Fastening devices, arthroplasty implants, systems, and methods

Abstract

We provide bone implants that maintain long-term fixation. [Solution] The bone implant may include a shaft and a helical thread arranged around the shaft. The shaft may include a proximal end, a distal end, a proximal shaft portion, and a distal shaft portion. The helical thread may include at least one concave undercut surface and a plurality of pitches, which may include at least one first pitch along the proximal shaft portion and at least one second pitch along the distal shaft portion. The at least one concave undercut surface may be angled toward one of the proximal or distal ends of the shaft, and the at least one first pitch and the at least one second pitch may not be equal to each other.

Description

Technical Field

[0001] The present disclosure relates to fastening devices, arthroplasty implants, systems, and methods. More specifically, the present disclosure relates to fastening devices, arthroplasty implants, compression fasteners, etc. having an improved thread design, and fastening systems / methods that utilize a fastening device having an improved thread design. Part of the present disclosure is made in the context of humerus and glenoid implants for shoulder arthroplasty, but the disclosed principles are equally applicable to arthroplasty implants at other sites.

Background Art

[0002] Surgical procedures involving fasteners implanted within bone and other tissues can loosen over time due to multi-axial forces and off-axis loading scenarios that can be applied to the fasteners during the healing process. Conventional fastener thread designs may not provide sufficient fixation of the fasteners to overcome these multi-axial forces and off-axis loading scenarios. Thus, there is a desire for fasteners and arthroplasty implants with an improved thread design to improve bone fixation and load distribution between the bone / fastener interfaces that experience multi-axial and unloading conditions.

[0003] Arthroplasty is performed to restore the function of a diseased joint. Typically, these procedures involve replacing the unhealthy natural joint surface of the joint with an artificial joint surface. The new artificial joint surface is typically fixed to adjacent bone to maintain long-term stability. However, an arthroplasty device implanted within bone can loosen over time due to multi-axial forces and off-axis loading scenarios that can be applied to the arthroplasty device during the healing process. Arthroplasty devices that utilize conventional thread designs, tapered stems, keels, or other methods may not provide sufficient fixation to overcome these multi-axial forces and off-axis loading scenarios. Thus, there is a desire for an arthroplasty device with an improved thread design to improve bone fixation and load distribution between the bone / implant interfaces that experience multi-axial and unloading conditions.

[0004] In shoulder arthroplasty, a humeral implant is attached to the humerus, and a glenoid implant is attached to the glenoid cavity or scapula. There are two distinct categories of shoulder arthroplasty: anatomical and reverse. In anatomical procedures, the implant design is intended to replicate the natural anatomical structure. The humeral head is replaced with a convex hemispherical surface of similar shape, and the glenoid cavity is replaced with a shallow concave cavity. In reverse procedures, the natural bulbolus is reversed. The humeral head is replaced with a cavity fixed to the humerus, and the glenoid cavity is replaced with a sphere (or glenosphere) fixed to the scapula. [Overview of the project] [Problems that the invention aims to solve]

[0005] Regardless of the type of procedure, the fixation of humeral components to the humerus typically involves implants with a shaft portion that extends within the metaphysis of the humerus and optionally into the diaphysis. The goal of these implants is to preserve as much natural bone as possible, maximize the mechanical stability of the implant, and allow for more physiological loading of the bone to maintain long-term fixation. [Means for solving the problem]

[0006] Part of this disclosure is made in the context of humeral and glenoid implants for shoulder arthroplasty. Other uses may include femoral implants for hip or knee arthroplasty, tibial implants for knee or ankle arthroplasty, and implants for the elbow, wrist, hand, foot, etc. summary The various fastening devices, arthroplasty implants, systems, and methods of this disclosure have been developed in accordance with 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 fastening devices, arthroplasty implants, systems, and methods. In some embodiments, the fastening devices, arthroplasty implants, systems, and methods of this disclosure may provide improved bone fixation and load distribution between bone / fastener interfaces under multiaxial and unloading conditions.

[0007] In some embodiments, a compression fastener may include a shaft and a helical thread arranged around the shaft. The shaft may include a proximal end, a distal end, a proximal shaft portion, and a distal shaft portion. The helical thread may include at least one concave undercut surface and a plurality of pitches, which may include at least one first pitch along the proximal shaft portion and at least one second pitch along the distal shaft portion. The at least one concave undercut surface may be angled toward one of the proximal or distal ends of the shaft. The at least one first pitch and the at least one second pitch do not have to be equal to each other.

[0008] In some embodiments, the shaft may include a smooth shaft portion between the proximal shaft portion and the distal shaft portion.

[0009] In some embodiments, the pitches may include a first discrete pitch along the proximal shaft portion and a second discrete pitch along the distal shaft portion.

[0010] In some embodiments, the first discrete pitch may be smaller than the second discrete pitch.

[0011] In some embodiments, the first discrete pitch may be greater than the second discrete pitch.

[0012] In some embodiments, the multiple pitches may include continuously changing pitches.

[0013] In some embodiments, the continuously changing pitch may decrease in variation from the distal end of the shaft to the proximal end of the shaft.

[0014] In some embodiments, the compression fastener may include a shaft, a first helical thread, and a second helical thread. The shaft may include a proximal end, a distal end, a proximal shaft portion, a distal shaft portion, and a smooth shaft portion between the proximal and distal shaft portions. The first helical thread may be positioned around the proximal shaft portion and may include a first concave undercut surface, a first pitch, and a first height. The second helical thread may be positioned around the distal shaft portion and may include a second concave undercut surface, a second pitch, and a second height. The first and second concave undercut surfaces may be angled toward one of the proximal and distal ends of the shaft, the first pitch and the second pitch may not be equal to each other, and the first height and the second height may not be equal to each other.

[0015] In some embodiments, the first pitch may be smaller than the second pitch.

[0016] In some embodiments, the first pitch may be greater than the second pitch.

[0017] In some embodiments, the first height may be greater than the second height.

[0018] In some embodiments, the first concave undercut surface may include a first inflection point at a first inflection point height, the second concave undercut surface may include a second inflection point at a second inflection point height, and the first inflection point height may be equal to the second inflection point height.

[0019] In some embodiments, the proximal end of the second helical thread can be timed to the distal end of the first helical thread.

[0020] In some embodiments, the bone fastener may include a shaft, a helical thread arranged around the shaft having a concave undercut surface, and one or more cutting flutes formed in the bone fastener. The shaft may include a proximal end, a distal end, a proximal shaft portion, and a distal shaft portion. The concave undercut surface may be angled toward one of the proximal and distal ends of the shaft, and one or more cutting flutes may be shaped to push bone fragments along the shaft in at least one direction as the bone fastener rotates within the bone.

[0021] In some embodiments, one or more cutting flutes may include a first cutting flute formed on the proximal shaft portion and a second cutting flute formed on the distal shaft portion. The first and second cutting flutes may be configured to push bone fragments along the shaft in a proximal to distal direction as the bone fastener rotates within the bone.

[0022] In some embodiments, one or more cutting flutes may include a first cutting flute formed on the proximal shaft portion and a second cutting flute formed on the distal shaft portion. The first and second cutting flutes may be configured to push bone fragments along the shaft from distal to proximal as the bone fastener rotates within the bone.

[0023] In some embodiments, one or more cutting flutes may include a first cutting flute formed on the proximal shaft portion and a second cutting flute formed on the distal shaft portion. The first cutting flute may be configured to push bone fragments along the shaft from proximal to distal as the bone fastener rotates within the bone, and the second cutting flute may be configured to push bone fragments from distal to proximal as the bone fastener rotates within the bone.

[0024] In some embodiments, one or more cutting flutes may include a first cutting flute formed in the proximal shaft portion and a second cutting flute formed in the distal shaft portion. The first cutting flute may be configured to extrude bone fragments in a distal-to-proximal direction along the shaft when the bone fastener is rotated within the bone, and the second cutting flute may be configured to extrude bone fragments in a proximal-to-distal direction when the bone fastener is rotated within the bone.

[0025] In some embodiments, the proximal shaft portion may include one or more proximal reverse cutting flutes.

[0026] In some embodiments, the distal shaft portion may include one or more distal reverse cutting flutes.

[0027] In some embodiments, a method for manufacturing a compression fastener includes the steps of positioning a first cutting tool on the proximal shaft portion of a substantially cylindrical base material, rotating the substantially cylindrical base material, and moving the first cutting tool along the proximal shaft portion to form an open surface of a first helical thread arranged around the proximal shaft portion, the first helical thread having a first pitch and a first height. The method also includes the steps of positioning a first cutting tool on the distal shaft portion of a substantially cylindrical base material, rotating the substantially cylindrical base material, and moving the first cutting tool along the distal shaft portion to form a fourth open surface of a second helical thread arranged around the distal shaft portion, the second helical thread having a second pitch and a second height. The method may further include the steps of positioning a second cutting tool on the proximal shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the second cutting tool along the proximal shaft portion to form a first undercut surface and a second undercut surface of a first helical thread. The method may further include the steps of positioning a second cutting tool on the distal shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the second cutting tool along the distal shaft portion to form a first undercut surface and a second undercut surface of a second helical thread. The method may also include the steps of positioning a third cutting tool on the proximal shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the third cutting tool along the proximal shaft portion to form a third undercut surface of a first helical thread. The method may further include the steps of positioning a third cutting tool on the distal shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the third cutting tool along the distal shaft portion to form a third undercut surface of the second helical thread. In some embodiments of the method, the first pitch of the first helical thread does not have to be equal to the second pitch of the second helical thread, and the first height of the first helical thread does not have to be equal to the second height of the second helical thread.

[0028] In some embodiments, the method may also include rotating a substantially cylindrical substrate and moving a first cutting tool along a proximal shaft portion to form a fifth open surface of a first helical thread.

[0029] In some embodiments, the method may include rotating a substantially cylindrical substrate and moving a first cutting tool along a distal shaft portion to form a fifth open surface of a second helical thread.

[0030] In some embodiments, the method includes disposing a cutting tool at an intermediate shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the cutting tool along the intermediate shaft portion to form a smooth shaft portion of the substantially cylindrical substrate between a first helical thread and a second helical thread.

[0031] In some embodiments, the first undercut surface and the second undercut surface of the first helical thread may include a first concave undercut surface, the first undercut surface and the second undercut surface of the second helical thread may include a second concave undercut surface, the third undercut surface and the fourth open surface of the first helical thread may include a first convex undercut surface, and the third undercut surface and the fourth open surface of the second helical thread may include a second convex undercut surface.

[0032] In some embodiments, the first and second concave undercut surfaces and the first and second convex undercut surfaces may include a crescent shape directed toward one of the proximal end and the distal end of the substantially cylindrical substrate.

[0033] In some embodiments, the first and second concave undercut surfaces and the first and second convex undercut surfaces may include a mountain shape directed toward one of the proximal end and the distal end of the substantially cylindrical substrate.

[0034] In some embodiments, the first concave undercut surface may include a first inflection point at a first inflection point height, the first convex undercut surface may include a second inflection point at a second inflection point height, the second concave undercut surface may include a third inflection point at a third inflection point height, and the second convex undercut surface may include a fourth inflection point at a fourth inflection point height. The first inflection point height may be equal to the third inflection point height, and the second inflection point height may be equal to the fourth inflection point height.

[0035] In some embodiments, the first pitch of the first helical thread may be smaller than the second pitch of the second helical thread.

[0036] In some embodiments, the first pitch of the first helical thread may be greater than the second pitch of the second helical thread.

[0037] In some embodiments, the first height of the first helical thread may be greater than the second height of the second helical thread.

[0038] In some embodiments, the first height of the first helical thread may be less than the second height of the second helical thread.

[0039] In some embodiments, the proximal end of the second helical thread can be timed to the distal end of the first helical thread.

[0040] In some embodiments, the first pitch of the first helical thread may remain constant regardless of the selected thickness of the first helical thread.

[0041] In some embodiments, the second pitch of the second helical thread may remain constant regardless of the selected thickness of the second helical thread.

[0042] In some embodiments, a method for manufacturing a compression fastener may include the steps of forming a first helical thread positioned around a proximal shaft portion of a substantially cylindrical base material, and forming a second helical thread positioned around a distal shaft portion of a substantially cylindrical base material. The first helical thread may include a first inner portion projecting substantially from the cylindrical base material to a first height, and an outer portion extending from the first inner portion, the outer portion projecting substantially from the cylindrical base material to a second height greater than the first height. The second helical thread may include a second inner portion projecting substantially from the cylindrical base material to a third height. The second height of the outer portion may be greater than the third height of the second inner portion, and the third height of the second inner portion may be equal to the first height of the first inner portion.

[0043] In some embodiments of the method, the first inner portion of the first helical thread may include a first shape, and the second inner portion of the second helical thread may include a second shape.

[0044] In some embodiments of the method, the first shape and the second shape may be substantially equivalent to each other.

[0045] In some embodiments of this method, the first and second shapes may include a crescent shape directed toward one of the proximal and distal ends of a substantially cylindrical substrate.

[0046] In some embodiments of this method, the first and second shapes may include a V-shape directed toward either the proximal or distal end of a substantially cylindrical substrate.

[0047] In some embodiments of the method, the first inner portion may include a first inflection point at a first inflection point height and a second inflection point at a second inflection point height. The second inner portion may include a third inflection point at a third inflection point height and a fourth inflection point at a fourth inflection point height. The first inflection point height may be equal to the third inflection point height, and the second inflection point height may be equal to the fourth inflection point height.

[0048] In some embodiments, the bone implant may include a shaft comprising a proximal end, a distal end, a longitudinal axis, a proximal shaft portion, and a distal shaft portion. The proximal shaft portion may include a first root diameter and a first helical thread positioned around the proximal shaft portion and defining a first outer diameter of the proximal shaft portion. The first helical thread may include a first concave undercut surface. The distal shaft portion may include a second root diameter and a second helical thread positioned around the distal shaft portion and defining a second outer diameter of the distal shaft portion. The second helical thread may include a second concave undercut surface. The first and second concave undercut surfaces may be angled toward the distal end of the shaft, the second root diameter of the distal shaft portion may be smaller than the first root diameter of the proximal shaft portion, and the first outer diameter of the distal shaft portion may be smaller than the first outer diameter of the proximal shaft portion.

[0049] In some embodiments, the bone implant may include a flange component at the proximal end of the shaft.

[0050] The flange component may include a surface facing the bone and a surface facing the device.

[0051] In some embodiments, the surface facing the bone may include a convex surface.

[0052] In some embodiments, the surface facing the bone may include a hemispherical surface.

[0053] In some embodiments, the bone implant may include a mounting structure configured to secure an instrument to the proximal end of the shaft.

[0054] In some embodiments, the mounting structure may include a post, and the device may include an articular head having a convex hemispherical articular surface. The articular head may be configured to be detachably coupled to the post.

[0055] In some embodiments, the mounting structure may include a recess, and the device may include an insert having a concave, hemispherical articulating surface. The insert may be configured to be removably coupled to the recess.

[0056] In some embodiments, the bone implant may include a shaft, an articular movement member positioned at the proximal end of the shaft, and a helical thread. The shaft may include a proximal end, a distal end, a longitudinal axis, a root diameter, and a threaded shaft portion. The helical thread may be positioned around the shaft and define the length of the threaded shaft portion. The helical thread may include a concave undercut surface angled toward the distal end of the shaft, and the ratio of the length of the threaded shaft portion to the root diameter of the shaft may be less than 1.50.

