from each other, compressing the upper vertebral body 1710 and the lower vertebral body 1720 toward each other, drilling, reaming, broaching, etc., the upper vertebral body 1710 and / or the lower vertebral body 1720.

[0365] In some embodiments, the method may also include forming or pre-tapping at least one tapped bone screw 1750 into at least one of the superior vertebral endplate of the superior vertebral body 1710 and the inferior vertebral endplate of the inferior vertebral body 1720.

[0366] In some embodiments, the intervertebral implant can include a self-tapping feature, and the method may or may not omit the step of forming or pre-tapping at least one tapped bone screw 1750 into at least one of the upper vertebral endplate of the upper vertebral body 1710 and the lower vertebral endplate of the lower vertebral body 1720.

[0367] In some embodiments of the method, additional instruments (not shown) may be utilized to prepare the disc space and endplates and / or to hold the vertebral bodies in a fixed position during distraction, compression, implant insertion, etc.

[0368] In some embodiments of the method, the intervertebral implant may be a first intervertebral implant, and the method may also include implanting a second intervertebral implant in the intervertebral space 1730 adjacent to the first intervertebral implant.

[0369] In some embodiments of the method, at least one of a minor diameter of the shaft and a major diameter of the helical thread of the intervertebral implant may be constant along at least a portion of the shaft.

[0370] In some embodiments of the method, at least one of a minor diameter of the shaft and a major diameter of the helical thread of the intervertebral implant may vary along at least a portion of the shaft.

[0371] However, it will be understood that the intervertebral implant may include (or may include) any shape, thread configuration, feature, configuration, etc. described or contemplated herein for any fastener / implant.

[0372] In some embodiments, the intervertebral implant can include any size, length, diameter, shape, etc. to fit within a given intervertebral space 1730.

[0373] In some embodiments, the intervertebral implant can include any angle (eg, a conical shape, etc.) to provide a desired spinal curvature for the patient.

[0374] In some embodiments, the intervertebral implant can be inserted into the intervertebral space 1730 from a posterior direction, an anterior direction, a lateral direction, or any combination thereof.

[0375] Any procedure / method disclosed herein comprises one or more steps or actions for carrying out the described method. The steps and / or actions of the method may be interchanged with one another. In other words, the order and / or use of certain steps and / or actions may be modified unless a specific order of steps or actions is required for proper operation of an embodiment.

[0376] Any of the fasteners described herein may be configured to be removed and replaced during revision surgery by simply unscrewing and removing the fastener from the bone / tissue in which it resides. Additionally, the fasteners described herein may advantageously be removed from the bone without removing significant amounts of bone during the removal process to preserve the bone. In this manner, the fasteners may be mechanically integrated with the bone while not being cemented to the bone or integrated through bone grafting to provide an immediate and removable connection between the fastener and the bone. Thus, revision surgery utilizing the fasteners described herein may result in less trauma to the bone and improved patient outcomes.

[0377] References throughout this specification to an "embodiment" or "embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, references or variations thereof incorporated throughout this specification do not necessarily all refer to the same embodiment.

[0378] Similarly, in the description of the above embodiments, it will be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that any embodiment requires more features than are expressly recited in that embodiment. Rather, inventive aspects lie in the combination of fewer than all features of a single foregoing disclosed embodiment.

[0379] The term "first" described with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements described in mean-plus-function format are intended to be interpreted in accordance with 35 U.S.C. §112(f). It will be apparent to those skilled in the art that changes can be made to the details of the above-described embodiments without departing from the underlying principles described herein.

[0380] The terms "connected," "coupled," "engaged," and "in communication" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may not be in direct contact with one another and still be functionally coupled. The term "coupled" can include components that are coupled to one another via integral formation, as well as components that are detachably and / or irremovably coupled to one another. The term "in approximate contact" refers to articles that may be in direct physical contact with one another, although the articles may not necessarily be attached together. The phrase "in fluid communication" refers to two or more features that are linked such that fluid in one feature can pass into another feature. Additionally, as defined herein, the term "substantially" means within ±20% of a target value, measurement, or desired property.

