Surgical bit with drill and tap portions

Abstract

Disclosed herein are components, systems, and methods to form a threaded opening in hard tissue, such as bone. Specifically, embodiments of a surgical bit are disclosed that include a cutting portion having at least one cutting edge and a tap portion having a tap thread both connected to a shaft elongated along an axis of rotation. The tap thread defines a plurality of uninterrupted loops around the axis of rotation. Also disclosed are methods of forming a threaded opening in hard tissue using the surgical bit.

Description

SURGICAL BIT WITH DRILL AND TAP PORTIONSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This patent application claims priority of U.S. Patent Application No. 63 / 672,975, filed on July 18, 2024, the entire disclosure of which is hereby incorporated by reference herein for all purposes.BACKGROUND

[0002] Many bone fixation procedures attach devices, such as sutures, plates, etc., to bone. And these devices may be attached to bone with fixation devices such as bone screws, anchors, etc. To prepare a bone to receive a fixation device, an opening (e.g., a hole) may be drilled in the bone. The opening may be an unthreaded hole or a threaded hole with threads that correspond to those present on the fixation device to be inserted.

[0003] Some procedures and instruments form threads in the sidewall of the bone while forming the hole. Openings having threads formed in a sidewall of the bone prior to insertion of the fixation device may limit crack formation in the sidewall of the opening thereby improving fixation of the fixation device to the bone. Other procedures and instruments include multiple steps, for example forming an unthreaded hole first and then subsequently forming the threads. For example, a drill bit with one or more cutting edges may be advanced into a bone while rotating to remove a portion of the bone thereby forming an unthreaded hole. The drill bit may be removed from the unthreaded hole and a thread tap may be advanced into the unthreaded hole and rotated about an axis to form threads in the sidewall of the hole.

[0004] The insertion and removal of multiple instruments increases the duration of the procedure, especially as the number of holes being formed increases. This disclosure relates to bone fixation systems and related methods. More particularly, this disclosure relates to surgical bits that form threaded openings in bone. The threaded openings are beneficially formed without withdrawing a drill bit from an unthreaded opening formed in a bone by the drill bit prior to insertion of a tap thread that forms threads in the unthreaded opening.BRIEF SUMMARY

[0005] Some embodiments described herein provide a bone fixation system that attaches one or more devices (e.g., hardware such as a suture anchor or a bone plate) to bone. The devices may be inserted directly into respective openings formed in the bone, or may first be inserted through respective openings in a bone plate or otherhardware and then into the respective openings formed in the bone. The bone fixation system may prepare a bone to receive the one or more devices by forming threaded openings in the bone.

[0006] Some embodiments described herein include components of the bone fixation system, such as a surgical bit that includes a drill portion and a tap portion both connected to a shaft. The drill portion includes at least one cutting edge that removes bone to form an unthreaded opening and the tap portion includes a tap thread that enters the unthreaded opening and forms a thread in a sidewall of the bone. Methods of use of the bone fixation system and surgical bit are also described herein.

[0007] Some embodiments of the surgical bit described herein comprise a tap thread that defines a plurality of uninterrupted loops around an axis of rotation of the surgical bit. The threads of a threaded opening in bone may be formed advantageously by the uninterrupted loops of the tap thread. Interrupted tap threads (e.g., cutting flutes), when used to form threads in hard bone may tap the sidewall of the hard bone and then remove the thread that was just formed due to friction and propagation forces. This may be especially true when the interrupted tap threads form the thread under power (e.g., when a power source drives rotation of a shaft that carries the interrupted tap threads or when a substantial axial force is applied to the shaft along the direction of elongation of the shaft).

[0008] Some embodiments of the surgical bit described herein comprise a cutting edge that removes a portion of a bone to form an unthreaded opening in the bone. The cutting edge may be part of a drill portion in the form of a spade drill comprising opposed planar surfaces each having a width measured across the respective face in a first direction perpendicular to an axis of rotation of the surgical bit. The spade drill further defines a depth measured from one of the opposed planar surfaces to the other of the opposed planar surfaces in a second direction perpendicular to both the axis of rotation and the first direction. The width of the spade drill may be greater than the depth. The spade drill as described may advantageously remove bone to form the opening while increasing the operational lifetime of the cutting edge.

[0009] The use of the bone fixation system and components thereof described herein effectively improves thread formation in bone while improving operational lifetime of the cutting edges of the components.

[0010] According to some embodiments, a surgical bit that forms a threaded opening in hard tissue comprises a shaft elongated along an axis, a tap portion connected to the shaft, and a drill portion connected to the shaft and positioned distally from the tap portion. The tap portion comprises a tap thread that defines a plurality of uninterruptedloops around the axis, and the tap thread tapers distally. The drill portion comprises a tapered cutting edge that tapers distally.