[0057] In some embodiments, the ratio of the length of the threaded shaft portion to the root diameter of the shaft may be less than 1.25.

[0058] In some embodiments, the ratio of the length of the threaded shaft portion to the root diameter of the shaft may be less than 1.10.

[0059] In some embodiments, the ratio of the length of the threaded shaft portion to the root diameter of the shaft may be equal to 1.0.

[0060] In some embodiments, the ratio of the length of the threaded shaft portion to the root diameter of the shaft may be less than 1.0.

[0061] In some embodiments, the bone implant may include a flange component at the proximal end of the shaft. The flange component may include a surface facing the bone and a surface facing the instrument.

[0062] In some embodiments, the articulated member may be configured to be detachably coupled to a mounting structure at the proximal end of the shaft.

[0063] In some embodiments, a shoulder joint implant may include a shoulder joint device comprising a shaft, a helical thread, and an articular surface at the proximal end of the shaft. The shaft may include a proximal end, a distal end, and a longitudinal axis. The helical thread may be arranged around the shaft along the longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface. The first and third undercut surfaces may be angled toward one of the proximal and distal ends of the shaft. The second undercut surface and the fourth open surface may be angled toward the other of the proximal and distal ends of the shaft.

[0064] In some embodiments, the shoulder joint device may include a glenoid head prosthesis, and the articular surface may include a convex hemispherical surface.

[0065] In some embodiments, the shoulder joint device may include a humeral head prosthesis, and the articular surface may include a convex hemispherical surface.

[0066] In some embodiments, the shoulder joint device may include a glenoid prosthesis, and the articular surface may include a concave hemispherical surface.

[0067] In some embodiments, the shoulder joint device may include a humeral insertion prosthesis, and the articular surface may include a concave hemispherical surface.

[0068] In some embodiments, the shoulder joint implant may include a flange component at the proximal end of the shaft. The flange component may include a surface facing the bone and a surface facing the device.

[0069] These and other features and advantages of the present disclosure will become more fully apparent from the following description and the appended claims, or can be learned from the practice of the apparatus, systems, and methods described below.

[0070] The exemplary embodiments of this disclosure will become more fully apparent from the following description, in conjunction with the accompanying drawings. Understanding that these drawings only illustrate exemplary embodiments and should not be considered to limit the scope of this disclosure, the exemplary embodiments of this disclosure will be described with further specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawing]

[0071] [Figure 1A] This is a front perspective view of a fastener according to one embodiment of the present disclosure. [Figure 1B] Figure 1A is a rear perspective view of the fastener. [Figure 1C] Figure 1A is a side view of the fastener. [Figure 1D] This is a side cross-sectional view of the fastener shown in Figure 1A, taken along line AA shown in Figure 1C. [Figure 2] This is a partial side cross-sectional view of a fastener with a crescent-shaped screw thread. [Figure 3A] This is a front perspective view of a bone implant according to one embodiment of the present disclosure. [Figure 3B] Figure 3A is a posterior perspective view of the bone implant. [Figure 3C] Figure 3A is a side view of the bone implant. [Figure 3D] This is a lateral cross-sectional view of the bone implant shown in Figure 3A, taken along the BB line shown in Figure 3C. [Figure 4A] This is a front perspective view of a bone implant according to another embodiment of the present disclosure. [Figure 4B] Figure 4A is a posterior perspective view of the bone implant. [Figure 4C] Figure 4A is a side view of the bone implant. [Figure 4D] This is a lateral cross-sectional view of the bone implant shown in Figure 4A, taken along the CC line shown in Figure 4C. [Figure 5A] This is a front perspective view of a bone implant according to another embodiment of the present disclosure. [Figure 5B]Figure 5A is a posterior perspective view of the bone implant. [Figure 5C] Figure 5A is a bottom view of the bone implant. [Figure 5D] Figure 5A is a top view of the bone implant. [Figure 5E] Figure 5A is a side view of the bone implant. [Figure 6A] This is a perspective view of an apparatus according to one embodiment of the present disclosure. [Figure 6B] Figure 6A is a side view of the device. [Figure 7A] This is a bottom perspective view of the device according to another embodiment of the present disclosure. [Figure 7B] Figure 7A is a top perspective view of the device. [Figure 8] This is a front view of a shoulder joint according to one embodiment of the present disclosure. [Figure 9] Figure 8 is a perspective view of the scapula at the shoulder joint. [Figure 10] This figure shows the scapula in Figure 9, which has a prepared glenoid cavity. [Figure 11] Figure 10 is a lateral view of the scapula. [Figure 12] This is a lateral cross-sectional view of the scapula shown in Figure 11, taken along the DD line indicated in Figure 11. [Figure 13] Figure 8 is a perspective view of the humerus at the shoulder joint. [Figure 14] This figure shows the humerus with a prepared humeral head, as shown in Figure 13. [Figure 15] Figure 14 is a lateral view of the humerus. [Figure 16] Figure 15 is a lateral cross-sectional view of the humerus. [Figure 17] Figure 8 is a front view of the shoulder joint, showing the prepared humerus and scapula before the acceptance of one or more shoulder joint implants. [Figure 18] Figure 17 is a front view of the shoulder joint equipped with a reverse shoulder arthroplasty system. [Figure 19] Figure 18 is a lateral cross-sectional view of the shoulder joint. [Figure 20]This is a front perspective view of a reverse shoulder arthroplasty system according to one embodiment of the present disclosure. [Figure 21] This is a front perspective view of an anatomical shoulder arthroplasty system according to one embodiment of the present disclosure. [Figure 22A] A front perspective view of a bone implant according to another embodiment of the present disclosure. [Figure 22B] Figure 22A is a posterior perspective view of a bone implant. [Figure 22C] Figure 22A is a side view of a bone implant. [Figure 22D] This is a lateral cross-sectional view of the bone implant shown in Figure 22A, taken along the EE line shown in Figure 22C. [Figure 23A] This is a side perspective view of a fastener according to another embodiment of the present disclosure. [Figure 23B] This figure shows the kit including the fasteners shown in Figure 23A. [Figure 24A] This is a front perspective view of a fastener according to one embodiment of the present disclosure. [Figure 24B] Figure 24A is a rear perspective view of the fastener. [Figure 24C] Figure 24A is a side view of the fastener. [Figure 24D] This is a side cross-sectional view of the fastener shown in Figure 24A, taken along line BB shown in Figure 24C. [Figure 25A] This is a front perspective view of a fastener according to one embodiment of the present disclosure. [Figure 25B] Figure 25A is a rear perspective view of the fastener. [Figure 25C] Figure 25A is a side view of the fastener. [Figure 25D] This is a side cross-sectional view of the fastener shown in Figure 25A, taken along the CC line shown in Figure 25C. [Figure 26A] This is a front perspective view of a fastener according to one embodiment of the present disclosure. [Figure 26B] Figure 26A is a rear perspective view of the fastener. [Figure 26C] Figure 26A is a side view of the fastener. [Figure 26D]This is a side cross-sectional view of the fastener shown in Figure 26A, taken along the line BB shown in Figure 26C. [Figure 27A] This figure shows a cutting process for forming a helical screw thread having a first height. [Figure 27B] This figure shows a cutting process for forming a helical thread having a second height. [Figure 27C] This figure shows the helical threads of Figures 27A and 27B superimposed on each other. [Figure 27D] Figures 27A and 27B show the helical threads of the spiral screw, which are superimposed on each other and utilize the crescent shape shown in Figure 2. [Modes for carrying out the invention]

[0072] The drawings are intended to illustrate the concepts of this disclosure and should be understood to be not drawn to a specific scale. Furthermore, the drawings illustrate exemplary embodiments and do not constitute a limitation on the scope of this disclosure. Detailed explanation The exemplary embodiments of this disclosure will be best understood by reference to the drawings, and throughout the drawings, similar parts are indicated by the same numbering. It will be readily apparent that the components of this disclosure, described schematically and shown in the drawings, may be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed descriptions of the embodiments of implants, systems, and methods shown in the drawings are not intended to limit the scope of this disclosure and merely represent exemplary embodiments of this disclosure.

[0073] The term “exemplary” is used herein to mean “useful as an example, illustration, or diagram.” No embodiment described herein as “exemplary” should necessarily be construed as preferable or advantageous to other embodiments. Various aspects of the embodiments are shown in the drawings, but unless otherwise indicated, the drawings are not necessarily drawn to a fixed scale.

[0074] Figures 1A–1D show various diagrams of a fastener 100, implantable bone anchor, or bone screw according to one embodiment of the present disclosure. Specifically, Figure 1A is a front perspective view of the fastener 100, Figure 1B is a rear perspective view of the fastener 100, Figure 1C is a side view of the fastener 100, and Figure 1D is a side cross-sectional view of the fastener 100 taken along line AA in Figure 1C.

[0075] Generally, the fastener 100 may include a shaft 105 having a proximal end 101, a distal end 102, and a longitudinal axis 103. The fastener 100 may also include a head 104 positioned at the proximal end 101 of the shaft 105, a torque connection interface 106 (either male or female configuration) formed inside or on the head 104, and a self-tapping structure 107 formed at the distal end 102 of the shaft 105.

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

[0077] In some embodiments, the fastener 100 may include a "dual-start" or "dual-lead" thread configuration comprising 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 on the shaft 105 can define the outer diameter to root diameter of the shaft 105 alone.

[0079] In some embodiments, the outer diameter and / or root diameter of the fastener 100 may be constant or substantially constant along the entire length of the fastener, or along most of the length of the fastener. In these embodiments, a constant root diameter may help avoid damaging narrow / delicate bone (e.g., pedicle) when inserting the fastener into the bone. In some embodiments, a pilot hole may be drilled first in the narrow / delicate bone, and then a fastener having a similar root diameter to the diameter of the pilot hole may be selected to avoid damage when inserting the fastener into the bone, as will be explained in more detail below.

[0080] In some embodiments, the depth of the first helical thread 110 and / or the second helical thread 120 on the shaft 105 may vary along the length of the shaft 105 to define one or more outer diameters of the fastener 100, and / or one or more regions along the fastener 100 may include one or more continuously varying outer diameters.

[0081] In some embodiments, the thickness of the shaft 105 may vary along the length of the shaft 105 to define one or more root diameters of the fastener 100, and / or one or more regions along the fastener 100 may have one or more continuously varying root 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 vary discretely or continuously, becoming larger towards the tip of the fastener and smaller towards the head of the fastener (or vice versa).

[0083] In some embodiments, the outer diameter and / or valley diameter may increase towards the proximal end or head of the fastener to increase bone compression when the fastener is ultimately inserted into the bone / tissue.

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

[0085] In some embodiments, the fastener 100 may include a plurality of helical threads arranged around the shaft 105. However, any fastener disclosed or intended herein may include a single helical thread arranged around the shaft of the fastener. Furthermore, the fastener 100 may comprise a plurality of nested helical threads (not shown) having different lengths. In one non-limiting example, the fastener 100 may include a first helical thread 110 that is longer than a second helical thread 120, so that the fastener 100 comprises a double thread along the first portion of the shaft 105 and a single thread along the second portion of the shaft 105.

[0086] In some embodiments, the multiple helical threads may include three helical threads having a “triple start” or “triple lead” thread structure (not shown).

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

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

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

[0090] In some embodiments, the fastener 100 may include a plurality of threads (e.g., a double helix thread) having any of the shapes disclosed herein, located adjacent to one of the proximal and distal ends of the fastener 100, as well as a single second thread having any of the shapes disclosed herein, located adjacent to the other of the proximal and distal ends of the 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, Figure 1D), the plurality of first concave undercut surfaces 131 and the plurality of second convex undercut surfaces 142 may be directed toward (i.e., toward) the proximal end 101 of the shaft 105.

[0094] In some embodiments, the plurality of first convex undercut surfaces 141 and the plurality of second concave undercut surfaces 132 may be directed toward (i.e., toward) the distal end 102 of the shaft 105.

[0095] In some embodiments, at least one of the plurality of first concave undercut surfaces 131, plurality of first convex undercut surfaces 141, plurality of second concave undercut surfaces 132, and plurality of second convex undercut surfaces 142 may include 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 comprise a plurality of first bend shapes (including at least one surface and / or at least one undercut surface angled with respect to the longitudinal axis 103 of the shaft 105), each comprising a plurality of first intermediate portions 151 directed toward (i.e., toward) the distal end 102 of the shaft 105. This may be referred to as a “standard” thread 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 have a plurality of second bend shapes (including at least one surface angled with respect to the longitudinal axis 103 of the shaft 105, and / or at least one undercut surface) comprising a plurality of second intermediate portions 152 directed (i.e., 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 deform / migrate along the shaft of the fastener between a standard orientation and an opposite orientation.

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

[0100] As shown in Figure 1D, the proximal and distal surfaces of the first helical thread 110 (i.e., the first concave undercut surface 131 and the first convex undercut surface 141 in the fastener 100 in Figure 1D) do not have to be mirror symmetry with respect to any plane perpendicular to the longitudinal axis 103 of the fastener 100. Rather, the first concave undercut surface 131 and the first convex undercut surface 141 may be substantially parallel to each other. The same applies to the second helical thread 120, where the second concave undercut surface 132 and the second convex undercut surface 142 may be substantially parallel to each other, although they do not have to be mirror symmetry with respect to each other.

[0101] Conversely, as shown in Figure 1D, the surface oriented proximal to the first helical thread 110 may have mirror symmetry with respect to the surface oriented distal to 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 with respect to a plane 170 that bisects the space between them and is located perpendicular to the longitudinal axis 103.

[0102] Similarly, the distally oriented surface of the first helical thread 110 may have mirror symmetry with respect to the proximal oriented 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 with respect to a plane 172 that bisects the space between them and is located perpendicular to the longitudinal axis 103.

[0103] This mirror symmetry may exist along most of the lengths of the first and second helical threads 110 and 120, with symmetry across different planes located between adjacent turns of the first and second helical threads 110 and 120 along the length of the longitudinal axis 103. Such mirror symmetry helps to more effectively capture bone between the first and second helical threads 110 and 120, and can also facilitate the manufacture of the fastener 100.

[0104] 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 include at least one partial crescent shape directed toward (i.e., toward) the distal end 102 and / or the proximal end 101 of the shaft 105. Figure 2 shows a partial cross-sectional view of a fastener 200 including a crescent shape as a 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 directed toward (i.e., toward) the distal end 102 of the shaft 105, and the second helical thread 120 may include at least one partial crescent shape directed toward (i.e., 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 directed toward (i.e., toward) the distal end 102 of the shaft 105, and the second helical thread 120 may include a second plurality of partial crescent shapes directed toward (i.e., toward) the proximal end 101 of the shaft 105.

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

[0108] In some embodiments, the first helical thread 110 is bisected by a line 123 shown in Figure 2, and each crescent shape may 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, similar to the helical thread shown in Figure 1D, except that it has a curved surface instead of a flat surface.

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

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

[0111] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may be replaced with inclined surfaces without any undercuts (such as those used in standard sawtooth thread designs) (not shown in Figure 2). Similarly, other thread designs disclosed herein may utilize inclined or sawtooth thread designs on at least one side of the helical thread.