[0381] While specific embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the scope of the disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes and variations that will be apparent to those skilled in the art may be made in the arrangement, operation and details of the devices, systems, apparatus and methods disclosed herein.

Claims

1. A bone separation fastener, comprising: A fastener shaft, a proximal end; a distal end; and a fastener shaft having a longitudinal axis; a helical thread disposed about the fastener shaft along the longitudinal axis and having a concave undercut surface; A bone staple, comprising: a first end having a first bone engaging feature; a second end having a second bone engaging feature; an intermediate portion extending between the first end and the second end and including an opening configured to receive the fastener shaft; When the bone separation fastener is implanted along the separation between the first bone portion and the second bone portion, the concave undercut surface is oriented toward one of the proximal end and the distal end of the fastener shaft; the concave undercut surface is configured to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the separation; the first bone-engaging feature engages the first bone portion to connect the first end of the bone staple to the first bone portion; the second bone-engaging feature engages the second bone portion to connect the second end of the bone staple to the second bone portion; The bone separation fastener, wherein the bone staple coupled to the first and second bone portions resists at least one force transmitted between the first and second bone portions to stabilize the separation.

2. The bone separation fastener of claim 1 , wherein a proximal end of the fastener shaft comprises a fastener head.

3. 3. The bone separation fastener of claim 2, wherein when the bone separation fastener is implanted along the separation between the first bone portion and the second bone portion, the fastener head engages with an intermediate portion of the bone staple to couple the fastener shaft to the bone staple.

4. the fastener head includes a first locking feature; The bone separating fastener of claim 3 , wherein the intermediate portion includes a second locking feature configured to engage a first locking feature to lock the fastener head to the bone staple.

5. At least one of the first bone-engaging feature and the second bone-engaging feature: one or more rough surfaces; One or more teeth, one or more blades; one or more ribs, one or more legs, The bone separation fastener of claim 1 , comprising at least one of:

6. the first bone-engaging feature comprises a first leg extending in a first downward direction from a first end of the bone staple; 6. The bone separation fastener of claim 5, wherein the second bone engaging feature comprises a second leg projecting from the second end of the bone staple along a second inferior direction, the first inferior direction being substantially parallel to the second inferior direction.

7. the first bone engaging feature comprises a plurality of first legs projecting downwardly from the first end of the bone staple; The bone separation fastener of claim 5 , wherein the second bone engaging feature comprises a plurality of second legs projecting downwardly from the second end of the bone staple.

8. A bone separation fastener, comprising:

1. A compressible fastener shaft, comprising: a proximal end; a distal end; and a compressible fastener shaft having a longitudinal axis; a helical thread disposed about the compressible fastener shaft along a longitudinal axis, the helical thread having a concave undercut surface; a compression system configured to move the compressible fastener shaft from a first uncompressed state to a second compressed state; When the bone separation fastener is implanted along the separation between the first bone portion and the second bone portion, the concave undercut surface is oriented toward one of a proximal end and a distal end of the compressible fastener shaft; the compression system moves the compressible fastener shaft from a first uncompressed state to a second compressed state; The bone separation fastener, wherein the concave undercut surface compresses the first bone portion toward the second bone portion and resists at least one force transmitted between the first and second bone portions to stabilize the separation.

9. The compression system comprises: an inner bore formed in the compressible fastener shaft; at least one collet feature formed in the compressible fastener shaft about the bore; a compression member configured to move the at least one collet feature radially toward a longitudinal axis of the compressible fastener shaft to move the compressible fastener shaft from a first uncompressed state to a second compressed state; The bone separation fastener of claim 8 comprising:

10. the compression member is removably coupleable to the compressible fastener shaft; 10. The bone separation fastener of claim 9, wherein the compression member engages a distal end of the compressible fastener shaft to radially move the at least one collet feature and compress the compressible fastener shaft.

11. a distal end of the compressible fastener shaft comprising a first chamfered surface; the compression member includes a second chamfered surface; The bone separation fastener of claim 10 , wherein the second chamfered surface engages the first chamfered surface to radially move the at least one collet feature and compress the compressible fastener shaft.

12. The bone separation fastener of claim 9 , wherein the at least one collet feature comprises one or more slots formed in the compressible fastener shaft.