[0011] Some embodiments of the tap thread, the cutting edge, or both taper distally such that a width of the tap thread and / or cutting edge decreases distally. The tapered cutting edge may extend proximally along a concave curvature. The tapered cutting edge may include a tapered portion and a non-tapered portion proximal of the tapered portion. The surgical bit may be constructed such that the shaft, tap portion, and drill portion are monolithic.

[0012] Some embodiments of a surgical bit comprises a shaft elongated along an axis, a drill portion and a tap portion each connected to the shaft, and an intermediate portion positioned proximally of the drill portion and distally of the tap portion. The drill portion comprises a first cutting edge. The tap portion is positioned proximally from the drill portion and comprises a tap thread in the form a plurality of uninterrupted loops around the axis. The intermediate portion comprises cutting edges and tap threads on less than 10 percent of a total length of the intermediate portion. The total length of the intermediate portion is measured parallel to the axis and is greater than 2 mm.

[0013] Some embodiments of a surgical bit comprises a shaft elongated along an axis, a drill portion connected to the shaft, and a tap portion connected to the shaft proximally of the drill portion. The drill portion comprises a first cutting edge and defines a cross- sectional dimension measured through the first cutting edge and the axis along a straight line within a first plane that is normal to the axis. The tap portion comprises a tap thread that forms a plurality of connected and uninterrupted loops around the axis. The tap portion defines a major diameter measured through the tap thread and the axis along a straight line within a second plane that is normal to the axis. The cross-sectional dimension of the drill portion ranges from about 70 percent to about 90 percent of the major diameter of the tap portion.

[0014] Some embodiments of a method of forming a threaded opening in hard tissue comprises rotating about an axis a surgical bit comprising a shaft, a first cutting edge, and a tap thread, the surgical bit elongated along the axis. The method further comprises engaging the first cutting edge with the hard tissue while rotating the shaft and advancing the rotating shaft distally to from an unthreaded opening in the hard tissue. After forming the unthreaded opening, the method comprises advancing the surgical bit distally until the tap thread, in the form of a plurality of uninterrupted loops around the axis, enters the unthreaded opening. The threaded opening is formed by forming threads in the unthreaded opening via engagement of the tap thread with the hard tissue.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0015] In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not necessarily drawn to scale, and some of these elements may be arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not necessarily intended to convey any information regarding the actual shape of the particular elements, and may have been solely selected for ease of recognition in the drawings. The headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0016] Figure 1 is an isometric view of a surgical bit.

[0017] Figure 2 is a top plan view of the surgical bit illustrated in Figure 1.

[0018] Figure 3 is a side elevation view of the surgical bit illustrated in Figure 1.

[0019] Figure 4 is an enlarged top plan view of a distal tip of the surgical bit illustrated in Figure 1.

[0020] Figure 5 is a side elevation view of the distal tip illustrated in Figure 4.

[0021] Figure 6 is a front elevation view of the surgical bit illustrated in Figure 1.

[0022] Figure 7 is a cross-sectional view of the distal tip illustrated in Figure 4, taken along line 7-7.

[0023] Figure 8 is a cross-sectional view of the distal tip illustrated in Figure 4, taken along line 8-8.

[0024] Figure 9 is a side, cross-sectional view of the surgical bit illustrated in Figure 1, in use to form a threaded opening in a bone during a surgical procedure.

[0025] Figure 10 is a side, cross-sectional view of the surgical bit illustrated in Figure 9, in use to form the threaded opening in the bone during another phase of the surgical procedure.

[0026] Figure 11 is a side, cross-sectional view of the surgical bit illustrated in Figure 9, in use to form the threaded opening in the bone during another phase of the surgical procedure.

[0027] Figure 12 is a side, cross-sectional view of the surgical bit illustrated in Figure 9, in use to form the threaded opening in the bone during another phase of the surgical procedure.

[0028] Figure 13 is a side, cross-sectional view of the surgical bit illustrated in Figure 9, in use to form the threaded opening in the bone during another phase of the surgical procedure.

[0029] Figure 14 is a side, cross-sectional view of the surgical bit illustrated in Figure 9, in use to form the threaded opening in the bone during another phase of the surgical procedure.DETAILED DESCRIPTION

[0030] As noted above, conventional bone fixation systems are known and utilized to secure hardware such as plates, fasteners, etc. to bone. Some known systems include separate instruments that form an unthreaded opening in a bone, and then after removal of a first instrument that formed the unthreaded opening, cut threads into a sidewall of the bone (using a second instrument) to form a threaded opening. Embodiments of the surgical bit described herein comprise an elongated shaft with both a drill portion and a tap portion connected thereto. Thus, the embodiments of the surgical bit described herein may advantageously decrease the duration of procedures that include the formation of threaded openings, especially those procedures involving the formation of multiple holes.