[0112] In some embodiments, fasteners may have only standard threads or only reverse threads. The desired thread type may depend on the type and / or magnitude of the load applied to the fastener. For example, a screw that is loaded axially away from the bone into which it is embedded may have standard threads, while a screw that is loaded axially toward the bone into which it is embedded may have reverse threads. A screw that can experience multiaxial loading and / or unloading conditions may, to improve bone fixation between the bone / fastener interface and load sharing during multiaxial loading and / or unloading conditions, include at least one standard thread and at least one reverse thread, reducing high bone strain applied to the bone and distributing multiaxial forces in a load-sharing configuration rather than a load-bearing configuration. Shear loads and / or bending moments can also be optimally resisted by any selected combination of threads, thread configurations, and / or thread variations, as intended herein, to optimally resist shear loads, bending moments, multi-axis loading and unloading conditions, etc.

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

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

[0115] In some embodiments, the geometric shape of the threads of a fastener (having standard threads and / or reverse threads) may be modified 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 shape of the thread, the dimensions associated with the thread (e.g., length / width / height / inflection point, etc., associated with the thread), the outer diameter, the root diameter, the angle formation / angle associated with any surface of the thread, the "hitting" of the thread (right-hand vs. left-hand thread, etc.), etc., may be modified to suit any particular mounting medium, loading pattern, desired radial load force, pull-out strength, application, procedure, etc., which may be relevant.

[0116] In some embodiments, the material of any part of the fasteners described herein includes, but is not limited to, metals (e.g., titanium, cobalt, stainless steel), metal alloys, plastics, polymers, ceramics, PEEK, UHMWPE, composite materials, added particles, textured surfaces, biological materials, biomaterials, bone, and the like.

[0117] In some embodiments, any of the fasteners described herein may include additional structures such as self-tapping structures, anti-loosening structures (e.g., anti-loosening threads formed on or near the head of the fastener, or on a portion of the fastener), cannulations, any type of fastener head (or no fastener head), or any type of torque connection interface (or no torque connection interface).

[0118] In some embodiments, a tap (not shown) may be used to pre-form threads in the bone according to any thread shape disclosed or intended herein. Thus, a tap having any suitable shape may be used in combination with any fastener described or intended herein to match, or substantially match, the geometric shape of the threads of a given fastener.

[0119] In some embodiments, the root diameter of the fastener may be selected to match, or substantially match, the diameter of the pilot hole formed in the bone, in order to avoid bone damage when the fastener is inserted into the pilot hole.

[0120] Furthermore, or alternatively, the type of screw and / or the geometric shape of the screw may be modified based on the type of bone to which the fastener is to be fixed. For example, fasteners fixed to osteoporotic bone may perform better if standard or reverse screws are used, or if the pitch, outer diameter, and / or root diameter are increased or decreased, or if the angle formation of the screw surface is adjusted.

[0121] In some embodiments, the surgical kit may include multiple fasteners having any of the different fasteners and thread options described or intended herein. The surgeon may select the appropriate fastener from the kit based on the specific load to be applied and / or the quality of the bone to which the fastener is to be fixed.

[0122] Continuing with Figure 1D, in some embodiments, the first helical thread 110 may include a plurality of first undercut faces 111, a plurality of second undercut faces 112, a plurality of third undercut faces 113, and a plurality of fourth open faces 114.

[0123] In some embodiments, the second helical thread 120 may include a plurality of fifth undercut faces 125, a plurality of sixth undercut faces 126, a plurality of seventh undercut faces 127, and a plurality of eighth open faces 128.

[0124] In some embodiments, one or more of the plurality of first undercut surfaces 111, plurality of second undercut surfaces 112, plurality of third undercut surfaces 113, plurality of fourth open surfaces 114, plurality of fifth undercut surfaces 125, plurality of sixth undercut surfaces 126, plurality of seventh undercut surfaces 127, and plurality of eighth open surfaces 128 may include at least one flat or substantially flat surface.

[0125] In some embodiments, the plurality of first undercut surfaces 111, the plurality of third undercut surfaces 113, the plurality of sixth undercut surfaces 126, and the plurality of eighth open surfaces 128 may be angled toward the distal end 102 of the shaft 105.

[0126] 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.

[0127] In some embodiments, when the fastener 100 is viewed in cross-section along a plane intersecting the longitudinal axis 103 of the shaft 105 (as shown in Figure 1D), the first helical thread 110 may include at least one chevron shape directed toward (i.e., toward) the distal end 102 of the shaft 105. Similarly, the second helical thread 120 may also include at least one chevron shape directed toward (i.e., toward) the proximal end 101 of the shaft 105.

[0128] In some embodiments, when the fastener 100 is viewed in cross-section along a plane intersecting the longitudinal axis 103 of the shaft 105 (as shown in Figure 1D), the first helical threads 110 may include a first plurality of chevron shapes directed toward (i.e., toward) the distal end 102 of the shaft 105. Similarly, the second helical threads 120 may include a second plurality of chevron shapes directed toward (i.e., toward) the proximal end 101 of the shaft 105.

[0129] In some embodiments, the first plurality of V-shapes and the second plurality of V-shapes may be arranged alternately and continuously along the shaft 105 of the fastener 100 (see, for example, Figure 1D).

[0130] In some embodiments, a plurality of first coupling spaces 161 and a plurality of second coupling spaces 162 may be formed along the shaft 105 of the fastener 100 between the first helical thread 110 and the second helical thread 120.

[0131] In some embodiments, a plurality of first bonding spaces 161 may be formed between a first concave undercut surface 131 and a second concave undercut surface 132.

[0132] In some embodiments, a plurality of second bonding spaces 162 may be formed between the first convex undercut surface 141 and the second convex undercut surface 142.

[0133] In some embodiments, the multiple first bond spaces 161 may be larger in size than the multiple second bond spaces.

[0134] In some embodiments, the plurality of first bonding spaces 161 and the plurality of second bonding spaces 162 are shaped and / or configured to bond with the bone / other tissues contained therein, thereby reinforcing the fixation of the fastener 100 within the bone / other tissues and providing additional resistance to multiaxial forces that may be applied to the fastener 100 and / or the bone / other tissues.

[0135] In some embodiments, a plurality of second undercut surfaces 112 and a plurality of sixth undercut surfaces 126 may be angled toward each other to increase fixation and resistance to multiaxial forces and to trap bone / other tissue within a plurality of first joint spaces 161.

[0136] In some embodiments, a plurality of third undercut surfaces 113 and a plurality of seventh undercut surfaces 127 may be angled toward each other to increase fixation and resistance to multiaxial forces and to trap bone / other tissue within a plurality of second joint spaces 162.

[0137] In some embodiments, the plurality of first undercut surfaces 111 and the plurality of fifth undercut surfaces 125 may each form an angle α with respect to the longitudinal axis 103 of the shaft 105, as shown in Figure 1D.

[0138] In some embodiments, the angle α may be greater than 90 degrees.

[0139] In some embodiments, the multiple second undercut surfaces 112 and the multiple sixth undercut surfaces 126 may each form an angle β with respect to the longitudinal axis 103 of the shaft 105.

[0140] In some embodiments, the angle β may be less than 90 degrees.

[0141] In some embodiments, the plurality of third undercut surfaces 113 and the plurality of seventh undercut surfaces 127 may each form an angle θ with respect to the longitudinal axis 103 of the shaft 105.

[0142] In some embodiments, the angle θ can be about 90 degrees.

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

[0144] Any fastener described or intended herein may include any thread structure, feature, or form described or intended herein to achieve optimal fixation within a given bone / tissue. Furthermore, any fastener described or intended herein may be used in combination with (or within) any system, method, or apparatus described or intended herein.

[0145] Figures 3A–3D show various diagrams of a fastener, implant, shoulder joint implant, or bone implant 300 according to another embodiment of the present disclosure. Specifically, Figure 3A is a front perspective view of the bone implant 300, Figure 3B is a rear perspective view of the bone implant 300, Figure 3C is a side view of the bone implant 300, and Figure 3D is a side cross-sectional view of the bone implant 300 taken along line BB in Figure 3C.

[0146] The bone implant 300 may generally include a proximal end 301, a distal end 302, a longitudinal axis 303, a proximal shaft portion 308, a distal shaft portion 309, a first helical thread 310, a second helical thread 320, one or more self-tapping structures 307, a flange component 380, a mounting structure or implant post 390, and a shaft 305 having a torque connection interface 306 formed inside / on the implant post 390.

[0147] In some embodiments, the proximal shaft portion 308 may have a first root diameter 321 and a first outer diameter 381 defined by a first helical thread 310.

[0148] In some embodiments, the distal shaft portion 309 may have a second root diameter 322 and a second outer diameter 382 defined by a second helical thread 320.

[0149] In some embodiments, at least a portion of the first valley diameter 321 and / or the second valley diameter 322 may be constant. However, it will also be understood that in some embodiments, at least a portion of the first valley diameter 321 and / or the second valley diameter 322 may not be constant.

[0150] In some embodiments, at least a portion of the first outer diameter 381 and / or the second outer diameter 382 may be constant. However, it will also be understood that in some embodiments, at least a portion of the first outer diameter 381 and / or the second outer diameter 382 may not be constant.

[0151] In some embodiments, the second valley diameter 322 of the distal shaft portion 309 may be smaller than the first valley diameter 321 of the proximal shaft portion 308.

[0152] In some embodiments, the second outer diameter 382 of the distal shaft portion 309 may be smaller than the first outer diameter 381 of the proximal shaft portion 308.

[0153] In some embodiments, the first helical thread 310 may include a first concave undercut surface 331, and the second helical thread 320 may include a second concave undercut surface 332.

[0154] In some embodiments, the first concave undercut surface 331 and the second concave undercut surface 332 may be angled toward the distal end 302 of the shaft 305.

[0155] However, it will also be understood that the bone implant 300 may include any thread structure, features, or configurations described or intended herein with respect to any fastener / implant in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, the first and second helical threads 310, 320 may include standard threads or reverse threads, "dual-start" thread configurations, etc. Furthermore, it will also be understood that the bone implant 300 may be used in conjunction with (or within) any system or procedure described or intended herein.

[0156] In some embodiments, the flange component 380 may be positioned closer to the proximal end of the shaft 305.

[0157] In some embodiments, the flange component 380 may include a surface 386 facing the bone and a surface 384 facing the instrument.

[0158] In some embodiments, the surface 386 facing the bone may include a convex surface.

[0159] In some embodiments, the surface 386 facing the bone may include a partially spherical shape.

[0160] In some embodiments, the surface 384 facing the device may include a flat, circular surface.

[0161] In some embodiments, the flange component 380 may include one or more passages (not shown) that penetrate the flange component 380, similar to the one or more passages 420 shown in Figures 4A-4D.

[0162] In some embodiments, one or more passages may be configured to receive one or more bone screws (not shown) passing through them, and / or to promote inward bone growth within one or more passages during the healing process.

[0163] In some embodiments, a mounting structure (e.g., an implant post 390, or an implant recess 391 shown in Figure 21) may be located on the proximal end 301 of the shaft 305 and may be configured to removably secure the device to the bone implant 300.

[0164] In some embodiments, the implant recess 391 (see Figure 21) may be configured to be removably coupled to an instrument such as an insert 700, as shown in Figures 7A and 7B and described in more detail below.

[0165] In some embodiments, the implant post 390 may be configured to be removably coupled to an instrument such as an articular head 600, as shown in Figures 6A and 6B and described in more detail below.

[0166] In some embodiments, the implant post 390 may protrude proximally from the flange component 380.

[0167] In some embodiments, the implant post 390 may have a cylindrical shape.

[0168] In some embodiments, the implant post 390 may have a tapered cylindrical shape or a partially conical shape.

[0169] In some embodiments, the implant post 390 may have a Morse taper.

[0170] Figures 4A–4D show various diagrams of a fastener, implant, shoulder joint implant, or bone implant 400 according to another embodiment of the present disclosure. Specifically, Figure 4A is a front perspective view of the bone implant 400, Figure 4B is a rear perspective view of the bone implant 400, Figure 4C is a side view of the bone implant 400, and Figure 4D is a side cross-sectional view of the bone implant 400 taken along line CC in Figure 4C.

[0171] The bone implant 400 may generally include a shaft 405 having a proximal end 401, a distal end 402, a longitudinal axis 403, a helical thread 410, one or more self-tapping structures 407, a flange component 480, a mounting structure or implant post 490, and a torque connection interface 406 formed inside / on the implant post 490.

[0172] In some embodiments, the shaft 405 may have a root diameter 421 and an outer diameter 481 defined by a helical thread 410.

[0173] In some embodiments, at least a portion of the valley diameter 421 may be constant. However, it will also be understood that in some embodiments, at least a portion of the valley diameter 421 may not be constant.

[0174] In some embodiments, at least a portion of the outer diameter 481 may be constant. However, it will also be understood that in some embodiments, at least a portion of the outer diameter 481 may not be constant.

[0175] In some embodiments, the helical thread 410 may include a concave undercut surface 431.

[0176] In some embodiments, the concave undercut surface 431 may be angled toward the distal end 402 of the shaft 405.

[0177] However, it will also be understood that the bone implant 400 may include any thread structure, features, or configurations described or intended herein with respect to any fastener / implant in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, the helical thread 410 may have a standard thread or a reverse thread, a "dual-start" thread configuration, and so on. Furthermore, it will also be understood that the bone implant 400 may be used in conjunction with (or within) any system or procedure described or intended herein.

[0178] In some embodiments, the flange component 480 may be positioned closer to the proximal end of the shaft 405.

[0179] In some embodiments, the flange component 480 may include a surface 482 facing the bone and a surface 484 facing the instrument.

[0180] In some embodiments, the surface 482 facing the bone may include a convex surface.

[0181] In some embodiments, the surface 482 facing the bone may include a partially spherical shape.

[0182] In some embodiments, the surface 484 facing the device may include a flat, circular surface.

[0183] In some embodiments, the flange component 480 may include one or more passages 420 formed through it.

[0184] In some embodiments, one or more passages 420 may be configured to receive one or more bone screws (not shown) passing through them, and / or to promote inward growth of bone within one or more passages 420 during the healing process.

[0185] In some embodiments, a mounting configuration (e.g., an implant post 490, or alternatively, an implant recess (not shown) similar to the implant recess 590 shown in Figure 20) may be located on the proximal end 401 of the shaft 405, and a device such as the insert 700 shown in Figures 7A and 7B may be configured to be removably fixed to the bone implant 400.

[0186] In some embodiments, the implant post 490 may be configured to be detachably coupled to an instrument such as the articular head 600 shown in Figures 6A and 6B.

[0187] In some embodiments, the implant post 490 may protrude proximally from the flange component 480.

[0188] In some embodiments, the implant post 490 may have a cylindrical shape.

[0189] In some embodiments, the implant post 490 may have a tapered cylindrical shape or a partially conical shape.

[0190] In some embodiments, the implant post 490 may have a Morse taper.

[0191] Figures 5A–5E show various diagrams of a fastener, implant, shoulder joint implant, or bone implant 500 according to another embodiment of the present disclosure. Specifically, Figure 5A is a front perspective view of the bone implant 500, Figure 5B is a rear perspective view of the bone implant 500, Figure 5C is a bottom view of the bone implant 500, Figure 5D is a top view of the bone implant 500, and Figure 5E is a side view of the bone implant 500.

[0192] The bone implant 500 may generally include a shaft 505 having a proximal end 501, a distal end 502, a longitudinal axis 503, a helical thread 510, one or more self-tapping structures 507, a flange component 580, a mounting structure or implant recess 590, and a central longitudinal passage 520.