13. The bone separation fastener of claim 9 further comprising a fastener head disposed at a proximal end of the compressible fastener shaft.

14. 14. The bone separation fastener of claim 13, wherein the fastener head comprises a concave shape configured to engage and longitudinally compress the first and second bone portions.

15. the inner bore of the compressible fastener shaft is internally threaded; The compression member a compression member head; a compression member shaft configured to be received within the bore; The compression member shaft a proximal end; a distal end; and an external thread disposed about the distal end of the compression member shaft; When the compression member shaft is received within the bore of the compressible fastener shaft, the external threads of the compression member shaft engage the internal threads of the compressible fastener shaft; 15. The bone separation fastener of claim 14, wherein the compression member head radially compresses the compressible fastener shaft to resist at least one force transmitted between the first bone portion and the second bone portion and stabilize the separation.

16. A bone separation fastener, comprising: A first shaft, a proximal end; a distal end; and a first shaft having a longitudinal axis; a first helical thread disposed about the first shaft along the longitudinal axis and including a first concave undercut surface; 1. A bone plate comprising: a first end having a first opening configured to receive a first shaft into a first bone portion; a second end of the bone plate including a bone engaging feature configured to couple the second end to a second bone portion; a bone plate including an intermediate portion extending between a first end and a second end of the bone plate; Equipped with A bone separation fastener, wherein when the first shaft is implanted across the separation between the first bone portion and the second bone portion, the first shaft passes through the first opening in the bone plate, through the first bone portion and into the second bone portion to stabilize the separation between the first bone portion and the second bone portion.

17. the bone engaging feature: one or more roughened surfaces; One or more teeth; one or more blades; one or more ribs; one or more legs; 17. The bone separation fastener of claim 16, comprising at least one of:

18. A second shaft, a proximal end; a distal end; and a second shaft having a longitudinal axis; a second helical thread disposed about the second shaft along the longitudinal axis and including a second concave undercut surface; 17. The bone separation fastener of claim 16, comprising:

19. 20. The bone separation fastener of claim 18, wherein a second end of the bone plate includes a second opening configured to receive the second shaft.

20. When the second shaft is implanted across the separation between the first and second bone portions, 20. The bone separation fastener of claim 19, wherein the second shaft passes through a second opening in the bone plate, through a second bone portion, and into the first bone portion to stabilize the separation between the first and second bone portions.

21. 1. An intervertebral implant comprising: A shaft, a proximal end; a distal end; and a longitudinal axis; a shaft having a minor diameter; a helical thread disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft; The helical thread is a concave undercut surface angled toward one of the proximal and distal ends of the shaft; a major axis; When the intervertebral implant is implanted into the intervertebral space between the upper and lower vertebral bodies, The ratio of the major axis to the minor axis is less than 1.50; The concave undercut surface engages the superior and inferior vertebral bodies; An intervertebral implant, wherein the concave undercut surface is shaped to resist at least one force transmitted between the superior and inferior vertebral bodies, thereby stabilizing the intervertebral space.

22. 22. The intervertebral implant of claim 21, wherein at least one of the minor and major dimensions is constant along at least a portion of the shaft.

23. The intervertebral implant of claim 21 , wherein the shaft comprises a cylindrical shape.

24. 22. The intervertebral implant of claim 21, wherein the ratio of the major axis to the minor axis is less than 1.

25.

25. 22. The intervertebral implant of claim 21, wherein the ratio of the major axis to the minor axis is less than 1.

10.

26. 22. The intervertebral implant of claim 21, wherein the ratio of the major axis to the minor axis is less than 1.

05.

27. 22. The intervertebral implant of claim 21, wherein the shaft comprises one or more passageways opening on opposite sides of the shaft adjacent the superior and inferior vertebral bodies and configured to receive bone reinforcing material therein.

28. 1. An intervertebral implant comprising: A tapered shaft, a proximal end; a distal end; and a longitudinal axis; a tapered shaft having a minor diameter; a tapered helical thread disposed about the tapered shaft along a longitudinal axis between the proximal and distal ends of the tapered shaft; The tapered helical thread is a concave undercut surface angled toward one of the proximal and distal ends of the tapered shaft; a major axis; When the intervertebral implant is implanted into the intervertebral space between the upper and lower vertebral bodies, The concave undercut surface engages the superior and inferior vertebral bodies; An intervertebral implant, wherein the concave undercut surface is shaped to resist at least one force transmitted between the superior and inferior vertebral bodies, thereby stabilizing the intervertebral space.