[0031] Conventional drill and tap bits include interrupted tap threads (e.g., cutting flutes) that cut threads in the sidewall of the bone to form a threaded opening. The threads of a threaded opening in bone may be formed by the uninterrupted loops of the tap thread. In contrast, the surgical bit described herein comprises a tap thread that defines a plurality of uninterrupted loops around an axis of rotation of the surgical bit. The uninterrupted loops of the tap thread of the surgical bits described herein advantageously form threads in the sidewall of an unthreaded opening in bone. Compared to the interrupted tap threads of conventional drill and tap bits, the uninterrupted loops of the surgical bit described herein reduce the chance of the recently formed thread being removed due to friction and propagation forces. Such forces are common when threads are formed under power (e.g., when a power source drives rotation of the surgical bit or when a substantial axial force is applied to the surgical bit parallel to an axis of rotation of the surgical bit).

[0032] Some conventional drill bits have a circular cross-sectional shape, such as a twist or auger drill bit. In some embodiments, the surgical bit described herein comprises a spade bit drill portion with a wider, flat blade having a reduced thickness. The cutting edge(s) being located on the outer end(s) of the flat blade may advantageously evacuate bone from the opening being formed while providing better control to prevent cutting failure modes such as wear, deformation, cracking, and / or chipping of the cutting edge(s), thereby increasing the operational lifetime of the surgical bit.

[0033] Many surgical procedures (e.g., an rotator cuff repair) involve securing hardware (e.g., bone plates, fasteners, etc.) to hard tissue (e.g., bone). For example, a sutureanchor may be inserted into an opening formed in a bone. One or more sutures secured to the suture anchor may then be manipulated to repair soft tissue or other anatomy in proximity to the suture anchor. The suture anchor may have threads (e.g., external threads) that improve pull-out strength when inserted into an opening formed in the bone with threads (e.g., internal threads) that correspond to (e.g., match) the threads of the suture anchor. Embodiments of the surgical bit described herein may advantageously form the threads in bone more fully and without damage / removal in contrast to threads formed in bone with conventional, interrupted cutting flutes.

[0034] Referring now to the drawings, and specifically to Figures 1 to 8, a surgical bit 120 may be rotatable about an axis of rotation 117 to form an opening (e.g., a threaded hole) in hard tissue (e.g., bone). According to some embodiments, the surgical bit 120 may be connected to a source of rotation, such as a drill (e.g., powered or manual). The surgical bit 120 may be part of a kit that also includes one or more fasteners (e.g., suture anchors) sized to be received in a threaded opening formed by the surgical bit 120. The kit may further include the source of rotation for the surgical bit 120 (e.g., a drill). Additionally, the surgical bit 120 may be manufactured and / or sold by itself, independent of any other components of a bone fixation system (e.g., hardware, fasteners, tools, etc.).

[0035] The surgical bit 120 may comprise a shaft 122 that extends from a distal end 124 to a proximal end 126. As shown, the shaft 122 may be elongated along an axis (e.g., a central axis, which may be the axis of rotation 117). The axis of rotation 117 may be parallel to a longitudinal direction L. The surgical bit 120 may comprise a drill portion 130 connected to (e.g., carried by, releasably coupled to, monolithic with, etc.) the shaft 122. The surgical bit 120 may comprise a tap portion 160 connected to (e.g., carried by, releasably coupled to, monolithic with, etc.) the shaft 122. The drill portion 130 may be positioned distally from the tap portion 160 (e.g., closer to the distal end 124 than the tap portion 160 is from the distal end 124). Relatedly, the tap portion 160 may be positioned proximally from the drill portion 130 (e.g., closer to the proximal end 126 than the drill portion 130 is from the proximal end 126).

[0036] The drill portion 130 may comprise at least one cutting edge (e.g., a first cutting edge 132). The first cutting edge 132 may be shaped and positioned such that when rotating about the axis of rotation 117 and moved into contact with hard tissue, the first cutting edge 132 removes a portion of the hard tissue thereby forming an opening in the hard tissue. As shown, the first cutting edge 132 may be formed at an intersection of a first surface 134 of the drill portion 130 and a second surface 136 of the drill portion 130.

[0037] According to some embodiments, at least a portion of the drill portion 130 may be in the form of a spade drill 140. Thus, the drill portion 130 may comprise opposedplanar surfaces (e.g., the first surface 134 and a third surface 138) each having a width W1 measured across the respective face in a lateral direction A that is perpendicular to the axis of rotation 117 and the longitudinal direction L. The drill portion 130 may further define a depth D1 measured from one of the opposed planar surfaces to the other of the opposed planar surfaces (e.g., from the first surface 134 to the third surface 138) in a transverse direction T that is perpendicular to the axis of rotation 117, the longitudinal direction L, and the lateral direction A. The width W1 of the spade drill 140 of the drill portion 130 may be greater than the depth D1.