[0193] In some embodiments, the shaft 505 may have a root diameter 521 and an outer diameter 581 defined by a helical thread 510.

[0194] In some embodiments, at least a portion of the valley diameter 521 may be constant. However, it will also be understood that in some embodiments, at least a portion of the valley diameter 521 may not be constant.

[0195] In some embodiments, at least a portion of the outer diameter 581 may be constant. However, it will also be understood that in some embodiments, at least a portion of the outer diameter 581 may not be constant.

[0196] In some embodiments, the helical thread 510 may include a concave undercut surface 531.

[0197] In some embodiments, the concave undercut surface 531 may be angled toward the distal end 502 of the shaft 505.

[0198] However, it will also be understood that the bone implant 500 may include any screw structure, features, or configurations described or intended herein with respect to any fastener / implant in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, the helical threads 510 may have standard threads or reverse threads, "dual-start" thread configurations, etc. Furthermore, it will also be understood that the bone implant 500 may be used in conjunction with (or within) any system or procedure described or intended herein.

[0199] In some embodiments, a helical screw 510 positioned around the shaft 505 may define a threaded shaft portion 515 along the length of the shaft 505.

[0200] In some embodiments, the ratio of the length of the threaded shaft portion 515 to the root diameter 521 of the shaft 505 may be less than 1.50.

[0201] In some embodiments, the ratio of the length of the threaded shaft portion 515 to the root diameter 521 of the shaft 505 may be less than 1.25.

[0202] In some embodiments, the ratio of the length of the threaded shaft portion 515 to the root diameter 521 of the shaft 505 may be less than 1.10.

[0203] In some embodiments, the ratio of the length of the threaded shaft portion 515 to the root diameter 521 of the shaft 505 may be equal to 1.0.

[0204] In some embodiments, the ratio of the length of the threaded shaft portion 515 to the root diameter 521 of the shaft 505 may be less than 1.0.

[0205] In some embodiments, the flange component 580 may be positioned closer to the proximal end of the shaft 505.

[0206] In some embodiments, the flange component 580 may include a surface 582 facing the bone and a surface 584 facing the instrument.

[0207] In some embodiments, the surface 582 facing the bone and / or the surface 584 facing the instrument may each have a flat, circular surface. However, it will also be understood that in some embodiments, the surface 582 facing the bone and / or the surface 584 facing the instrument may have a convex surface, a concave surface, a partial sphere, and the like.

[0208] In some embodiments, the flange component 580 may be formed integrally with the shaft 505. However, it will also be understood that the flange component 580 may be coupled to the shaft 505 by any suitable method, including but not limited to Morse tapers, set screws, tabs, locking elements, etc. (not shown), without departing from the spirit or scope of the present disclosure.

[0209] In some embodiments, a mounting structure (for example, an implant recess 590 or an implant post 591 shown in Figure 21) may be located on the proximal end 501 of the shaft 505 and may be configured to removably secure an instrument or joint member to the bone implant 500.

[0210] In some embodiments, the implant recess 590 may be configured to be removably coupled to an articulating member such as the insert 700 shown in Figures 7A and 7B.

[0211] In some embodiments, the implant post 591 may be configured to be removably coupled to an articular member, such as the articular head 600 shown in Figures 6A and 6B.

[0212] In some embodiments, the implant post 591 may protrude proximally from the flange component 580.

[0213] In some embodiments, the implant post 591 may have a cylindrical shape.

[0214] In some embodiments, the implant post 591 may have a tapered cylindrical shape or a partially conical shape.

[0215] In some embodiments, the implant post 591 may have a Morse taper.

[0216] Figures 6A and 6B show a perspective view and a side view of a device, a shoulder joint device, a joint member, or a joint head 600 according to one embodiment of the present disclosure.

[0217] The joint head 600 may generally include a proximal end 601, a distal end 602, a convex articular surface 610, a post recess 620, a flange component recess 630, and an inclined surface 640.

[0218] In some embodiments, the joint head 600 may include a glenoid head prosthesis that can be used in a reverse total shoulder arthroplasty system (see, for example, the joint head 600 shown in Figures 19 and 20).

[0219] In some embodiments, the joint head 600 may include a humeral head prosthesis that can be used in anatomical shoulder arthroplasty (see, for example, the joint head 600 shown in Figure 21).

[0220] In some embodiments, the convex articular surface 610 may include a convex hemispherical articular surface.

[0221] In some embodiments, the convex articular surface 610 of the articular head 600 is received within and / or in contact with the concave articular surface 710 of the insert 700 shown in Figures 7A and 7B, and can perform articular movement.

[0222] In some embodiments, the post recess 620 formed in the joint head 600 may be shaped and configured to be removably coupled to the implant post of a bone implant as described herein.

[0223] In some embodiments, the post recess 620 may have a cylindrical shape.

[0224] In some embodiments, the post recess 620 may include a tapered cylindrical shape or a partially conical shape.

[0225] In some embodiments, the post recess 620 may be provided with a Morse taper.

[0226] In some embodiments, a flange component recess 630 formed at the distal end 602 of the joint head 600 may be shaped and configured to removably connect to a flange component of a bone implant as described herein.

[0227] Figures 7A and 7B show a bottom and top perspective view of a device, shoulder joint device, joint member, or insert 700 according to one embodiment of the present disclosure.

[0228] The insert 700 may generally include a proximal end 701, a distal end 702, a concave articular surface 710, an outer surface 730, an implant-facing surface 782, and an insert post 720.

[0229] In some embodiments, the insert 700 may include a glenoid prosthesis that can be used in a reverse total shoulder arthroplasty system (see, for example, the insert 700 shown in Figures 19 and 20).

[0230] In some embodiments, the insert 700 may include a humeral insertion prosthesis that can be used in anatomical shoulder arthroplasty (see, for example, the insert 700 shown in Figure 21).

[0231] In some embodiments, the concave articular surface 710 may include a concave hemispherical articular surface.

[0232] In some embodiments, the concave articular surface 710 of the insert 700 can receive and / or articulate with the convex articular surface 610 of the articular head 600, as shown in Figures 6A and 6B.

[0233] In some embodiments, the insert post 720 of the insert 700 may be shaped and configured to removably connect to the implant recess of the bone implant as described herein.

[0234] In some embodiments, the insert post 720 may have a cylindrical shape.

[0235] In some embodiments, the insert post 720 may have a tapered cylindrical shape or a partially conical shape.

[0236] In some embodiments, the insert post 720 may be equipped with a Morse taper.

[0237] Figures 8–19 illustrate an exemplary shoulder arthroplasty procedure according to one embodiment of the present disclosure. Specifically, Figure 8 is a front view of the shoulder joint 800 including the scapula 810 and the humerus 850; Figures 9–12 show the preparation of the scapula 810; Figures 13–16 show the preparation of the humerus 850; Figure 17 is a front view of the prepared shoulder joint 800; Figure 18 is a front view of the shoulder joint 800 with a reverse shoulder arthroplasty system; and Figure 19 is a side cross-sectional view of Figure 18.

[0238] Figures 9-12 show the preparation of scapula 810 during an exemplary shoulder arthroplasty procedure. Specifically, Figure 9 is a perspective view of scapula 810 before preparation, Figure 10 shows scapula 9 after glenoid preparation, Figure 11 is a lateral view of the prepared scapula, and Figure 12 is a lateral cross-sectional view of scapula 11 taken along line DD of Figure 11.

[0239] In some embodiments, the glenoid fossa 815 may be prepared by drilling holes in the surface of the glenoid fossa 815 using a suitable reamer tool (not shown) to form a prepared glenoid surface 816.

[0240] In some embodiments, the prepared articular surface 816 may include a substantially flat surface.

[0241] In some embodiments, the prepared articular surface 816 may include a concave surface.

[0242] In some embodiments, the prepared articular surface 816 may include a concave hemispherical surface.

[0243] In some embodiments, the glenoid cavity 815 may be further prepared by forming a glenoid bone tunnel 820 within the scapula 810 using one or more drilling tools (not shown).

[0244] In some embodiments, the glenoid bone tunnel 820 may comprise a proximal bone tunnel portion 821 and a distal bone tunnel portion 822.

[0245] In some embodiments, the diameter of the proximal bone tunnel portion 821 may be sized and shaped to accommodate the first valley diameter 321 of the bone implant 300 (see Figure 3D), and the diameter of the distal bone tunnel portion 822 may be sized and shaped to accommodate the second valley diameter 322 of the bone implant 300.

[0246] In some embodiments, the diameter of the proximal bone tunnel portion 821 may be smaller than the first valley diameter 321 of the bone implant 300, and / or the diameter of the distal bone tunnel portion 822 may be smaller than the second valley diameter 322 of the bone implant 300.

[0247] In some embodiments, the diameter of the proximal bone tunnel portion 821 may be equal to the first valley diameter 321 of the bone implant 300, and / or the diameter of the distal bone tunnel portion 822 may be equal to the second valley diameter 322 of the bone implant 300.

[0248] In some embodiments, the diameter of the proximal bone tunnel portion 821 may be greater than the first valley diameter 321 of the bone implant 300, and / or the diameter of the distal bone tunnel portion 822 may be greater than the second valley diameter 322 of the bone implant 300.

[0249] In some embodiments, the proximal bone tunnel portion 821 may be internally threaded with a first bone tapping tool (not shown) to form a first bone thread 831 around the proximal bone tunnel portion 821.

[0250] In some embodiments, the distal bone tunnel portion 822 can be threaded with a second bone tapping tool (not shown) to form a second bone thread 832 around the distal bone tunnel portion 822.

[0251] It will be understood that the first bone thread 831 and / or the second bone thread 832 can be sized and shaped to receive any screw structure, feature, or configuration described or contemplated herein for optimal fixation within a given bone / tissue with respect to any fastener / implant.

[0252] Figures 13 - 16 illustrate the preparation of the humerus 850 during an exemplary shoulder arthroplasty procedure. Specifically, FIG. 13 is a perspective view of the humerus 850 prior to preparation, FIG. 14 shows the humerus 850 with the prepared humeral head 855, FIG. 15 is a side view of the prepared humerus, and FIG. 16 is a side cross-sectional view of FIG. 15.

[0253] In some embodiments, the humeral head 855 can be prepared by cutting and / or drilling the humeral head 855 using a suitable cutting tool and / or a reamer tool (not shown) to form a prepared humeral head surface 856.

[0254] In some embodiments, the prepared humeral head surface 856 can include a substantially flat surface.

[0255] In some embodiments, the prepared humeral head surface 856 can include a concave surface.

[0256] In some embodiments, the prepared humeral head surface 856 can include a concave hemispherical surface.

[0257] In some embodiments, the humeral head 855 can be further prepared by forming a humeral tunnel 860 within the humeral head 855 using a drilling tool (not shown).

[0258] In some embodiments, the diameter of the humeral tunnel 860 may be sized and shaped to accommodate the valley diameter 521 of the bone implant 500 (see Figure 5E).

[0259] In some embodiments, the diameter of the humeral tunnel 860 may be smaller than the valley diameter 521 of the bone implant 500.

[0260] In some embodiments, the diameter of the humeral tunnel 860 may be equal to the valley diameter 521 of the bone implant 500.

[0261] In some embodiments, the diameter of the humeral tunnel 860 may be greater than the valley diameter 521 of the bone implant 500.

[0262] In some embodiments, the humeral tunnel 860 may be internally threaded with a bone tapping tool (not shown) to form bone threads 861 around the humeral tunnel 860.

[0263] It will be understood that the bone screw 861 may be sized and shaped to accommodate any screw structure, features, or form described or intended herein with respect to any fastener / implant, in order to achieve optimal fixation within a given bone / tissue.

[0264] Figure 17 shows the prepared shoulder joint bone before implant placement. Figure 18 shows the prepared shoulder joint from Figure 17 with the reverse shoulder arthroplasty system from Figure 20 to be placed therein, and Figure 19 shows a lateral section of Figure 18. Alternatively, the anatomical shoulder arthroplasty system shown in Figure 21 may be placed in the prepared shoulder joint from Figure 17.

[0265] As described above, Figures 20 and 21 show frontal perspective views of a reverse shoulder arthroplasty system and an anatomical shoulder arthroplasty system, respectively. The reverse shoulder arthroplasty system shown in Figure 20 can utilize the components shown and described in Figures 3A-3D and 5A-7B, and is installed in the shoulder joint 800 shown in Figure 19. In this way, as the reverse shoulder arthroplasty system of Figure 20, the implant recess 590 of the bone implant 500 can receive the insert post 720 of the insert 700, and the post recess 620 of the joint head 600 can receive the implant post 390 of the bone implant 300.

[0266] Alternatively, the anatomical shoulder arthroplasty system shown in Figure 21 may utilize components that have complementary characteristics to those of the reverse shoulder arthroplasty system shown in Figure 20. For example, in the anatomical shoulder arthroplasty system of Figure 21, the post recess 620 of the joint head 600 may receive the implant post 591 of the bone implant 500, and the implant recess 391 of the bone implant 300 may receive the insert post 720 of the insert 700.

[0267] Figures 22A–22D show various diagrams of a fastener, implant, or bone implant 900 according to another embodiment of the present disclosure. Specifically, Figure 22A is a front perspective view of the bone implant 900, Figure 22B is a rear perspective view of the bone implant 900, Figure 22C is a side view of the bone implant 900, and Figure 22D is a side cross-sectional view of the bone implant 900 taken along line EE in Figure 22C.

[0268] The bone implant 900 may generally include a tapered shaft 905 having a proximal end 901, a distal end 902, a longitudinal axis 903, at least one tapered helical thread 910 arranged around the tapered shaft, and a torque connection interface 906 formed inside / on the proximal end 901 of the tapered shaft 905.

[0269] In some embodiments, the distal end 902 of the tapered shaft 905 may have a pointed or sharp tip.

[0270] In some embodiments, the tapered shaft 905 may have one or more self-tapping structures or machined flutes (not shown).

[0271] In some embodiments, the tapered shaft 905 may have a continuously varying root diameter 921, which is generally defined by the shape of the tapered shaft 905, and a continuously varying outer diameter 981, which is generally defined by the shape of at least one tapered helical thread 910 arranged around the tapered shaft 905.

[0272] In some embodiments, the continuously changing valley diameter 921, defined by the shape of the tapered shaft 905, may include at least a partially conical shape.

[0273] In some embodiments, the continuously changing outer diameter 981, defined by the shape of at least one tapered helical thread 910 arranged around the tapered shaft 905, may include at least a partially conical shape.

[0274] In some embodiments, the continuously changing valley diameter 921, defined by the shape of the tapered shaft 905, can generally decrease in change from the proximal end 901 of the tapered shaft 905 to the distal end 902 of the tapered shaft 905.

[0275] In some embodiments, the continuously changing outer diameter 981, defined by the shape of at least one tapered helical thread 910 arranged around the tapered shaft 905, can generally decrease in change from the proximal end 901 of the tapered shaft 905 to the distal end 902 of the tapered shaft 905.

[0276] In some embodiments, at least one tapered helical thread 910 may include at least one concave undercut surface 931.

[0277] In some embodiments, at least one concave undercut surface 931 may be angled toward one of the proximal end 901 and the distal end 902 of the tapered shaft 905.