29. 30. The intervertebral implant of claim 28, wherein at least one of the minor diameter and the major diameter varies along at least a portion of the tapered shaft.

30. 30. The intervertebral implant of claim 28, wherein the tapered shaft comprises an at least partially conical shape.

31. 30. The intervertebral implant of claim 28, wherein at least a portion of the minor diameter decreases from the proximal end of the tapered shaft toward the distal end of the tapered shaft.

32. 30. The intervertebral implant of claim 28, wherein at least a portion of the major dimension decreases from the proximal end of the tapered shaft toward the distal end of the tapered shaft.

33. 29. The intervertebral implant of claim 28, wherein the tapered shaft comprises one or more passages opening on opposite sides of the tapered shaft adjacent the superior and inferior vertebral bodies and configured to receive bone reinforcing material therein.

34. 30. The intervertebral implant of claim 28, wherein the intervertebral implant comprises one or more self-tapping features.

35. 1. A method of implanting an intervertebral implant into an intervertebral space between superior and inferior vertebral bodies, comprising: positioning a distal end of a shaft of an intervertebral implant adjacent to the intervertebral space; engaging concave undercut surfaces of a helical thread disposed about the shaft with the superior and inferior vertebral bodies; and rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant into the intervertebral space. The method, wherein when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface is shaped to resist at least one force transmitted between the superior and inferior vertebral bodies, stabilizing the intervertebral space.

36. preparing the intervertebral space for receiving the intervertebral implant; The step of preparing the disc space includes: removing at least a portion of the disc between the superior and inferior vertebral bodies; moving the superior and inferior vertebral bodies away from each other; compressing the superior and inferior vertebral bodies toward each other; 36. The method of claim 35, further comprising:

37. an upper vertebral endplate of the superior vertebral body; the inferior vertebral endplate of the inferior vertebral body; 36. The method of claim 35, further comprising forming at least one tapped bone screw in at least one of the bones.

38. The intervertebral implant comprises a first intervertebral implant; 36. The method of claim 35, further comprising implanting a second intervertebral implant in the intervertebral space adjacent to the first intervertebral implant.

39. 36. The method of claim 35, wherein at least one of a minor diameter of the shaft and a major diameter of the helical thread is constant along at least a portion of the shaft.

40. 36. The method of claim 35, wherein at least one of a minor diameter of the shaft and a major diameter of the helical thread varies along at least a portion of the shaft.

41. 1. A bone separation instrument system comprising: A first bone pin, a first proximal end; a first bone pin having a first distal end configured to be secured to a first bone portion; a second bone pin, a second proximal end; and a second distal end configured to be secured to a second bone portion; a second bone pin, the second bone portion being positioned adjacent to the first bone portion, forming a bone separation between the first bone portion and the second bone portion; A guide block, a first bone pin hole configured to receive a first bone pin; a second bone pin hole configured to receive a second bone pin; a window formed through the guide block intermediate the first bone pin hole and the second bone pin hole; When a first bone pin is secured to a first bone portion and inserted through a first bone pin hole, and a second bone pin is secured to a second bone portion and inserted through a second bone pin hole, the first bone pin hole applies a first force to the first bone pin along a first direction to compress or distract the first bone portion relative to the second bone portion; the second bone pin hole applies a second force to the second bone pin along a second direction to compress or distract the second bone portion relative to the first bone portion; a bone separation instrument system, wherein the window is configured to provide access for an implant positioned through the window to couple to at least one of the first bone portion and the second bone portion while the bone separation is compressed or distracted to stabilize the bone separation.