[0038] As described above, the spade drill 140 advantageously improves operational lifetime of the first cutting edge 132 removing bone compared to other shapes such as a twist drill. Accordingly, the first cutting edge 132 may be formed at the intersection of a major surface (e.g., a surface with a larger area, such as the first surface 134) of the drill portion 130 and a minor surface (e.g., a surface with a smaller area, such as the second surface 136) of the drill portion 130.

[0039] Some embodiments of the surgical bit 120 may comprise a plurality of cutting edges (e.g., the first cutting edge 132 and a second cutting edge 142). The second cutting edge 142 may be shaped and positioned similarly to the first cutting edge 132 such that when rotating about the axis of rotation 117 and moved into contact with hard tissue, the second cutting edge 142 removes a portion of the hard tissue thereby forming an opening in the hard tissue. As shown, the second cutting edge 142 may be opposite the first cutting edge 132 formed at an intersection of the third surface 138 of the drill portion 130 and a fourth surface 144 of the drill portion 130.

[0040] The drill portion 130 may comprise two pairs of parallel surfaces (e.g., the first and third surfaces 134, 138 and the second and fourth surfaces 136, 144). As shown, the first cutting edge 132 and the second cutting edge 142 may be formed by the intersection of surfaces offset by an angle a ranging from 65 degrees to 90 degrees. In some cases, the angle a may range from 70 degrees to 85 degrees, e.g., from 75 degrees to 80 degrees. In terms of lower limits, the angle a may be greater than 65 degrees, e.g., greater than 70 degrees, greater than 75 degrees, greater than 80 degrees, or greater than 85 degrees. In terms of upper limits, the angle a may be less than 90 degrees, e.g., less than 85 degrees, less than 80 degrees, less than 75 degrees, or less than 70 degrees.

[0041] The first cutting edge 132 and any other cutting edges of the drill portion 130 (e.g., the second cutting edge 142) may be tapered along at least a portion of their length J1 measured parallel to the axis of rotation 117. According to some embodiments, the first tapered cutting edge 132 may taper distally such that the width W1 of the drill portion 130 decreases distally. As shown, a first portion 146 of the drillportion 130 may be tapered (e.g., along a concave curvature / surface 152). A second portion 148 of the drill portion 130 may be positioned proximal of the first portion 146. The second portion 148 may extend proximally away from the first portion 146 along the longitudinal direction L (e.g., such that the second portion 148 lacks a longitudinal taper). Alternatively, the second portion 148 may also be tapered along the longitudinal direction L.

[0042] The drill portion 130 may be tapered such that a radial dimension measured from the first cutting edge 132 to the axis of rotation 117 along a direction perpendicular to the axis of rotation decreases distally. The drill portion 130 may be sized to form an unthreaded opening of a desired size (e.g., that corresponds to a fastener to be inserted into the opening). For example, a maximum cross-sectional dimension of the drill portion 130 measured from the first cutting edge 132, through the axis of rotation 117, to the second cutting edge 142 along the radial direction may range from about 3.5 mm to about 5.0 mm.

[0043] In some cases, the maximum cross-sectional dimension may range from 3.75 mm to 4.75 mm, e.g., from 4.0 mm to 4.5 mm. In terms of lower limits, the maximum cross-sectional dimension of the drill portion 130 may be greater than 3.5 mm, e.g., greater than 3.75 mm, greater than 4.0 mm, or greater than 4.5 mm. In terms of upper limits, the maximum cross-sectional dimension of the drill portion 130 may be less than 5.0 mm, e.g., less than 4.75 mm, less than 4.5 mm, less than 4.0 mm, or less than 3.75 mm.

[0044] The tap portion 160 may comprise a tap thread 162 shaped and positioned such that when the tap thread 162 is moved into contact with hard tissue while the shaft 122 is rotating about the axis of rotation 117 the tap thread 162 forms one or more threads in a sidewall of the hard tissue that defines the opening in the hard tissue. As shown, the tap thread 162 may follow a path comprising a plurality of uninterrupted loops around the axis of rotation 117.

[0045] According to one embodiment, the plurality of uninterrupted loops may be in the form of a helix or a double helix. The tap thread 162, when viewed from the side as shown in Figure 4 may be defined by a series of peaks 164. The series of peaks 164 may be evenly spaced along a length J2 of the tap portion 160 such that adjacent ones of the series of peaks 164 are spaced equidistantly.

[0046] The tap portion 160 may define a maximum cross-sectional dimension measured in a plane normal to the axis of rotation 117 (e.g., a width W2 measured in the lateral direction A). The maximum cross-sectional dimension may be circular in shape (e.g., to correspond in shape to the unthreaded opening formed in the hard tissue by the drill portion 130).