[0278] However, it will also be understood that the bone implant 900 may include any screw structure, feature, or configuration described or contemplated herein for any fastener / implant to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, at least one tapered helical thread 910 may comprise a standard thread or a reverse thread, a "dual start" thread configuration, a crescent shape, and the like.

[0279] Furthermore, it will also be understood that the bone implant 900, or a portion of the general design / shape of the bone implant 900, may be utilized in conjunction with (or within) any fastener, bone implant, system, or procedure described and contemplated herein. For example, any of the fasteners / bone implants described or contemplated herein may generally be configured to include a tapered shaft with tapered helical threads disposed around the tapered shaft. As one such non-limiting example, the design of the bone implant 300 shown in FIGS. 3A - 3D may be modified to include a tapered shaft with tapered helical threads disposed around the tapered shaft, instead of, or in addition to, the proximal shaft portion 308 and / or the distal shaft portion 309 described above with reference to FIGS. 3A - 3D, etc.

[0280] Figure 23A shows a fastener, or compression fastener 1300, according to another embodiment of the present disclosure, which will be described in more detail below with respect to Figures 24A–26D. The compression fastener 1300 may be used to repair a fracture by compressing two or more bone fragments together to bring one or more fractures together. The compression fastener 1300 may have any screw structure, features, or form described or intended herein to achieve optimal fixation within a given bone / tissue.

[0281] Figure 23B shows System / Kit 1350, which may include one or more fasteners described or intended herein in various sizes and forms, as well as any suitable support devices to assist in preparing and / or inserting the fasteners into the bone.

[0282] Figures 24A–24D show various illustrations of a compression fastener, bone fastener, or fastener 1400 according to another embodiment of the present disclosure. Specifically, Figure 24A is a front perspective view of fastener 1400, Figure 24B is a rear perspective view of fastener 1400, Figure 24C is a side view of fastener 1400, and Figure 24D is a side cross-sectional view of fastener 1400 taken along line BB in Figure 24C.

[0283] The fastener 1400 may generally include a shaft 1405 having a proximal end 1401, a distal end 1402, a longitudinal axis 1403, a proximal shaft portion 1408, a distal shaft portion 1409, an intermediate shaft portion 1419, a first helical thread 1410, a second helical thread 1420, one or more cut flutes 1407 (and / or reverse cut flutes), a central longitudinal passage 1429 that allows for guided insertion of the fastener 1400 on a K-wire or pin (not shown), and a torque connection interface 1406.

[0284] In some embodiments, the fastener 1400 may have a root diameter 1460 defined by the shaft 1405 of the fastener 1400.

[0285] In some embodiments, at least a portion of the root diameter 1460 may be constant along the shaft 1405 of the fastener 1400.

[0286] In some embodiments, at least a portion of the root diameter 1460 may vary along the shaft 1405 of the fastener 1400.

[0287] In some embodiments, the valley diameters of the distal shaft portion 1409, the intermediate shaft portion 1419, and / or the proximal shaft portion 1408 may be constant and / or substantially equal to each other.

[0288] In some embodiments, at least a portion of the valley diameter 1460 of the distal shaft portion 1409 may be smaller than the valley diameter of the intermediate shaft portion 1419 and / or the proximal shaft portion 1408.

[0289] In some embodiments, the fastener 1400 may have an outer diameter 1465 defined by one or more helical threads arranged around the shaft 1405 of the fastener 1400.

[0290] In some embodiments, as described above, one or more helical threads may be arranged around the shaft 1405 or a portion of the shaft 1405.

[0291] In some embodiments, the fastener 1400 may include a first helical thread 1410 and a second helical thread 1420 separated by a smooth shaft portion or an intermediate shaft portion 1419, as shown in Figures 24A-26D.

[0292] In some embodiments, the fastener 1400 may include a single helical thread (not shown) arranged around the shaft 1405 between the proximal end 1401 and the distal end 1402 of the shaft 1405. In these embodiments, the single helical thread may span the distal shaft portion 1409, the intermediate shaft portion 1419, and the proximal shaft portion 1408. In these embodiments, the intermediate shaft portion 1419 may not be threadless / smooth.

[0293] In some embodiments, the fastener 1400 may include a plurality of helical threads (not shown) arranged around the shaft 1405 between the proximal end 1401 and the distal end 1402 of the shaft 1405. In these embodiments, some or all of the helical threads may span the distal shaft portion 1409, the intermediate shaft portion 1419, and / or the proximal shaft portion 1408. In these embodiments, the intermediate shaft portion 1419 may not be threadless / smooth.

[0294] In some embodiments, at least a portion of the outer diameter 1465 may be constant along one or more helical threads of the fastener 1400.

[0295] In some embodiments, at least a portion of the outer diameter 1465 may vary along one or more helical threads of the fastener 1400.

[0296] In some embodiments, the outer diameters 1465 of one or more helical threads around the distal shaft portion 1409, the intermediate shaft portion 1419, and / or the proximal shaft portion 1408 may be constant and / or substantially equal to one another.

[0297] In some embodiments, the outer diameters 1465 of one or more helical threads around the distal shaft portion 1409, the intermediate shaft portion 1419, and / or the proximal shaft portion 1408 may not be constant to one another and / or may not be substantially equal to one another.

[0298] In some embodiments, the outer diameter 1465 of one or more helical threads around the distal shaft portion 1409, the intermediate shaft portion 1419, and / or the proximal shaft portion 1408 may vary continuously.

[0299] In some embodiments, the outer diameter 1465 of one or more helical threads may increase in a continuously varying manner from the distal end 1402 of the shaft 1405 toward the proximal end 1401 of the shaft 1405.

[0300] In some embodiments, the outer diameter 1465 of one or more helical threads may decrease in a continuously changing manner from the distal end 1402 of the shaft 1405 toward the proximal end 1401 of the shaft 1405.

[0301] In some embodiments, the outer diameter 1465 of one or more helical threads may decrease in a manner that changes continuously from the distal end 1402 of the shaft 1405 toward the intermediate shaft portion 1419, and then increase in a manner that changes continuously from the intermediate shaft portion 1419 toward the proximal end 1401 of the shaft 1405.

[0302] In some embodiments, the outer diameter 1465 of one or more helical threads may increase in a manner that changes continuously from the distal end 1402 of the shaft 1405 toward the intermediate shaft portion 1419, and then decrease in a manner that changes continuously from the intermediate shaft portion 1419 toward the proximal end 1401 of the shaft 1405.

[0303] In some embodiments, the outer diameter 1465 or first height 1481 of the first helical thread 1410, located around the proximal shaft portion 1408, may be equal to the outer diameter 1465 or second height 1482 of the second helical thread 1420, located around the distal shaft portion 1409.

[0304] In some embodiments, the outer diameter 1465 or first height 1481 of the first helical thread 1410, located around the proximal shaft portion 1408, does not have to be equal to the outer diameter 1465 or second height 1482 of the second helical thread 1420, located around the distal shaft portion.

[0305] In some embodiments, the outer diameter 1465 or first height 1481 of the first helical thread 1410, located around the proximal shaft portion 1408, may be greater than the outer diameter 1465 or second height 1482 of the second helical thread 1420, located around the distal shaft portion 1409. This may allow for greater bone engagement by the first helical thread 1410.

[0306] However, it will also be understood that in some embodiments, the outer diameter 1465 or first height 1481 of the first helical thread 1410, which is located around the proximal shaft portion 1408, may be smaller than the outer diameter 1465 or second height 1482 of the second helical thread 1420, which is located around the distal shaft portion 1409.

[0307] In some embodiments, one or more helical threads arranged around the shaft 1405 may include at least one concave undercut surface. The at least one concave undercut surface may be angled toward one of the proximal end 1401 and the distal end 1402 of the shaft 1405.

[0308] In some embodiments, the first helical thread 1410 may include a first concave undercut surface 1431, and the second helical thread 1420 may include a second concave undercut surface 1432. The first and second concave undercut surfaces 1431 and 1432 may be angled toward one of the proximal end 1401 and the distal end 1402 of the shaft 1405.

[0309] However, it will also be understood that the fastener 1400 may include any screw structure, features, size, form, etc., described or intended herein, in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, one or more helical threads may include standard threads or reverse threads (or a combination thereof), "dual-start" thread configurations, crescent shapes, V-shapes, etc.

[0310] In some embodiments, one or more helical threads may include multiple pitches.

[0311] In some embodiments, the multiple pitches may include at least one first pitch along the proximal shaft portion 1408 and at least one second pitch along the distal shaft portion 1409.

[0312] In some embodiments, at least one first pitch and at least one second pitch may not be equal to each other. In this way, the distal helical thread portion having the second pitch may be advanced through the first bone portion into the second bone portion (not shown). Next, as the proximal helical thread portion having the first pitch enters the first bone portion, the continuous rotation of the fastener 1400 will compress the two bone portions toward each other due to the difference in thread pitch between the proximal and distal helical thread portions. A predetermined amount of compression / displacement between the two bone portions may be achieved based on the lengths of the proximal and distal helical thread portions and / or the difference in pitch between the proximal and distal helical thread portions.

[0313] In some embodiments, the multiple pitches may include one or more continuously varying pitches. For example, in some embodiments, the fastener 1400 may include a single helical thread (not shown) having a continuously varying pitch arranged around the shaft 1405 between the proximal end 1401 and the distal end 1402 of the shaft 1405.

[0314] In some embodiments, the continuously changing pitch can be reduced in a manner that changes continuously from the distal end 1402 of the shaft 1405 toward the proximal end 1401 of the shaft 1405.

[0315] In some embodiments, the continuously changing pitch can increase in a manner that changes continuously from the distal end 1402 of the shaft 1405 toward the proximal end 1401 of the shaft 1405.

[0316] In some embodiments, the multiple pitches may include a first pitch 1471 along the proximal shaft portion 1408 and a second pitch 1472 along the distal shaft portion 1409, as shown in Figure 24D.

[0317] In some embodiments, the first pitch 1471 and / or the second pitch 1472 may be discrete.

[0318] In some embodiments, the first pitch 1471 may be smaller than the second pitch 1472.

[0319] In some embodiments, the first pitch 1471 may be greater than the second pitch 1472.

[0320] In some embodiments, the thickness of the first helical thread 1410 may be increased or decreased in size, while the first pitch 1471 may remain constant regardless of the selected thickness of the first helical thread 1410.

[0321] In some embodiments, the thickness of the second helical thread 1420 may be increased or decreased in size, while the second pitch 1472 may remain constant regardless of the selected thickness of the second helical thread 1420.

[0322] In some embodiments, the fastener 1400 may have a “dual-start” thread structure (e.g., having a larger pitch) on the distal shaft portion 1409 and a “single-start” thread structure (e.g., having a smaller pitch) on the proximal shaft portion 1408. This configuration can achieve increased thread engagement with the bone toward the distal end 1402 of the fastener 1400, while maintaining compression with different thread pitches between the proximal end 1401 and the distal end 1402 of the fastener 1400.

[0323] In some embodiments, the fastener 1400 may have a “dual-start” thread structure (e.g., having a larger pitch) on the proximal shaft portion 1408 and a “single-start” thread structure (e.g., having a smaller pitch) on the distal shaft portion 1409. This configuration can achieve increased thread engagement with the bone toward the proximal end 1401 of the fastener 1400, while maintaining compression with different thread pitches between the proximal end 1401 and the distal end 1402 of the fastener 1400.

[0324] In some embodiments, the first concave undercut surface 1431 of the first helical thread 1410 may include a first inflection point 1491 at a first inflection point height 1495, and the first convex undercut surface 1441 of the first helical thread 1410 may include a second inflection point 1492 at a second inflection point height 1496.

[0325] In some embodiments, the second concave undercut surface 1432 of the second helical thread 1420 may include a third inflection point 1493 at a third inflection point height 1497, and the second convex undercut surface 1442 of the second helical thread 1420 may include a fourth inflection point 1494 at a fourth inflection point height 1498.

[0326] In some embodiments, the first inflection point height 1495 may be equal to the third inflection point height 1497, and the second inflection point height 1496 may be equal to the fourth inflection point height 1498. This configuration may help simplify the manufacturing process of helical threads having different thread heights, as will be described in more detail below with respect to Figures 27A-27C. However, it will also be understood that any / all of the first inflection point height 1495, the second inflection point height 1496, the third inflection point height 1497, and / or the fourth inflection point height 1498 may be manufactured selectively according to any height, independently of each other.

[0327] In some embodiments, as shown in Figure 24C, the distal end 1434 of the first helical thread 1410 may be “clocked” or “timed” with the proximal end 1433 of the second helical thread 1420. This can be achieved by selecting an appropriate distance between the proximal end 1433 of the second helical thread 1420 and the distal end 1434 of the first helical thread 1410, taking into account the thread pitch of the second helical thread 1420. In this way, the distal end 1434 of the first helical thread 1410 begins to screw into the bone when the proximal end 1433 of the second helical thread 1420 has finished screwing, facilitating the insertion of the fastener 1400 into the bone and / or reducing bone cross-cutting, thereby improving bone preservation.

[0328] In some embodiments, one or more cutting flutes 1407 may be shaped to push bone fragments (generated by the self-tapping action of the fastener) along the shaft 1405 in at least one direction as the fastener 1400 rotates within the bone.

[0329] For example, the cut flute 1407 formed on the distal shaft portion 1409 of the fastener 1400 in Figure 24C has a “left-handed” orientation 1445, while the first and second helical threads 1410, 1420 are “right-handed”. Therefore, when the fastener 1400 is inserted into the bone by rotating the fastener 1400 clockwise, the left-handed orientation 1445 of this distal cut flute 1407 will tend to push the bone fragment in a proximal-distal direction 1444, as shown in Figure 24C. This may help reduce friction / interference from the bone fragment and facilitate the insertion of the fastener 1400 into the bone.

[0330] Alternatively, the cutting flute 1607 formed on the distal shaft portion 1609 of the fastener 1600 in Figure 26C has a “right-handed” orientation 1646. Therefore, when the fastener 1600 is inserted into the bone by rotating the fastener 1600 clockwise, the right-handed orientation 1646 of the distal cutting flute 1607 tends to push the bone fragment distally from proximal 1645, as shown in Figure 26C. In this way, the bone fragment may be directed back toward the intermediate shaft portion 1619 (and / or toward the fracture in this region), which helps to promote bone growth / reconstruction and the healing process. Furthermore, in some embodiments, the cutting flute 1607 formed on the proximal shaft portion 1608 of the fastener 1600 in Figure 26C may have a “left-handed” orientation. Therefore, when the fastener 1600 is inserted into the bone by rotating it clockwise, the left-handed orientation of this proximal cutting flute 1607 tends to push the bone fragments in the proximal-to-distal direction 1644 as shown in Figure 26C. In this way, these bone fragments may be directed forward toward the intermediate shaft portion 1619 (and / or toward the fracture in this region), which helps to promote bone growth / reconstruction and the healing process.

[0331] In some embodiments, a first cutting flute 1407 may be formed on the proximal shaft portion 1408, and a second cutting flute 1407 may be formed on the distal shaft portion 1409.

[0332] In some embodiments, the first and second cutting flutes 1407 may be configured to push bone fragments along the shaft 1405 in a proximal to distal direction as the fastener 1400 is rotated into the bone.

[0333] In some embodiments, the first and second cutting flutes 1407 may be configured to push bone fragments along the shaft 1405 in a distal to proximal direction as the fastener 1400 is rotated into the bone.

