JP2023551178A - Fastening devices, systems, and methods - Google Patents

Abstract

The femoral fixation device may include a shaft and a helical screw disposed about the shaft between a first location and a second location along the shaft. The helical thread may include a concave undercut surface. The femoral fixation device is configured such that when the femoral fixation device is implanted within the neck and head of the femur, the first location, the second location, and the helical screw therebetween are disposed within the head of the femur. the concave undercut surface may be oriented toward the proximal end of the femoral fixation device, the concave undercut surface applying at least one force from the head of the femur to the neck of the femur. may be configured to communicate.

Description

TECHNICAL FIELD This disclosure relates to fastening devices, systems, and methods. More specifically, the present disclosure relates to fastening devices with improved thread designs and fastening systems/methods that utilize fastening devices with improved thread designs.

Surgical procedures involving fasteners implanted within bone or other tissue can lose value 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 screw designs fail to provide sufficient fastener fixation to overcome these multi-axial force and off-axis loading scenarios.

Therefore, a fastener with an improved screw design is desired to improve bone fixation and load distribution between the bone/fastener interface that experiences multi-axial and off-load conditions.

SUMMARY The various fastening devices, systems, and methods of the present disclosure address, in accordance with the current state of the art, particularly those areas of the art that are not yet fully resolved by currently available fastening devices, systems, and methods. It was developed in response to the problems and needs of In some embodiments, the fastening devices, systems, and methods of the present disclosure may provide improved bone fixation and load distribution between the bone/fastener interface under multi-axial and off-load conditions.

In some embodiments, a femoral fixation device may include a shaft having a proximal end, a distal end, and a longitudinal axis. The femoral fixation device may also include a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft. The helical thread may include a first undercut surface and a second undercut surface. The femoral fixation device is configured such that when the femoral fixation device is implanted within the neck and head of the femur, (1) the first location, the second location, and the helical screw therebetween are (2) the first undercut surface may be angled toward one of the proximal and distal ends of the shaft; (3) the second undercut surface may be disposed within the head; (4) the first and second undercut surfaces direct at least one force away from the femoral head such that the cut surfaces may be angled toward the other of the proximal and distal ends of the shaft; Can be configured such that it can be configured to communicate to the femoral neck.

In some embodiments of the femoral fixation device, the first undercut surface may be angled toward the proximal end of the shaft and the second undercut surface may be angled toward the distal end of the shaft. Can be angled.

In some embodiments of the femoral fixation device, the helical screw is oriented toward the proximal end of the shaft when the femoral fixation device is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft. and at least one chevron shape.

In some embodiments of the femoral fixation device, the helical screw may include multiple chevron shapes oriented toward the proximal end of the shaft.

In some embodiments of the femoral fixation device, the helical screw is oriented toward the proximal end of the shaft when the femoral fixation device is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft. and at least one partial crescent shape.

In some embodiments of the femoral fixation device, the helical screw may include a plurality of partial crescent shapes oriented toward the proximal end of the shaft.

In some embodiments of the femoral fixation device, the proximal end of the shaft may include a headless cylindrical shape.

In some embodiments, the femoral fixation assembly may include a femoral fastener and a femoral support member. A femoral fastener may include a shaft having a proximal end, a distal end, and a longitudinal axis. The femoral fastener may also include a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft. The helical thread may include a concave undercut surface. The femoral support member may include a proximal end, a distal end, a longitudinal axis, and a passageway formed through the femoral support member at an angle relative to the longitudinal axis of the femoral support member. In some embodiments, when the femoral fastener is implanted within the neck and head of the femur and the femoral support member is implanted along the longitudinal axis of the femur, at least a portion of the shaft is implanted within the neck and head of the femur. The concave undercut surface may be slidably received within the passageway of the bone support member, the concave undercut surface being oriented toward the proximal end of the femoral fastener and extending from the head of the femur to the neck of the femur at least once. may be configured to transmit two forces.

In some embodiments of the femoral fixation assembly, the concave undercut surface may include at least one substantially flat surface.

In some embodiments of the femoral fixation assembly, the concave undercut surface may include a plurality of flat surfaces that are angled with respect to each other.

In some embodiments of the femoral fixation assembly, along a plane intersecting the longitudinal axis of the shaft, when the femoral fastener is viewed in cross-section, a concave undercut surface is located at the proximal end of the shaft. The structure may include at least one chevron shape oriented in the direction.

In some embodiments of the femoral fixation assembly, the concave undercut surface may include at least one curved surface.