[0047] The tap portion 160 may be tapered along at least a portion of its length J2 as measured parallel to the axis of rotation 117. According to some embodiments, at least a portion of the tap portion 160 may taper distally such that the maximum cross-sectional dimension of the tap portion 160 decreases distally. The maximum cross-sectional dimension of the tap portion 160 may be measured radially through the axis of rotation 117. The tap portion 160 may be sized to form threads in the unthreaded opening formed by the drill portion 130. The tap portion 160 may be sized to form threads with desired characteristics (e.g., depth, pitch, etc.) that correspond to a fastener (e.g., a suture anchor) to be inserted into the threaded opening.

[0048] For example, the maximum cross-sectional dimension of the tap portion 160 at a distal end 166 of the tap thread 162 may range from about 80 percent to about 100 percent of the maximum cross-sectional dimension of the tap portion 160 at a proximal end 168 of the tap portion 160. In some cases, the maximum cross-sectional dimension at the distal end 166 may range from about 85 percent to 95 percent, e.g., from about 88 percent to about 92 percent. In terms of lower limits, the maximum cross-sectional dimension of the distal end 166 of the tap portion 160 may be greater than 80 percent of the maximum cross-sectional dimension of the proximal end 168 of the tap portion 160, e.g., greater than 85 percent, greater than 90 percent, or greater than 95 percent. In terms of upper limits, the maximum cross-sectional dimension of the distal end 166 of the tap portion 160 may be less than 100 percent of the maximum cross-sectional dimension of the proximal end 168 of the tap portion 160 may be less than 95 percent, e.g., less than 90 percent, or less than 85 percent.

[0049] According to some embodiments, the size of the maximum cross-sectional dimension of the tap portion 160 may be sized based on the dimensions of the drill portion 130. For example, the maximum cross-sectional dimension of the drill portion 130 may range from 4.0 mm to 4.5 mm, and the maximum cross-sectional dimension of the tap portion 160 may range from about 5.2 mm at the distal end 166 of the tap portion 160 to about 5.7 mm at the proximal end 168 of the tap portion 160. Some embodiments of the maximum cross-sectional dimension the drill portion 130 may range from about 70 percent to about 90 percent of the maximum cross-sectional dimension of the tap portion 160 of the surgical bit 120.

[0050] The surgical bit 120 may comprise an intermediate portion 180 connected to (e.g., carried by, releasably coupled to, monolithic with, etc.) the shaft 122. The intermediate portion 180 may be positioned proximally of the drill portion 130 and distally of the tap portion 160. The intermediate portion 180 may be substantially devoid of cutting edges (e.g., positioned to remove hard tissue upon rotational contact with the hard tissue) and tap threads (e.g., positioned to form threads in a sidewall of the hardtissue upon rotational contact with the sidewall of the hard tissue) along a length J3 of the intermediate portion 180. For example, the intermediate portion 180 may comprise cutting edges and / or tap threads on less than 10 percent of the length J3 of the intermediate portion 180, as measured parallel to the axis of rotation 117.

[0051] The length J3 may be measured from a proximal end 150 of the drill portion 130 to the distal end 166 of the tap portion 160. For example, the length J3 may range from about 2 mm to about 50 mm. In some cases, the length J3 may range from about 3 mm to about 25 mm, e.g., from about 4 mm to about 10 mm. In terms of lower limits, length J3 may be greater than 2 mm, e.g., greater than 3 mm, greater than 4 mm, or greater than 10 mm. In terms of upper limits, the length J3 may be less than 50 mm, e.g., less than 25 mm, less than 10 mm, less than 5 mm, or less than 4 mm.

[0052] As shown, the intermediate portion 180 may define a maximum cross-sectional dimension that is less than that of either the drill portion 130, the tap portion 160, or both the drill portion 130 and the tap portion 160. Thus, according to some embodiments, the intermediate portion 180 may be separated from (i.e., not in contact with) the sidewall of the hard tissue defining the unthreaded opening formed by the drill portion 130 as the intermediate portion 180 passes through the unthreaded opening.

[0053] As described above, the surgical bit 120 may be coupled / couplable to a rotator / source of rotation (e.g., a drill) that rotates the surgical bit 120 about the axis of rotation 117. Some embodiments of the surgical bit 120 may include one or more collars 190. The collar 190 may be received by the drill to couple the surgical bit 120 to the drill. Additionally, and / or alternatively, the one or more collars 190 may include a stop that limits an insertion depth of the surgical bit 120. The one or more collars 190 may be adjustably positionable along the length of the shaft 122, or may be permanently fixed at desired location(s) along the length of the shaft 122.

[0054] Referring to Figures 9 to 14, a method of forming a threaded opening 200 in hard tissue (e.g., a bone 202) comprises rotating the surgical bit 120 about the axis of rotation 117. Rotating the surgical bit 120 comprises rotating the shaft 122, the first cutting edge 132, and the tap thread 162 about the axis of rotation 117. While rotating the surgical bit 120, the first cutting edge 132 is engaged with the bone 202, as shown in Figure 9.