[0334] In some embodiments, a first cutting flute 1407 may be configured to push bone fragments along the shaft 1405 in a proximal to distal direction as the fastener 1400 is rotated into the bone, and a second cutting flute 1407 may be configured to push bone fragments along the shaft 1405 in a distal to proximal direction as the fastener 1400 is rotated into the bone.

[0335] In some embodiments, a first cutting flute 1407 may be configured to push bone fragments along the shaft 1405 in a distal to proximal direction as the fastener 1400 is rotated into the bone, and a second cutting flute 1407 may be configured to push bone fragments along the shaft 1405 in a proximal to distal direction as the fastener 1400 is rotated into the bone.

[0336] In some embodiments, the proximal shaft portion 1408 may include one or more proximal reverse cutting flutes 1451 to facilitate the removal of the fastener 1400 from the bone after the healing process has occurred.

[0337] In some embodiments, the distal shaft portion 1409 may include one or more distal reverse cutting flutes 1452 to facilitate the removal of the fastener 1400 from the bone after the healing process has occurred.

[0338] Figures 25A–25D show various illustrations of a compression fastener, a bone fastener, or fastener 1500 according to another embodiment of the present disclosure. Specifically, Figure 25A is a front perspective view of fastener 1500, Figure 25B is a rear perspective view of fastener 1500, Figure 25C is a side view of fastener 1500, and Figure 25D is a side cross-sectional view of fastener 1500 taken along line CC in Figure 25C.

[0339] The fastener 1500 generally includes a shaft 1505 having a proximal end 1501, a distal end 1502, a longitudinal axis 1503, a proximal shaft portion 1508, a distal shaft portion 1509, an intermediate shaft portion 1519, a first helical thread 1510, a second helical thread 1520, one or more cut flutes 1507 (and / or reverse cut flutes), a central longitudinal passage 1529 that allows for guided insertion of the fastener 1500 on a K-wire or pin (not shown), and a torque connection interface 1506.

[0340] In some embodiments, the fastener 1500 may have a root diameter 1560 defined by the shaft 1505 of the fastener 1500.

[0341] In some embodiments, at least a portion of the valley diameter 1560 may be constant along the shaft 1505 of the fastener 1500.

[0342] In some embodiments, at least a portion of the valley diameter 1560 may vary along the shaft 1505 of the fastener 1500.

[0343] In some embodiments, the valley diameters of the distal shaft portion 1509, the intermediate shaft portion 1519, and / or the proximal shaft portion 1508 may be constant and / or substantially equal to each other.

[0344] In some embodiments, at least a portion of the valley diameter 1560 of the distal shaft portion 1509 may be smaller than the valley diameter of the intermediate shaft portion 1519 and / or the proximal shaft portion 1508.

[0345] In some embodiments, the fastener 1500 may have an outer diameter 1565 defined by one or more helical threads arranged around the shaft 1505 of the fastener 1500.

[0346] In some embodiments, one or more helical threads may be arranged around the shaft 1505, or a portion of the shaft 1505, as described above.

[0347] In some embodiments, the fastener 1500 may include a first helical thread 1510 and a second helical thread 1520 separated by a smooth shaft portion or intermediate shaft portion 1519.

[0348] In some embodiments, the fastener 1500 may include a single helical thread (not shown) arranged around the shaft 1505 between the proximal end 1501 and the distal end 1502 of the shaft 1505. In these embodiments, the single helical thread may span the distal shaft portion 1509, the intermediate shaft portion 1519, and the proximal shaft portion 1508. In these embodiments, the intermediate shaft portion 1519 may not be threadless / smooth.

[0349] In some embodiments, the fastener 1500 may include a plurality of helical threads (not shown) arranged around the shaft 1505 between the proximal end 1501 and the distal end 1502 of the shaft 1505. In these embodiments, some or all of the helical threads may span the distal shaft portion 1509, the intermediate shaft portion 1519, and / or the proximal shaft portion 1508. In these embodiments, the intermediate shaft portion 1519 may not be threadless / smooth.

[0350] In some embodiments, at least a portion of the outer diameter 1565 may be constant along one or more helical threads of the fastener 1500.

[0351] In some embodiments, at least a portion of the outer diameter 1565 may vary along one or more helical threads of the fastener 1500.

[0352] In some embodiments, the outer diameters 1565 of one or more helical threads around the distal shaft portion 1509, the intermediate shaft portion 1519, and / or the proximal shaft portion 1508 may be constant and / or substantially equal with respect to one another.

[0353] In some embodiments, the outer diameters 1565 of one or more helical threads around the distal shaft portion 1509, the intermediate shaft portion 1519, and / or the proximal shaft portion 1508 may not be constant with respect to one another, and / or may not be substantially equal.

[0354] In some embodiments, the outer diameter 1565 of one or more helical threads around the distal shaft portion 1509, the intermediate shaft portion 1519, and / or the proximal shaft portion 1508 may vary continuously.

[0355] In some embodiments, the outer diameter 1565 of one or more helical threads may increase in a manner that changes continuously from the distal end 1502 of the shaft 1505 toward the proximal end 1501 of the shaft 1505.

[0356] In some embodiments, the outer diameter 1565 of one or more helical threads may decrease in a manner that changes continuously from the distal end 1502 of the shaft 1505 toward the proximal end 1501 of the shaft 1505.

[0357] In some embodiments, the outer diameter 1565 of one or more helical threads may decrease in a manner that changes continuously from the distal end 1502 of the shaft 1505 toward the intermediate shaft portion 1519, and then increase in a manner that changes continuously from the intermediate shaft portion 1519 toward the proximal end 1501 of the shaft 1505.

[0358] In some embodiments, the outer diameter 1565 of one or more helical threads may increase in a manner that changes continuously from the distal end 1502 of the shaft 1505 toward the intermediate shaft portion 1519, and then decrease in a manner that changes continuously from the intermediate shaft portion 1519 toward the proximal end 1501 of the shaft 1505.

[0359] In some embodiments, the outer diameter 1565 or first height 1581 of the first helical thread 1510, located around the proximal shaft portion 1508, may be equal to the outer diameter 1565 or second height 1582 of the second helical thread 1520, located around the distal shaft portion 1509.

[0360] In some embodiments, the outer diameter 1565 or first height 1581 of the first helical thread 1510, located around the proximal shaft portion 1508, does not have to be equal to the outer diameter 1565 or second height 1582 of the second helical thread 1520, located around the distal shaft portion 1509.

[0361] In some embodiments, the outer diameter 1565 or first height 1581 of the first helical thread 1510, located around the proximal shaft portion 1508, may be greater than the outer diameter 1565 or second height 1582 of the second helical thread 1520, located around the distal shaft portion 1509. This may allow for greater bone engagement by the first helical thread 1510.

[0362] However, it will also be understood that in some embodiments, the outer diameter 1565 or first height 1581 of the first helical thread 1510, located around the proximal shaft portion 1508, may be smaller than the outer diameter 1565 or second height 1582 of the second helical thread 1520, located around the distal shaft portion 1509. This may allow for greater bone engagement by the second helical thread 1520.

[0363] In some embodiments, one or more helical threads arranged around the shaft 1505 may include at least one concave undercut surface. The at least one concave undercut surface may be angled toward one of the proximal end 1501 and the distal end 1502 of the shaft 1505.

[0364] In some embodiments, the first helical thread 1510 may include a first concave undercut surface 1531, and the second helical thread 1520 may include a second concave undercut surface 1532. The first and second concave undercut surfaces 1531 and 1532 may be angled toward one of the proximal end 1501 and the distal end 1502 of the shaft 1505.

[0365] However, it will also be understood that the fastener 1500 may include any screw structure, features, size, form, etc., described or intended herein, in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, one or more helical threads may include standard threads or reverse threads (or a combination thereof), "dual-start" thread configurations, crescent shapes, V-shapes, etc.

[0366] In some embodiments, one or more helical threads may include multiple pitches.

[0367] In some embodiments, the multiple pitches may include at least one first pitch along the proximal shaft portion 1508 and at least one second pitch along the distal shaft portion 1509.

[0368] In some embodiments, at least one first pitch and at least one second pitch may not be equal to each other. In this way, the distal helical thread portion having the second pitch may advance through the first bone portion into the second bone portion (not shown). Next, as the proximal helical thread portion having the first pitch enters the first bone portion, the continuous rotation of the fastener 1500 compresses the two bone portions toward each other due to the difference in thread pitch between the proximal and distal helical thread portions. A predetermined amount of compression / displacement between the two bone portions may be achieved based on the lengths of the proximal and distal helical thread portions and / or the difference in pitch between the proximal and distal helical thread portions.

[0369] In some embodiments, the pitches may include one or more continuously varying pitches. For example, in some embodiments, the fastener 1500 may include a single helical thread (not shown) arranged around the shaft 1505 between the proximal end 1501 and the distal end 1502 of the shaft 1505, with a continuously varying pitch.

[0370] In some embodiments, the continuously changing pitch can decrease in a manner that continuously changes from the distal end 1502 of the shaft 1505 toward the proximal end 1501 of the shaft 1505.

[0371] In some embodiments, the continuously changing pitch can be increased in a manner that changes continuously from the distal end 1502 of the shaft 1505 toward the proximal end 1501 of the shaft 1505.

[0372] In some embodiments, the multiple pitches may include a first pitch 1571 along the proximal shaft portion 1508 and a second pitch 1572 along the distal shaft portion 1509, as shown in Figure 25D.

[0373] In some embodiments, the first pitch 1571 and / or the second pitch 1572 may be discrete.

[0374] In some embodiments, the first pitch 1571 may be smaller than the second pitch 1572.

[0375] In some embodiments, the first pitch 1571 may be greater than the second pitch 1572.

[0376] In some embodiments, the thickness of the first helical thread 1510 may be increased or decreased in size, while the first pitch 1571 may remain constant with respect to the first helical thread 1510, regardless of the selected thickness.

[0377] In some embodiments, the thickness of the second helical thread 1520 may be increased or decreased in size, while the second pitch 1572 may remain constant with respect to the second helical thread 1520, regardless of the selected thickness.

[0378] In some embodiments, the fastener 1500 may have a "dual-start" thread structure (e.g., having a larger pitch) in the distal shaft portion 1509 and a "single-start" thread structure (e.g., having a smaller pitch) in the proximal shaft portion 1508. This configuration can achieve increased thread engagement with the bone toward the distal end 1502 of the fastener 1500, while maintaining compression between the proximal end 1501 and the distal end 1502 of the fastener 1500 due to the different thread pitches.

[0379] In some embodiments, the fastener 1500 may have a “dual-start” thread structure (e.g., having a larger pitch) in the proximal shaft portion 1508 and a “single-start” thread structure (e.g., having a smaller pitch) in the distal shaft portion 1509. This configuration can achieve increased thread engagement with the bone toward the proximal end 1501 of the fastener 1500, while maintaining compression between the proximal end 1501 and the distal end 1502 of the fastener 1500 due to the different thread pitches.

[0380] In some embodiments, the first concave undercut surface 1531 of the first helical thread 1510 may include a first inflection point 1591 at a first inflection point height 1595, and the first convex undercut surface 1541 of the first helical thread 1510 may include a second inflection point 1592 at a second inflection point height 1596.

[0381] In some embodiments, the second concave undercut surface 1532 of the second helical thread 1520 may include a third inflection point 1593 at a third inflection point height 1597, and the second convex undercut surface 1542 of the second helical thread 1520 may include a fourth inflection point 1594 at a fourth inflection point height 1598.

[0382] In some embodiments, the first inflection point height 1595 may be equal to the third inflection point height 1597, and the second inflection point height 1596 may be equal to the fourth inflection point height 1598. This configuration may help simplify the manufacturing process of helical threads with different thread heights, as will be described in more detail below with respect to Figures 27A-27C. However, it will also be understood that any / all of the first inflection point height 1595, the second inflection point height 1596, the third inflection point height 1597, and / or the fourth inflection point height 1598 may be manufactured selectively according to any height that is independent of each other.

[0383] In some embodiments, as shown in Figure 25C, the distal end 1534 of the first helical thread 1510 can be “clocked” or “timed” with the proximal end 1533 of the second helical thread 1520. This can be achieved by selecting an appropriate distance between the proximal end 1533 of the second helical thread 1520 and the distal end 1534 of the first helical thread 1510, taking into account the thread pitch of the second helical thread 1520. In this way, the distal end 1534 of the first helical thread 1510 can begin screwing into the bone when the proximal end 1533 of the second helical thread 1520 has finished, facilitating the insertion of the fastener 1500 into the bone and / or reducing bone cross-cutting, thereby improving bone preservation.

[0384] As described above, one or more cutting flutes 1507 may be shaped to push bone fragments (generated by the self-tapping action of the fastener 1500) along the shaft 1505 in at least one direction as the fastener 1500 rotates within the bone.

[0385] In some embodiments, the first cutting flute 1507 may be formed on the proximal shaft portion 1508, and the second cutting flute 1507 may be formed on the distal shaft portion 1509.

[0386] In some embodiments, the first and second cutting flutes 1507 may each be configured to push bone fragments along the shaft 1505 in a proximal to distal direction 1544 as the fastener 1500 is rotated within the bone.

[0387] In some embodiments, the first and second cutting flutes 1507 may be configured to push bone fragments along the shaft 1505 in a distal to proximal direction as the fastener 1500 is rotated within the bone.

[0388] In some embodiments, a first cutting flute 1507 may be configured to push a bone fragment along the shaft 1505 in a proximal to distal direction when the fastener 1500 is rotated within the bone, and a second cutting flute 1507 may be configured to push a bone fragment along the shaft 1505 in a distal to proximal direction when the fastener 1500 is rotated within the bone.

[0389] In some embodiments, a first cutting flute 1507 may be configured to push a bone fragment along the shaft 1505 in a distal to proximal direction when the fastener 1500 is rotated within the bone, and a second cutting flute 1507 may be configured to push a bone fragment along the shaft 1505 in a proximal to distal direction when the fastener 1500 is rotated within the bone.

[0390] In some embodiments, the proximal shaft portion 1508 may include one or more proximal reverse cutting flutes 1551 to facilitate the removal of the fastener 1500 from the bone after the healing process has occurred.

[0391] In some embodiments, the distal shaft portion 1509 may include one or more distal reverse cutting flutes 1552 to facilitate the removal of the fastener 1500 from the bone after the healing process has occurred.

[0392] Figures 26A–26D show various illustrations of a compression fastener, bone fastener, or fastener 1600 according to another embodiment of the present disclosure. Specifically, Figure 26A is a front perspective view of fastener 1600, Figure 26B is a rear perspective view of fastener 1600, Figure 26C is a side view of fastener 1600, and Figure 26D is a side cross-sectional view of fastener 1600 taken along line DD in Figure 26C.

[0393] The fastener 1600 may generally include a shaft 1605 having a proximal end 1601, a distal end 1602, a longitudinal axis 1603, a proximal shaft portion 1608, a distal shaft portion 1609, an intermediate shaft portion 1619, a first helical thread 1610, a second helical thread 1620, one or more cut flutes 1607 (and / or reverse cut flutes), a central longitudinal passage 1629 that allows for the guided insertion of the fastener 1600 onto a K-wire or pin (not shown), and a torque connection interface 1606.

[0394] In some embodiments, the fastener 1600 may have a root diameter 1660 defined by the shaft 1605 of the fastener 1600.