42. The guide block is a first lower lead-in feature formed around the first bone pin hole on the lower surface of the guide block; a second lower lead-in feature formed around the second bone pin hole on the lower surface of the guide block; a first upper lead-in feature formed around the first bone pin hole on the upper surface of the guide block; a second upper lead-in feature formed around the second bone pin hole on the upper surface of the guide block; 42. The bone separation instrument system of claim 41, comprising at least one of:

43. 43. The bone separation instrument system of claim 42, wherein a first longitudinal axis of said first bone pin hole is parallel to a second longitudinal axis of said second bone pin hole.

44. When a first bone pin is secured to a first bone portion and inserted into a first bone pin hole, and a second bone pin is secured to a second bone portion and inserted into a second bone pin hole, 44. The bone separation instrument system of claim 43, wherein the first bone pin hole and the second bone pin hole are separated from one another by a first distance to compress the first bone portion and the second bone portion toward one another.

45. When a first bone pin is secured to a first bone portion and inserted through a first bone pin hole, and a second bone pin is secured to a second bone portion and inserted through a second bone pin hole, 44. The bone separation instrument system of claim 43, wherein the first and second bone pin holes are separated from one another by a second distance to space the first and second bone portions apart.

46. When a first bone pin is secured to a first bone portion and inserted through a first bone pin hole, and a second bone pin is secured to a second bone portion and inserted through a second bone pin hole, 44. The bone separation instrument system of claim 43, wherein the first and second bone pin holes are separated from one another by a third distance to hold the first and second bone portions in a neutral position relative to one another.

47. an insertion guide configured to be at least partially received within the window and including a guide hole formed therethrough; A spade guide, The spade part at the tip of the spade guide, a spade guide including a pin portion at a base end of the spade guide; When the insertion guide is at least partially received within the window, the spade portion is inserted into the bone separation between the first bone portion and the second bone portion, and the pin portion is inserted through the guide hole; the first bone pin hole is configured to guide the first bone pin into the first bone portion along a first trajectory defined by an orientation of the pin portion relative to the guide hole; 44. The bone separation instrument system of claim 43, wherein the second bone pin hole is configured to guide the second bone pin into the second bone portion along a second trajectory defined by an orientation of the pin portion relative to the guide hole.

48. 1. A bone separation instrument system comprising: A first bone pin, a first proximal end; a first bone pin having a first distal end configured to be secured to a first bone portion; a second bone pin, a second proximal end; and a second bone pin including a second distal end configured to be secured to a second bone portion, the second bone portion being positioned adjacent to the first bone portion, such that a bone separation is formed between the first and second bone portions; A spade guide, The spade part at the tip of the spade guide, a spade guide comprising: a pin portion at a proximal end of the spade guide; A placement block, the first bone pin hole is configured to receive a first bone pin; the second bone pin hole is configured to receive a second bone pin; an alignment block hole between the first bone pin hole and the second bone pin hole; When the spade portion of the spade guide is inserted into the bone separation between the first bone portion and the second bone portion and the pin portion of the spade guide is inserted through the alignment block hole, the first bone pin hole is configured to guide the first bone pin into the first bone portion along a first trajectory defined by an orientation of the pin portion relative to the alignment block hole; an alignment block, the second bone pin hole configured to guide the second bone pin into the second bone portion along a second trajectory defined by an orientation of the pin portion relative to the alignment block hole; 1. An implant insert block comprising: a third bone pin hole; a fourth bone pin hole; a window formed through the implant insertion block intermediate the third and fourth bone pin holes; when a first bone pin is secured to the first bone portion and inserted through the third bone pin hole, and a second bone pin is secured to the second bone portion and inserted through the fourth bone pin hole; an implant insertion block, the window configured to couple with at least one of the first bone portion and the second bone portion and provide access for an implant placed therethrough to stabilize the bone separation; A bone separation instrument system comprising:

49. The placement block is a first lower lead-in feature formed around the first bone pin hole on the lower surface of the alignment block; a second lower lead-in feature formed around the second bone pin hole on the lower surface of the alignment block; a first upper guide feature formed around the first bone pin hole on the upper surface of the alignment block; a second upper lead-in feature formed around the second bone pin hole on the upper surface of the alignment block; 49. The bone separation instrument system of claim 48, comprising at least one of:

50. 50. The bone separation instrument system of claim 49, wherein a first longitudinal axis of said first bone pin hole is parallel to a second longitudinal axis of said second bone pin hole.