[0055] According to the method, the surgical bit 120 may be advanced distally into the bone 202, while rotating, to from an unthreaded opening 204 in the bone 202, as shown in Figures 10 and 11. After forming the unthreaded opening 204 (e.g., a first portion of the unthreaded opening 204), the method may include advancing the surgical bit 120 distally until the tap thread 162 enters the unthreaded opening 204 (e.g., the first portion of the unthreaded opening), as shown in Figure 12.

[0056] As shown in Figure 13, the method may include forming threads 206 in the unthreaded opening 204 via engagement of the tap thread 162 with the bone 202 thereby forming the threaded opening 200. The threads 206 may be formed in a portion of the unthreaded opening while the first cutting edge 132 is forming a second portion of the unthreaded opening 204.

[0057] The method may include forming the unthreaded opening 204 in the bone 202 via removal of a portion of the bone 202 through contact with the first cutting edge 132 rotating about the axis of rotation. As shown in Figure 14, the method may comprise moving the surgical bit 120 proximally, first withdrawing the tap thread 162 from the threaded opening 200 and then withdrawing the first cutting edge 132 from the threaded opening 200. The method may comprise coupling the surgical bit 120 to a drill / driver that is actuable to rotate the surgical bit 120 about the axis of rotation 117.

[0058] The method may comprise advancing the intermediate portion 180 of the surgical bit 120 into the unthreaded opening 204, as shown in Figure 11. The method may further comprising engaging the second cutting edge 142 of the surgical bit 120 with the bone 202 (e.g., simultaneously with the first cutting edge 132 engaging the bone 202). The method may comprise increasing a depth of the threads 206 via engagement of the tap thread 162 (e.g., due to a cross-sectional dimension of the tap thread 162 that increases distally). Some embodiments of the method may include forming the unthreaded opening 204 with a diameter ranging from about 4.0 mm to about 4.5 mm, and forming the threads 206 with a major diameter ranging from about 5.2 mm to about 5.7 mm. The method may include maintaining a rotational speed of the surgical bit 120 about the axis of rotation 117 while the unthreaded opening 204 is formed and while the threads 206 are formed.

[0059] The above description of illustrated embodiments, including what is described in the Abstract, is not intended to be exhaustive or to limit the embodiments to the precise forms disclosed. Although specific embodiments of and examples are described herein for illustrative purposes, various equivalent modifications can be made without departing from the spirit and scope of the disclosure, as will be recognized by those skilled in the relevant art. The various embodiments described above can be combined to provide further embodiments.

[0060] Many of the methods described herein can be performed with variations. For example, many of the methods may include additional acts, omit some acts, and / or perform acts in a different order than as illustrated or described.

[0061] As used herein, “greater than” and “less than” limits may also include the number associated therewith. Stated another way, “greater than” and “less than” may be interpreted as “greater than or equal to” and “less than or equal to.” It is contemplatedthat this language may be subsequently modified in the claims to include “or equal to.” For example, “greater than 2 mm” may be interpreted as, and subsequently modified in the claims as “greater than or equal to 2 mm.”

[0062] In some embodiments, any or some of the components or steps disclosed herein may be considered optional. In some cases, the disclosed embodiments may expressly exclude any or some of the aforementioned elements or steps in this description, e.g., via claim language. For example, claim language may be modified to recite that the disclosed surgical bit and / or methods, etc., do not utilize or comprise a second cutting edge, an intermediate portion, or a collar. Such negative limitations are contemplated, and this text serves as support for negative limitations for components, steps, and / or features.

[0063] These and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.

Claims

CLAIMS1. A surgical bit that forms a threaded opening in hard tissue, the surgical bit comprising: a shaft elongated along an axis; a tap portion connected to the shaft and comprising a tap thread that defines a plurality of uninterrupted loops around the axis, wherein the tap thread tapers distally; and a drill portion connected to the shaft and positioned distally from the tap portion, and comprising a first tapered cutting edge that tapers distally.

2. The surgical bit of claim 1 wherein the tap thread tapers distally such that a width of the tap thread measured from the tap thread to the axis along a direction perpendicular to the axis decreases distally.

3. The surgical bit of any one of claims 1 and 2 wherein the first tapered cutting edge tapers distally such that a width of the drill portion measured from the first tapered cutting edge to the axis along a direction perpendicular to the axis decreases distally.

4. The surgical bit of any one of claims 1 to 3 wherein the first tapered cutting edge extends proximally along a concave curvature.

5. The surgical bit of any one of claims 1 to 4 wherein the first tapered cutting edge comprises a first portion and a second portion proximal of the first portion, the first portion is tapered, and the second portion extends proximally along a direction parallel to the axis.

6. The surgical bit of any one of claims 1 to 5 wherein the shaft, tap portion, and drill portion are monolithic.

7. The surgical bit of any one of claims 1 to 6 wherein the plurality of uninterrupted loops form a helix.

8. The surgical bit of any one of claims 1 to 7 wherein the drill portion further comprises a second tapered cutting edge positioned opposite the first tapered cutting edge with respect to the axis.