[0395] In some embodiments, at least a portion of the valley diameter 1660 may be constant along the shaft 1605 of the fastener 1600.

[0396] In some embodiments, at least a portion of the root diameter 1660 may vary along the shaft 1605 of the fastener 1600.

[0397] In some embodiments, the valley diameters of the distal shaft portion 1609, the intermediate shaft portion 1619, and / or the proximal shaft portion 1608 may be constant and / or substantially equal to each other.

[0398] In some embodiments, at least a portion of the valley diameter 1660 of the distal shaft portion 1609 may be smaller than the valley diameter of the intermediate shaft portion 1619 and / or the proximal shaft portion 1608.

[0399] In some embodiments, the fastener 1600 may have an outer diameter 1665 defined by one or more helical threads arranged around the shaft 1605 of the fastener 1600.

[0400] In some embodiments, as described above, one or more helical threads may be arranged around the shaft 1605 or a portion of the shaft 1605.

[0401] In some embodiments, the fastener 1600 may include a first helical thread 1610 and a second helical thread 1620 separated by a smooth shaft portion or intermediate shaft portion 1619.

[0402] In some embodiments, the fastener 1600 may include a single helical thread (not shown) arranged around the shaft 1605 between the proximal end 1601 and the distal end 1602 of the shaft 1605. In these embodiments, the single helical thread may span the distal shaft portion 1609, the intermediate shaft portion 1619, and the proximal shaft portion 1608. In these embodiments, the intermediate shaft portion 1619 may not be threadless / smooth.

[0403] In some embodiments, the fastener 1600 may include a plurality of helical threads (not shown) arranged around the shaft 1605 between the proximal end 1601 and the distal end 1602 of the shaft 1605. In these embodiments, some or all of the helical threads may span the distal shaft portion 1609, the intermediate shaft portion 1619, and / or the proximal shaft portion 1608. In these embodiments, the intermediate shaft portion 1619 may not be threadless / smooth.

[0404] In some embodiments, at least a portion of the outer diameter 1665 may be constant along one or more helical threads of the fastener 1600.

[0405] In some embodiments, at least a portion of the outer diameter 1665 may vary along one or more helical threads of the fastener 1600.

[0406] In some embodiments, the outer diameters 1665 of one or more helical threads around the distal shaft portion 1609, the intermediate shaft portion 1619, and / or the proximal shaft portion 1608 may be constant and / or substantially equal to one another.

[0407] In some embodiments, the outer diameters 1665 of one or more helical threads around the distal shaft portion 1609, the intermediate shaft portion 1619, and / or the proximal shaft portion 1608 may not be constant and / or substantially equal to one another.

[0408] In some embodiments, the outer diameter 1665 of one or more helical threads around the distal shaft portion 1609, the intermediate shaft portion 1619, and / or the proximal shaft portion 1608 may vary continuously.

[0409] In some embodiments, the outer diameter 1665 of one or more helical threads may increase in a manner that changes continuously from the distal end 1602 of the shaft 1605 toward the proximal end 1601 of the shaft 1605.

[0410] In some embodiments, the outer diameter 1665 of one or more helical threads may decrease in a manner that changes continuously from the distal end 1602 of the shaft 1605 toward the proximal end 1601 of the shaft 1605.

[0411] In some embodiments, the outer diameter 1665 of one or more helical threads may decrease in a manner that changes continuously from the distal end 1602 of the shaft 1605 toward the intermediate shaft portion 1619, and then increase in a manner that changes continuously from the intermediate shaft portion 1619 toward the proximal end 1601 of the shaft 1605.

[0412] In some embodiments, the outer diameter 1665 of one or more helical threads may increase in a manner that changes continuously from the distal end 1602 of the shaft 1605 toward the intermediate shaft portion 1619, and then decrease in a manner that changes continuously from the intermediate shaft portion 1619 toward the proximal end 1601 of the shaft 1605.

[0413] In some embodiments, the outer diameter 1665 or first height 1681 of the first helical thread 1610, located around the proximal shaft portion 1608, may be equal to the outer diameter 1665 or second height 1682 of the second helical thread 1620, located around the distal shaft portion 1609.

[0414] In some embodiments, the outer diameter 1665 or first height 1681 of the first helical thread 1610, located around the proximal shaft portion 1608, does not have to be equal to the outer diameter 1665 or second height 1682 of the second helical thread 1620, located around the distal shaft portion 1609.

[0415] In some embodiments, the outer diameter 1665 or first height 1681 of the first helical thread 1610, located around the proximal shaft portion 1608, may be greater than the outer diameter 1665 or second height 1682 of the second helical thread 1620, located around the distal shaft portion 1609. This may allow for greater bone engagement by the first helical thread 1610.

[0416] However, it will also be understood that in some embodiments, the outer diameter 1665 or first height 1681 of the first helical thread 1610, located around the proximal shaft portion 1608, may be smaller than the outer diameter 1665 or second height 1682 of the second helical thread 1620, located around the distal shaft portion 1609. This may allow for greater bone engagement by the second helical thread 1620.

[0417] In some embodiments, one or more helical threads arranged around the shaft 1605 may include at least one concave undercut surface. The at least one concave undercut surface may be angled toward one of the proximal end 1601 and the distal end 1602 of the shaft 1605.

[0418] In some embodiments, the first helical thread 1610 may include a first concave undercut surface 1631, and the second helical thread 1620 may include a second concave undercut surface 1632. The first and second concave undercut surfaces 1631 and 1632 may be angled toward one of the proximal end 1601 and distal end 1602 of the shaft 1605.

[0419] However, it will also be understood that the fastener 1600 may include any screw structure, features, size, form, etc., described or intended herein, in order to achieve optimal fixation within a given bone / tissue. For example, in some embodiments, one or more helical threads may include standard threads or reverse threads (or a combination thereof), "dual-start" thread configurations, crescent shapes, V-shapes, etc.

[0420] In some embodiments, one or more helical threads may include multiple pitches.

[0421] In some embodiments, the multiple pitches may include at least one first pitch along the proximal shaft portion 1608 and at least one second pitch along the distal shaft portion 1609.

[0422] In some embodiments, at least one first pitch and at least one second pitch do not have to be equal to each other. In this way, a distal helical thread portion having a second pitch can advance through a first bone portion to a second bone portion (not shown). Next, when a proximal helical thread portion having a first pitch enters the first bone portion, the continuous rotation of the fastener 1600 compresses the two bone portions toward each other due to the difference in thread pitch between the proximal and distal helical thread portions. A predetermined amount of compression / displacement between the two bone portions can be achieved based on the lengths of the proximal and distal helical thread portions and / or the difference in pitch between the proximal and distal helical thread portions.

[0423] In some embodiments, the pitches may include one or more continuously varying pitches. For example, in some embodiments, the fastener 1600 may include a single helical thread (not shown) arranged around the shaft 1605 between the proximal end 1601 and the distal end 1602 of the shaft 1605 and having a continuously varying pitch.

[0424] In some embodiments, the continuously changing pitch can decrease in a manner that continuously changes from the distal end 1602 of the shaft 1605 toward the proximal end 1601 of the shaft 1605.

[0425] In some embodiments, the continuously changing pitch can be increased in a manner that changes continuously from the distal end 1602 of the shaft 1605 toward the proximal end 1601 of the shaft 1605.

[0426] In some embodiments, the multiple pitches may include a first pitch 1671 along the proximal shaft portion 1608 and a second pitch 1672 along the distal shaft portion 1609, as shown in Figure 26D.

[0427] In some embodiments, the first pitch 1671 and / or the second pitch 1672 may be discrete.

[0428] In some embodiments, the first pitch 1671 may be smaller than the second pitch 1672.

[0429] In some embodiments, the first pitch 1671 may be greater than the second pitch 1672.

[0430] In some embodiments, the thickness of the first helical thread 1610 may be increased or decreased in size, while the first pitch 1671 may remain constant regardless of the thickness selected for the first helical thread 1610.

[0431] In some embodiments, the thickness of the second helical thread 1620 may be increased or decreased in size, while the second pitch 1672 may remain constant regardless of the selected thickness for the second helical thread 1620.

[0432] In some embodiments, the fastener 1600 may have a "dual-start" thread structure (e.g., having a larger pitch) in the distal shaft portion 1609 and a "single-start" thread structure (e.g., having a smaller pitch) in the proximal shaft portion 1608. This configuration can achieve increased thread engagement with the bone toward the distal end 1602 of the fastener 1600, while maintaining compression due to the different thread pitches between the proximal end 1601 and the distal end 1602 of the fastener 1600.

[0433] In some embodiments, the fastener 1600 may have a “dual-start” thread structure (e.g., having a larger pitch) in the proximal shaft portion 1608 and a “single-start” thread structure (e.g., having a smaller pitch) in the distal shaft portion 1609. This configuration achieves increased thread engagement with the bone toward the proximal end 1601 of the fastener 1600, while maintaining compression with different thread pitches between the proximal end 1601 and the distal end 1602 of the fastener 1600.

[0434] In some embodiments, the first concave undercut surface 1631 of the first helical thread 1610 may include a first inflection point 1691 at a first inflection point height 1695, and the first convex undercut surface 1641 of the first helical thread 1610 may include a second inflection point 1692 at a second inflection point height 1696.

[0435] In some embodiments, the second concave undercut surface 1632 of the second helical thread 1620 may include a third inflection point 1693 at a third inflection point height 1697, and the second convex undercut surface 1642 of the second helical thread 1620 may include a fourth inflection point 1694 at a fourth inflection point height 1698.

[0436] In some embodiments, the first inflection point height 1695 may be equal to the third inflection point height 1697, and the second inflection point height 1696 may be equal to the fourth inflection point height 1698. This configuration may help simplify the manufacturing process of helical threads with different thread heights, as will be described in more detail below with respect to 27A-27C. However, it will also be understood that any / all of the first inflection point height 1695, the second inflection point height 1696, the third inflection point height 1697, and / or the fourth inflection point height 1698 may be manufactured selectively according to any height, independently of each other.

[0437] In some embodiments, as shown in Figure 26C, the distal end 1634 of the first helical thread 1610 may be “clocked” or “timed” with the proximal end 1633 of the second helical thread 1620. This can be achieved by selecting an appropriate distance between the proximal end 1633 of the second helical thread 1620 and the distal end 1634 of the first helical thread 1610, taking into account the thread pitch of the second helical thread 1620. In this way, the distal end 1634 of the first helical thread 1610 begins screwing into the bone when the proximal end 1633 of the second helical thread 1620 ends, facilitating the insertion of the fastener 1600 into the bone and / or reducing cross-cutting, thereby improving bone preservation.

[0438] As described above, one or more cutting flutes 1607 may be shaped to push bone fragments (generated by the self-tapping action of the fastener 1600) along the shaft 1605 in at least one direction as the fastener 1600 rotates within the bone.

[0439] In some embodiments, the first cutting flute 1607 may be formed on the proximal shaft portion 1608, and the second cutting flute 1607 may be formed on the distal shaft portion 1609.

[0440] In some embodiments, the first and second cutting flutes 1607 may be configured to push bone fragments along the shaft 1605 in a proximal to distal direction as the fastener 1600 is rotated within the bone.

[0441] In some embodiments, the first and second cutting flutes 1607 may be configured to push bone fragments along the shaft 1605 in a distal to proximal direction as the fastener 1600 is rotated within the bone.

[0442] In some embodiments, a first cutting flute 1607 may be configured to push bone fragments along the shaft 1605 in a proximal to distal direction as the fastener 1600 rotates within the bone, and a second cutting flute 1607 may be configured to push bone fragments along the shaft 1605 in a distal to proximal direction as the fastener 1600 rotates within the bone.

[0443] In some embodiments, a first cutting flute 1607 may be configured to push bone fragments along the shaft 1605 in a distal to proximal direction as the fastener 1600 rotates within the bone, and a second cutting flute 1607 may be configured to push bone fragments along the shaft 1605 in a proximal to distal direction as the fastener 1600 rotates within the bone.

[0444] In some embodiments, the proximal shaft portion 1608 may include one or more proximal reverse cutting flutes 1651 to facilitate the removal of the fastener 1600 from the bone after the healing process has occurred.

[0445] In some embodiments, the distal shaft portion 1609 may include one or more distal reverse cutting flutes 1652 to facilitate the removal of the fastener 1600 from the bone after the healing process has occurred.

[0446] Figures 27A and 27B show a simplified cutting process for two helical threads on different parts of a shaft having different heights and pitches. Figure 27C shows the helical threads shown in Figures 27A and 27B superimposed on each other, and Figure 27D shows the helical threads of Figures 27A and 27B superimposed on each other, but utilizing the crescent shape shown in Figure 2. Figures 27A–27D will be described in relation to the helical thread shown in Figure 26 as a non-limiting example for illustrative purposes only. It will be understood that these cutting processes may be applied to any other helical thread designs disclosed or intended herein.

[0447] Figure 27A shows the cutting process for a first helical thread 1610 having a first height 1681 and a first pitch 1671 (see, for example, Figure 26D), and Figure 27B shows the cutting process for a second helical thread 1620 having a second height 1682 and a second pitch 1672. In this embodiment, the first height 1681 may be greater than the second height 1682, and the second pitch 1672 may be greater than the first pitch 1671.

[0448] Figure 26D also shows the first inflection point 1691 at the first inflection point height 1695, the second inflection point 1692 at the second inflection point height 1696, the third inflection point 1693 at the third inflection point height 1697, and the fourth inflection point 1694 at the fourth inflection point height 1698.

[0449] In some embodiments, the first inflection point height 1695 may be equal to the third inflection point height 1697, and the second inflection point height 1696 may be equal to the fourth inflection point height 1698. This configuration may help simplify the manufacturing process of the first helical thread 1610 and the second helical thread 1620 by reducing the need to change cutting tools during the manufacturing process.

[0450] For example, in the first step of the manufacturing process, as shown in Figure 27A, a first cutting tool 1701 may be used to machine a first notch in the shaft 1605 of the fastener 1600, initiating the formation of the first helical thread 1610. In some embodiments, the shape outlined by the four lines 1715 shown in Figure 27A may substantially correspond to the shape of the first cutting tool 1701 during this first step of the cutting process. In this step, the first cutting tool 1701 may be positioned on the proximal shaft portion of a substantially cylindrical base material having a proximal end and a distal end (not shown), the substantially cylindrical base material may be rotated around its longitudinal axis, and the first cutting tool 1701 may be moved along the proximal shaft portion to form a fourth open surface 114 of the first helical thread 1610, the first helical thread 1610 having a first pitch 1671 and a first height 1681.

[0451] In some embodiments, the manufacturing process may proceed to a second step in which a first cutting tool 1701 is used to machine a second notch into the shaft 1605 of the fastener 1600, as shown in Figure 27B, thereby initiating the formation of a second helical thread 1620. In some embodiments, the shape outlined by the four lines 1710 shown in Figure 27A may substantially correspond to the shape of the first cutting tool 1701 during this second step of the cutting process (for example, moving the first cutting tool 1701 shown in Figure 27A along the shaft 1605 would form a wide notch in this portion of the second helical thread 1620, as shown in Figure 27B). In this step, the first cutting tool 1701 may be positioned on the distal shaft portion of a substantially cylindrical base material, the substantially cylindrical base material may be rotated around its longitudinal axis, and the first cutting tool 1701 may be moved along the distal shaft portion to form a fourth open surface 114 of the second helical thread 1620, the second helical thread 1620 having a second pitch 1672 and a second height 1682.