51. The spade portion is a first substantially planar surface; and a second substantially planar surface opposite the first substantially planar surface; the first substantially flat surface is configured to engage a first surface of a first bone portion within the bone separation portion; 51. The bone separation instrument system of claim 50, wherein the second substantially flat surface is configured to engage a second surface of a second bone portion within the bone separation to indicate a direction of the bone separation with the pin portion of the spade guide.

52. the implant insertion block a first lower lead-in feature formed around the third bone pin hole on the lower surface of the implant insertion block; a second lower lead-in feature formed around the fourth bone pin hole on the lower surface of the implant insertion block; a first upper lead-in feature formed around the third bone pin hole on the upper surface of the implant insertion block; a second upper lead-in feature formed around the fourth bone pin hole on the upper surface of the implant insertion block; 49. The bone separation instrument system of claim 48, comprising at least one of:

53. 53. The bone separation instrument system of claim 52, wherein said third bone pin hole is parallel to said fourth bone pin hole.

54. When a first bone pin is secured to a first bone portion and inserted through a first bone pin hole, and a second bone pin is secured to a second bone portion and inserted through a second bone pin hole, 54. The bone separation instrument system of claim 53, wherein the first and second bone pin holes are spaced apart a first distance to compress the first and second bone portions toward one another.

55. 1. A method of stabilizing a bone separation between a first bone portion and a second bone portion, comprising: inserting a proximal end of a first bone pin into a first bone pin hole of the guide block and applying a first force to the first bone pin along a first direction to compress or distract the first bone portion relative to the second bone portion; inserting a proximal end of a second bone pin into a second bone pin hole of the guide block and applying a second force to the second bone pin along a second direction to compress or distract the second bone portion relative to the first bone portion; compressing or distracting the bone separation by inserting an implant through a window formed in the guide block during compression or distraction of the bone separation; and coupling an implant to at least one of the first bone portion and the second bone portion while the bone separation is undergoing compression or distraction to stabilize the bone separation with the implant.

56. inserting a spade portion of the spade guide into the bone separation portion; engaging a first surface of a first bone portion with a first substantially flat surface of a spade portion; engaging a second surface of the second bone portion with a second substantially flat surface of the spade portion; 56. The method of claim 55, wherein the pin portion of the spade guide extends away from the bone separation to indicate the orientation of the bone separation relative to the first and second bone portions.

57. inserting a distal end of a first bone pin into a first bone pin hole of a guide block; securing a distal end of a first bone pin to a first bone portion while a pin portion of the spade guide extends through a window formed in the guide block; positioning the first bone pin relative to the direction of bone separation by inserting a distal end of a second bone pin into a second bone pin hole in the guide block; securing a distal end of a second bone pin to a second bone portion while the pin portion of the spade guide extends through a window formed in the guide block; positioning the second bone pin relative to the direction of bone separation by 57. The method of claim 56, further comprising:

58. The guide block comprises a first guide block; Compression of the bone separation area inserting a proximal end of a first bone pin into a first bone pin hole of a first guide block and applying a first force to the first bone pin along a first direction to compress the first bone portion relative to the second bone portion; 56. The method of claim 55, further comprising inserting a proximal end of a second bone pin into a second bone pin hole in the first guide block and applying a second force to the second bone pin along a second direction to compress the second bone portion relative to the first bone portion.

59. The guide block comprises a second guide block; The extension of the bone separation part is inserting a proximal end of a first bone pin into a first bone pin hole of a second guide block and applying a first force to the first bone pin along a first direction to distract the first bone portion relative to the second bone portion; 56. The method of claim 55, further comprising inserting a proximal end of a second bone pin into a second bone pin hole in the second guide block and applying a second force to the second bone pin along a second direction to compress the second bone portion relative to the first bone portion.

60. Compression of the bone separation area rotating the guide block to a first position; and inserting a proximal end of the second bone pin into the convergent pin hole of the guide block to apply a compressive force to the bone separation portion; The extension of the bone separation part is rotating the guide block to a second position; and inserting the proximal end of the second bone pin into the flared bone pin hole of the guide block to apply a distraction force to the bone separation portion.

56. The method of claim 55.

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