9. The surgical bit of claim 8 wherein the second tapered cutting edge is tapered such that a distance from the second tapered cutting edge to the axis increases as the second tapered cutting edge extends proximally.

10. The surgical bit of claim 9 wherein the second tapered cutting edge extends proximally along a concave curvature while the distance from the second tapered cutting edge to the axis increases.

11. The surgical bit of any one of claims 9 and 10 wherein the second tapered cutting edge comprises a first portion that is tapered and a second portion proximal to the first portion that extends proximally along a direction parallel to the axis.

12. The surgical bit of any one of claims 1 to 11 , further comprising an intermediate portion connected to the shaft and positioned proximally of the drill portion and distally of the tap portion, the intermediate portion comprising cutting edges and tap threads on less than 10 percent of a total length of the intermediate portion, as measured parallel to the axis.

13. The surgical bit of claim 12 wherein the total length of the intermediate portion is between 2 mm and 50 mm.

14. The surgical bit of any one of claims 12 and 13 wherein the total length is measured from a proximal end of the drill portion to a distal end of the tap portion.

15. The surgical bit of any one of claims 1 to 14 wherein the drill portion defines a cross-sectional dimension measured through the first tapered cutting edge and the axis along a straight line within a first plane that is normal to the axis, the tap portion defines a major diameter measured through the tap thread and the axis along a straight line within a second plane that is normal to the axis, and the cross-sectional dimension of the drill portion ranges from about 70 percent to about 90 percent of the major diameter of the tap portion.

16. The surgical bit of claim 15 wherein the cross-sectional dimension ranges from about 4.0 mm to about 4.5 mm, and the major diameter ranges from about 5.2 mm to about 5.7 mm.

17. A surgical bit that forms a threaded opening in hard tissue, the surgical bit comprising: a shaft elongated along an axis; a drill portion connected to the shaft and comprising a first cutting edge; a tap portion connected to the shaft and positioned proximally from the drill portion and comprising a tap thread forming a plurality of uninterrupted loops around the axis; and an intermediate portion connected to the shaft and positioned proximally of the drill portion and distally of the tap portion, the intermediate portion comprising cutting edges and tap threads on less than 10 percent of a total length of the intermediate portion, wherein the total length of the intermediate portion as measured parallel to the axis is greater than 2 mm.

18. The surgical bit of claim 17 wherein the tap thread tapers distally such that a width of the tap thread measured from the tap thread to the axis along a direction perpendicular to the axis decreases distally.

19. The surgical bit of any one of claims 17 and 18 wherein at least a portion of the first cutting edge tapers distally such that a width of the drill portion measured from the first cutting edge to the axis along a direction perpendicular to the axis decreases distally.

20. The surgical bit of any one of claims 17 to 19 wherein the first cutting edge extends proximally along a concave curvature.

21. The surgical bit of any one of claims 17 to 20 wherein the first cutting edge comprises a first portion and a second portion proximal of the first portion, the first portion is tapered, and the second portion extends proximally along a direction parallel to the axis.

22. The surgical bit of any one of claims 17 to 21 wherein the shaft, tap portion, and drill portion are monolithic.

23. The surgical bit of any one of claims 17 to 22 wherein the plurality of uninterrupted loops form a helix.

24. The surgical bit of any one of claims 17 to 23, the drill further comprises a second cutting edge positioned opposite the first cutting edge with respect to the axis, wherein the second cutting edge tapers distally.

25. The surgical bit of claim 24 wherein the second cutting edge extends proximally along a concave curvature while a distance from the second cutting edge to the axis increases, a first portion of the second cutting edge is tapered, and a second portion of the second cutting edge is proximal to the first portion and extends proximally away from the first portion along a direction parallel to the axis.

26. The surgical bit of any one of claims 17 to 25 wherein the drill portion defines a first cross-sectional dimension measured through the first cutting edge and the axis along a straight line within a first plane that is normal to the axis, the intermediate portion defines a second cross-sectional dimension measured through the axis along a straight line within a second plane that is normal to the axis, and the second cross- sectional dimension is less than the first cross-sectional dimension.

27. The surgical bit of claim 26 wherein the tap portion defines a major diameter measured through the tap thread and the axis along a straight line within a second plane that is normal to the axis, and the first cross-sectional dimension of the drill portion ranges from about 70 percent to about 90 percent of the major diameter of the tap portion.

28. The surgical bit of any one of claims 26 and 27 wherein the total length of the intermediate portion ranges from about 80 percent to about 100 percent of the first cross-sectional dimension.

29. The surgical bit of any one of claims 27 and 28 wherein the first cross- sectional dimension ranges from about 4.0 mm to about 4.5 mm, and the major diameter ranges from about 5.2 mm to about 5.7 mm.