In some embodiments of the femoral fixation assembly, along a plane intersecting the longitudinal axis of the shaft, when the femoral fastener is viewed in cross-section, a concave undercut surface is located at the proximal end of the shaft. and at least one partial crescent shape oriented toward.

In some embodiments of the femoral fixation assembly, the concave undercut surface is proximal to the femoral fastener when the femoral fastener is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft. It may include at least one curved shape having a distally oriented intermediate portion.

In some embodiments, the femoral fixation assembly may include a femoral fastener, a femoral support member, and a stop member. A femoral fastener may include a shaft having a proximal end, a distal end, and a longitudinal axis. The femoral fastener may include a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft. The femoral support member can include a proximal end, a distal end, a longitudinal axis, and a passageway. The passageway may include a first opening and a second opening opposite the first opening. The passageway may be formed through the femoral support member at an angle relative to the longitudinal axis of the femoral support member. The stop member may include a proximal end, a distal end, a longitudinal axis, and a stop member projection having a preselected length. In some embodiments, when the femoral fastener is implanted within the neck and head of the femur and the femoral support member is oriented relative to the longitudinal axis of the femur, (1) at least one of the shafts (2) at least a portion of the stop member may be slidably received within the passageway through the first opening; (3) at least a portion of the stop member may be received within the passageway through the second opening; Based on the preselected length of the stop member protrusion, a space having a predetermined length may be formed within the passageway between the distal end of the stop member and the proximal end of the shaft.

In some embodiments of the femoral fixation assembly, the femoral support member can be a bone plate.

In some embodiments of the femoral fixation assembly, the femoral support member can be an intramedullary nail.

In some embodiments of the femoral fixation assembly, the angle of the passageway relative to the longitudinal axis of the femoral support member can be acute.

In some embodiments of the femoral fixation assembly, the predetermined length of the space within the passageway can be greater than zero.

In some embodiments of the femoral fixation assembly, the predetermined length of the space within the passageway may be zero.

In some embodiments, a method of implanting a femoral fixation device within a femur includes forming a bone tunnel through the neck of the femur to the head of the femur; and inserting the femoral fixation device into the bone tunnel. may include inserting into. The femoral fixation device may include a shaft having a proximal end, a distal end, and a longitudinal axis. The femoral fixation device may also include a helical screw disposed about the shaft between a first location and a second location along the shaft. The helical thread may include a concave undercut surface oriented toward the proximal end of the shaft. The method also includes a helical screw in the head of the femur such that the concave undercut surface can be positioned to transmit at least one force from the head of the femur to the neck of the femur. It may include positioning a portion of the shaft.

In some embodiments, the method may also include forming a female bone screw around the bone tunnel that may be configured to receive a helical screw therein.

In some embodiments of the method, placing the portion of the shaft that includes the helical screw within the head of the femur further includes rotating the shaft to rotate the portion of the shaft that includes the helical screw into the female bone that is placed around the bone tunnel. It may include inserting a helical screw into the screw.

In some embodiments, the method also includes inserting the proximal end of the shaft into the first opening of the passageway formed through the femoral support member, oriented relative to the longitudinal axis of the femur. may include.

In some embodiments, the method also includes inserting a distal end of the stop member into a second opening of the passageway, opposite the first opening, based on the preselected length of the stop member. , may include forming a space having a predetermined length within the passageway between the distal end of the stop member and the proximal end of the shaft.

In some embodiments, a pedicle fastener may include a shaft and a helical screw. The shaft can have a proximal end, a distal end, a longitudinal axis, and a small diameter. The helical thread may be disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a first undercut surface and a second undercut surface. The first undercut surface may be angled toward one of the proximal and distal ends of the shaft, and the second undercut surface may be angled toward the other of the proximal and distal ends of the shaft. The shaft can be angled and the shaft can be of constant diameter.

In some embodiments, the attachment arrangement may be coupled to the proximal end of the shaft and configured to be secured to the instrument.

In some embodiments, the mounting arrangement may include a multi-axis head having a first hemispherical surface.

In some embodiments, the instrument is configured to engage the first hemispherical surface of the multi-axial head to secure the discrete tulips to the multi-axial head in any of a variety of relative orientations. A separate tulip may be included having a second hemisphere.

In some embodiments, the separate tulip may include at least one aperture and a locking member configured to secure the rod received through the at least one aperture to the separate tulip.

In some embodiments, the attachment arrangement may include an integrated tulip having at least one aperture configured to receive at least a portion of the instrument therethrough.