[0452] In some embodiments, the manufacturing process may proceed to a third step in which a second cutting tool 1702 is used to machine a third notch in the shaft 1605 of the fastener 1600, as shown in Figure 27A, and continues to form the first helical thread 1610 (for example, forming a first concave undercut surface 1631, as shown in Figure 26D). In some embodiments, the shape outlined by the five lines 1730 shown in Figure 27A may substantially correspond to the shape of the second cutting tool 1702 during this third step of the cutting process. In this step, the second cutting tool 1702 may be positioned on the proximal shaft portion of a substantially cylindrical base material, the substantially cylindrical base material may be rotated around its longitudinal axis, and the second cutting tool 1702 may be moved along the proximal shaft portion to form the first undercut surface 111 and the second undercut surface 112 of the first helical thread 1610.

[0453] In some embodiments, the manufacturing process may proceed to a fourth step, as shown in Figure 27B, in which a second cutting tool 1702 is used to machine a fourth notch into the shaft 1605 of the fastener 1600, continuing to form the second helical thread 1620 (for example, forming a second concave undercut surface 1632, as shown in Figure 26D). In this step, the second cutting tool 1702 may be positioned on the distal shaft portion of a substantially cylindrical base material, the substantially cylindrical base material may be rotated around its longitudinal axis, and the second cutting tool 1702 may be moved along the distal shaft portion to form the first undercut surface 111 and the second undercut surface 112 of the second helical thread 1620.

[0454] In some embodiments, the manufacturing process may proceed to a fifth step, as shown in Figure 27A, in which a third cutting tool 1703 is used to machine a fifth notch into the shaft 1605 of the fastener 1600, continuing to form the first helical thread 1610 (for example, forming a first convex undercut surface 1641, as shown in Figure 26D). In some embodiments, the shape outlined by the five lines 1720 shown in Figure 27A may substantially correspond to the shape of the third cutting tool 1703 during this fifth step of the cutting process. In this step, the third cutting tool 1703 may be positioned on the proximal shaft portion of a substantially cylindrical base material, the substantially cylindrical base material may be rotated around its longitudinal axis, and the third cutting tool 1703 may be moved along the proximal shaft portion to form a third undercut surface 113 of the first helical thread 1610.

[0455] In some embodiments, the manufacturing process may proceed to a sixth step, as shown in Figure 27B, in which a third cutting tool 1703 is used to machine a sixth notch into the shaft 1605 of the fastener 1600, continuing to form the second helical thread 1620 (for example, forming a second convex undercut surface 1642, as shown in Figure 26D). In this step, the third cutting tool 1703 may be positioned on the distal shaft portion of a substantially cylindrical base material, the substantially cylindrical base material may be rotated around its longitudinal axis, the third cutting tool 1703 may be moved parallel to the distal shaft portion, forming a third undercut surface 113 of the second helical thread 1620, and the manufacturing process may end.

[0456] In some embodiments, the manufacturing process may also include rotating a substantially cylindrical substrate and moving a first cutting tool 1701 along a proximal shaft portion to form a fifth open surface 129 of the first helical thread 1610.

[0457] In some embodiments, the manufacturing process may also include rotating a substantially cylindrical base material and moving a first cutting tool 1701 along a distal shaft portion to form a fifth open surface 129 of the second helical thread 1620.

[0458] In some embodiments, the manufacturing process may also include positioning a cutting tool on an intermediate shaft portion of a substantially cylindrical substrate, rotating the substantially cylindrical substrate, and moving the cutting tool along the intermediate shaft portion to form a smooth shaft portion between the first helical threads 1610 and the second helical threads 1620.

[0459] In some embodiments, the first undercut surface 111 and the second undercut surface 112 of the first helical thread 1610 may include a first concave undercut surface 1631 (see, for example, Figure 26D), the first undercut surface 111 and the second undercut surface 112 of the second helical thread 1620 may include a second concave undercut surface 1632, the third undercut surface 113 and the fourth open surface 114 of the first helical thread 1610 may include a first convex undercut surface 1641, and the third undercut surface 113 and the fourth open surface 114 of the second helical thread 1620 may include a second convex undercut surface 1642.

[0460] In some embodiments, the first and second concave undercut surfaces 1631, 1632, and the first and second convex undercut surfaces 1641, 1642 may have a crescent shape directed toward one of the proximal or distal ends of a substantially cylindrical substrate.

[0461] In some embodiments, the first and second concave undercut surfaces 1631, 1632, and the first and second convex undercut surfaces 1641, 1642 may include a V-shape directed toward one of the proximal and distal ends of a substantially cylindrical substrate.

[0462] In some embodiments, the first concave undercut surface 1631 may include a first inflection point 1691 at a first inflection point height 1695 (see, for example, Figures 26D-27D), the first convex undercut surface 1641 may include a second inflection point 1692 at a second inflection point height 1696, the second concave undercut surface 1632 may include a third inflection point 1693 at a third inflection point height 1697, and the second convex undercut surface 1642 may include a fourth inflection point 1694 at a fourth inflection point height 1698.

[0463] In some embodiments, the first inflection point height 1695 may be equal to the third inflection point height 1697, and the second inflection point height 1696 may be equal to the fourth inflection point height 1698.

[0464] In some embodiments, the first pitch 1671 of the first helical thread 1610 may be smaller than the second pitch 1672 of the second helical thread 1620.

[0465] In some embodiments, the first pitch 1671 of the first helical thread 1610 may be greater than the second pitch 1672 of the second helical thread 1620.

[0466] In some embodiments, the first height 1681 of the first helical thread 1610 may be greater than the second height 1682 of the second helical thread 1620.

[0467] In some embodiments, the first height 1681 of the first helical thread 1610 may be smaller than the second height 1682 of the second helical thread 1620.

[0468] In some embodiments, the proximal end 1633 of the second helical thread 1620 may be timed to the distal end 1634 of the first helical thread 1620 (see, for example, Figure 26C as described above).

[0469] In some embodiments, as described above, the first pitch 1671 of the first helical thread 1610 may remain constant regardless of the selected thickness of the first helical thread 1610.

[0470] In some embodiments, the second pitch 1672 of the second helical thread 1620 may remain constant regardless of the selected thickness of the second helical thread 1620.

[0471] In some embodiments, a method for manufacturing a compression fastener may generally include forming a first helical thread 1610 positioned around a proximal shaft portion of a substantially cylindrical base material (not shown), and forming a second helical thread 1620 positioned around a distal shaft portion of a substantially cylindrical base material. The first helical thread 1610 may include a first inner portion 1811 projecting from a substantially cylindrical base material at a first height 1831, and an outer portion 1812 extending from the first inner portion 1811 at a second height 1832 greater than the first height 1831. The second helical thread 1620 may include a second inner portion 1822 projecting from a substantially cylindrical base material at a third height 1833. In some embodiments, the second height 1832 of the outer portion 1812 may be greater than the third height 1833 of the second inner portion 1822, and the third height 1833 of the second inner portion 1822 may be equal to the first height 1831 of the first inner portion 1811.

[0472] In some embodiments, the first inner portion 1811 of the first helical thread 1610 may include a first shape, and the second inner portion 1822 of the second helical thread 1620 may include a second shape.

[0473] In some embodiments, the first shape and the second shape may be substantially equivalent to each other.

[0474] In some embodiments, the first and second shapes may include crescent shapes that can be directed toward either the proximal or distal end of a substantially cylindrical substrate.

[0475] In some embodiments, the first and second shapes may include a V-shape that can be directed toward either the proximal or distal end of a substantially cylindrical substrate.

[0476] In some embodiments, the first inner portion 1811 may include a first inflection point 1691 at a first inflection point height 1695 and a second inflection point 1692 at a second inflection point height 1696.

[0477] In some embodiments, the second inner portion 1822 may include a third inflection point 1693 at a third inflection point height 1697 and a fourth inflection point 1694 at a fourth inflection point height 1698.

[0478] In some embodiments, the first inflection point height 1695 may be equal to the third inflection point height 1697, and the second inflection point height 1696 may be equal to the fourth inflection point height 1698.

[0479] Any procedure / method disclosed herein includes one or more steps or actions for performing the described method. The steps and / or actions of the method are interchangeable. In other words, the order and / or use of any particular steps and / or actions may be changed unless a particular order of steps or actions is required for the proper operation of the embodiment.

[0480] Any implant or fastener described or intended herein may be configured to be removable and replaceable during prosthetic treatment by simply loosening the screw of the implant / fastener and removing the implant / fastener from the bone / tissue in which the implant resides. Furthermore, any implant / fastener described herein may be advantageously removed from bone during the removal process without removing any visible amount of bone, thus preserving bone. In this way, the implant / fastener may be mechanically integrated with the bone, while not cemented to the bone or integrated through intrinsic bone growth, providing an immediate, removable connection between the implant and the bone. Therefore, prosthetic treatment using implants / fasteners described herein may result in less bone trauma and improved patient therapeutic effects. However, it will also be understood that any implant / fastener described or intended herein may also be used with cement, if desired.

[0481] Throughout this specification, any reference to “an embodiment” or “that embodiment” means that a particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. Therefore, not all quotations or variations thereof referenced throughout this specification necessarily refer to the same embodiment.

[0482] Similarly, it should be understood that in the above description of embodiments, various features are sometimes combined into 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 those explicitly enumerated in that embodiment. Rather, aspects of the invention lie in combinations of fewer features than all of the features of any single embodiment disclosed above.

[0483] The enumeration of the term “first” with respect to features or elements does not necessarily imply the presence of a second or additional such feature or element. Elements enumerated in means-plus-function form are intended to be interpreted in accordance with Section 112(f) of the United States Patent Act. It will be apparent to those skilled in the art that modifications can be made to the details of the embodiments described herein without departing from the fundamental principles set forth herein.

[0484] The terms “connected,” “joined,” and “communicate” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be functionally joined to one another even if they are not in direct contact with each other. The term “joined” may include components joined to each other through integral formation, as well as components joined to each other in a detachable and / or non-detachable manner. The term “contacting” refers to items that may be in direct physical contact with each other, even if the items are not necessarily attached together. The term “fluid communication” refers to two or more structures connected so that a fluid in one structure can flow into another structure. Furthermore, the term “substantially” as defined herein means within ±20% of a target value, measurement, or desired characteristic.

[0485] While specific embodiments and applications of this disclosure have been illustrated and described, it should also be understood that the scope of this disclosure is not limited to the exact configurations and components disclosed herein. Various modifications, changes, and variations, which will be apparent to those skilled in the art, may be made to the arrangement, operation, and details of the devices, systems, and methods disclosed herein.

Claims

1. A bone implant, wherein the bone implant includes a shaft, The aforementioned shaft is The proximal end and The distal end and The longitudinal axis, The proximal shaft portion, The first valley path and A first helical thread, which is arranged around the proximal shaft portion and defines the first outer diameter of the proximal shaft portion, wherein the first helical thread includes a first concave undercut surface, and the proximal shaft portion includes the first helical thread, The distal shaft portion, The second valley path, A second helical thread, positioned around the distal shaft portion and defining a second outer diameter of the distal shaft portion, wherein the second helical thread includes a second concave undercut surface, and the distal shaft portion includes the second helical thread, The first concave undercut surface and the second concave undercut surface are angled toward the distal end of the shaft. The second valley diameter of the distal shaft portion is smaller than the first valley diameter of the proximal shaft portion. A bone implant characterized in that the second outer diameter of the distal shaft portion is smaller than the first outer diameter of the proximal shaft portion.

2. A bone implant according to claim 1, wherein the proximal end of the shaft includes a flange component, the flange component is The surface facing the bone, A bone implant characterized by including a surface facing the instrument.

3. A bone implant according to claim 2, characterized in that the surface facing the bone includes a convex surface.

4. A bone implant according to claim 3, characterized in that the surface facing the bone includes a hemispherical surface.

5. A bone implant according to claim 1, characterized in that a mounting configuration configured for fixing an instrument is included at the proximal end of the shaft.

6. A bone implant according to claim 5, The aforementioned mounting configuration includes a post, The bone implant is characterized in that the device includes an articular head having a convex hemispherical articular surface, and the articular head is configured to be detachably coupled to the post.

7. A bone implant according to claim 6, The aforementioned mounting configuration includes an implant recess, The bone implant is characterized in that the device includes an insert having a concave hemispherical articular surface, and the insert is configured to be removably coupled to the implant recess.

8. A bone implant, wherein the bone implant is A shaft comprising a proximal end, a distal end, a longitudinal axis, a root diameter, and a threaded shaft portion, An articulating member positioned at the proximal end of the shaft, A helical screw, which is arranged around the shaft and defines the length of the threaded portion of the shaft, the helical screw includes a concave undercut surface, The aforementioned concave undercut surface is angled toward the distal end of the shaft. A bone implant characterized in that the ratio of the length of the threaded shaft portion to the root diameter of the shaft is less than 1.

50.

9. A bone implant according to claim 8, characterized in that the ratio of the length of the threaded shaft portion to the root diameter of the shaft is less than 1.

25.

10. A bone implant according to claim 8, characterized in that the ratio of the length of the threaded shaft portion to the root diameter of the shaft is less than 1.

10.

11. A bone implant according to claim 8, characterized in that the ratio of the length of the threaded shaft portion to the root diameter of the shaft is equal to 1.

0.

12. A bone implant according to claim 8, characterized in that the ratio of the length of the threaded shaft portion to the root diameter of the shaft is less than 1.

0.

13. In the bone implant according to claim 8, further, A bone implant characterized in that a flange component is included at the proximal end of the shaft, and the flange component includes a surface that faces bone and a surface that faces an instrument.

14. A bone implant according to claim 8, characterized in that the joint movement member is configured to be detachably coupled to the mounting configuration of the proximal end of the shaft.

15. A shoulder joint implant, wherein the shoulder joint implant is A shaft comprising a proximal end, a distal end, and a longitudinal axis, A helical thread arranged around the shaft along the longitudinal axis between the proximal and distal ends of the shaft, wherein the helical thread includes a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface. The first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft. The second undercut surface and the fourth open surface are angled toward the other of the proximal and distal ends of the shaft, and the helical threads are A shoulder joint implant characterized by comprising a shoulder joint device having an articular surface at the proximal end of the shaft.

16. A shoulder joint implant according to claim 15, The aforementioned shoulder joint device includes a glenoid fossa humeral head prosthesis, The shoulder joint implant is characterized in that the aforementioned articular surface includes a convex, hemispherical articular surface.

17. A shoulder joint implant according to claim 15, The aforementioned shoulder joint device includes a humeral head prosthesis, The shoulder joint implant is characterized in that the aforementioned articular surface includes a convex, hemispherical articular surface.

18. A shoulder joint implant according to claim 15, The aforementioned shoulder joint device includes a glenoid prosthesis, The shoulder joint implant is characterized in that the articular surface includes a concave, hemispherical articular surface.

19. The shoulder joint implant according to claim 15, wherein the shoulder joint device is Including a humeral insertion prosthesis, The shoulder joint implant is characterized in that the articular surface includes a concave, hemispherical articular surface.

20. A shoulder joint implant according to claim 15, wherein the proximal end of the shaft includes a flange component, the flange component having a surface that faces bone and a surface that faces an instrument.

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