30. The surgical bit of any one of claims 17 to 29 wherein the total length of the intermediate portion is between 4 mm and 20 mm.

31. A surgical bit that forms a threaded opening in hard tissue, the surgical bit comprising: a shaft elongated along an axis; a drill portion connected to the shaft and comprising a first cutting edge, wherein the drill portion defines a cross-sectional dimension measured through the first cutting edge and the axis along a straight line within a first plane that is normal to the axis; and a tap portion carried by the shaft and positioned proximally with respect to the drill portion, the tap portion comprising a tap thread that forms a plurality of connected and uninterrupted loops around the axis, wherein the tap portion defines a major diameter measured through the tap thread and the axis along a straight line within a second plane that is normal to the axis, wherein the cross-sectional dimension of the drill portion ranges from about 70 percent to about 90 percent of the major diameter of the tap portion.

32. The surgical bit of claim 31 wherein the first cutting edge extends proximally along a concave curvature such that the cross-sectional dimension of the drill portion increases proximally.

33. The surgical bit of any one of claims 31 and 32 wherein a first portion of the first cutting edge is tapered and a second portion of the first cutting edge proximal to the first portion extends proximally along a direction parallel to the axis such that the cross-sectional dimension of the drill portion is constant along the second portion.

34. The surgical bit of any one of claims 31 to 33, the drill portion further comprising a second cutting edge positioned opposite the first cutting edge with respect to the axis.

35. The surgical bit of claim 34 wherein the second cutting edge tapers distally.

36. The surgical bit of claim 35 wherein the second cutting edge extends proximally along a concave curvature while a distance of the second cutting edge from the axis increases.

37. The surgical bit of any one of claims 35 to 36 wherein a first portion of the second cutting edge is tapered and a second portion of the second cutting edge proximalthe first portion extends proximally away from the first portion along a direction parallel to the axis.

38. The surgical bit of any one of claims 31 to 37, further comprising an intermediate portion connected to the shaft and positioned proximally of the drill portion and distally of the tap portion, the intermediate portion comprising cutting edges and tap threads on less than 10 percent of a total length of the intermediate portion, being devoid of any cutting edges and any tap threads, wherein the total length is at least 2 mm as measured parallel to the axis.

39. The surgical bit of claim 38 wherein the total length ranges between 4 mm and 50 mm.

40. The surgical bit of any one of claims 31 to 39 wherein the cross-sectional dimension ranges from about 4.0 mm to about 4.5 mm, and the major diameter ranges from about 5.2 mm to about 5.7 mm.

41. A method of forming a threaded opening in hard tissue, the method comprising: rotating about an axis a surgical bit comprising a shaft, a first cutting edge, and a tap thread, the surgical bit elongated along the axis; engaging the first cutting edge with the hard tissue while rotating the shaft; advancing the rotating shaft distally to from an unthreaded opening in the hard tissue; after forming the unthreaded opening, advancing the surgical bit distally until the tap thread enters the unthreaded opening, wherein the tap thread is in the form of a plurality of uninterrupted loops around the axis; forming threads in the unthreaded opening via engagement of the tap thread with the hard tissue thereby forming a threaded opening.

42. The method of claim 41 wherein the rotating shaft is advanced distally while the first cutting edge engages the hard tissue.

43. The method of any one of claims 41 and 42 wherein the unthreaded opening in the hard tissue is formed via removal of a portion of the hard tissue through contact with the first cutting edge.

44. The method of any one of claims 41 to 43 wherein the tap thread is in the form of a helix that completes a plurality of uninterrupted loops around the axis.

45. The method of any one of claims 41 to 44, further comprising moving the surgical bit proximally, first withdrawing the tap thread from the threaded opening and then withdrawing the first cutting edge from the threaded opening.

46. The method of any one of claims 41 to 45, further comprising coupling the surgical bit to a drill that is actuable to rotate the surgical bit when coupled to the drill.

47. The method of any one of claims 41 to 46, further comprising advancing an intermediate portion of the surgical bit into the unthreaded opening, the intermediate portion positioned between the first cutting edge and the tap thread and comprising cutting edges and tap threads on less than 10 percent of a total length of the intermediate portion.

48. The method of any one of claims 41 to 47, further comprising engaging a second cutting edge of the surgical bit with the hard tissue simultaneously with the first cutting edge.

49. The method of any one of claims 41 to 48, further comprising increasing a depth of the threads via engagement of the tap thread, which has a cross-sectional dimension that increases distally, with the hard tissue.

50. The method of any one of claims 41 to 49 wherein forming the unthreaded opening comprises forming an unthreaded opening with a diameter ranging from about 4.0 mm to about 4.5 mm, and forming the threads comprises forming threads with a major diameter ranging from about 5.2 mm to about 5.7 mm.

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