In some embodiments, the device may include a rod receivable through at least one aperture of the integrated tulip, the integrated tulip configured to secure the rod to the integrated tulip. A locking member may be included.

In some embodiments, a method of preventing bone rupture may include forming a hole in the bone having the diameter of a bone hole and inserting a bone fastener into the hole. A bone fastener may include a shaft and a helical screw. The shaft can have a proximal end, a distal end, a longitudinal axis, and a small diameter. The helical thread may be disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a first undercut surface and a second undercut surface. The first undercut surface may be angled toward one of the proximal and distal ends of the shaft. The second undercut surface may be angled toward the other of the proximal and distal ends of the shaft, such that the smaller diameter of the main portion of the shaft imparts a radially outward loading force that is applied to the bone. It can be no larger than the diameter of the bone hole to reduce and prevent bone rupture.

In some embodiments, the minor diameter of the main portion of the shaft may be equal to the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be 0 mm to 0.1 mm less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be at least 0.1 mm less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be at least 0.2 mm less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft may be constant.

In some embodiments, a bone fastener may include a shaft and a helical screw. The shaft can have a proximal end, a distal end, a longitudinal axis, and a small diameter. A helical thread may be disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft and define a large diameter of the bone fastener. The helical thread may include a first undercut surface and a second undercut surface. The first undercut surface may be angled toward one of the proximal and distal ends of the shaft. The second undercut surface may be angled toward the other of the proximal and distal ends of the shaft, and the ratio of the large diameter to the small diameter may be less than 1.50.

In some embodiments, the ratio of large diameter to small diameter can be less than 1.25.

In some embodiments, the ratio of large diameter to small diameter can be less than 1.10.

In some embodiments, the ratio of large diameter to small diameter can be less than 1.05.

In some embodiments, at least a portion of the shaft may be configured to be received in an intramedullary canal of a bone.

In some embodiments, the bone fastener may also include an attachment arrangement at the proximal end of the shaft configured to be adjustably secured to the instrument.

In some embodiments, a pedicle fastener may include a shaft, a helical screw, and an integrated attachment arrangement. The shaft may include a proximal end, a distal end, and a longitudinal axis. The helical thread may be disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a first undercut surface and a second undercut surface. The first undercut surface may be angled toward one of the proximal and distal ends of the shaft, and the second undercut surface may be angled toward the other of the proximal and distal ends of the shaft. Can be angled. An integrated attachment arrangement may be disposed at the proximal end of the shaft and configured to be adjustably secured to the spinal stabilization device.

In some embodiments, the integrated attachment arrangement may include a polyaxial head having a first hemispherical surface configured to be polyaxially adjustably secured to the spinal stabilization device.

In some embodiments, the spinal stabilization device includes a first member of the multi-axial head for polyaxially adjustable fixation of a separate tulip to the multi-axial head in any of a variety of relative orientations. A separate tulip may be included having a second hemispherical surface configured to engage the hemispherical surface.

In some embodiments, the separate tulip may include at least one aperture and a locking member configured to secure a rod receivable through the at least one aperture to the separate tulip.

In some embodiments, the integrated attachment arrangement may include an integrated tulip having at least one opening configured to receive at least a portion of the spinal stabilization device therethrough.

In some embodiments, the integrated tulip may further include a locking member configured to secure the rod to the integrated tulip.

In some embodiments, a pedicle fastener stabilization system may include a pedicle fastener, a tulip, and a spinal stabilization rod. A pedicle fastener may include a shaft having a proximal end, a distal end, and a longitudinal axis. The pedicle fastener may also include a polyaxial head at the proximal end of the shaft. The pedicle fastener may also include a first helical screw disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft. The first helical thread may include a first concave undercut surface. The pedicle fastener may also include a second helical screw disposed about the shaft adjacent to the first helical screw. The second helical thread may include a second concave undercut surface. The first concave undercut surface and the second concave undercut surface may be angled toward one of the proximal and distal ends of the shaft. The tulip may be configured to be multi-axis adjustably secured to the multi-axis head, and the spinal stabilization rod may be secured to the tulip.

In some embodiments, the polyaxial head may be integrally formed with the pedicle fastener.

In some embodiments, the multi-axis head may include a first hemispherical surface.

In some embodiments, the tulip engages the first hemispherical surface of the multi-axis head to polyaxially adjustably secure the tulip to the multi-axis head in any of a variety of relative orientations. and a second hemispherical surface configured to.

In some embodiments, the tulip may include at least one opening configured to receive a spinal stabilization rod therethrough.

In some embodiments, the tulip may include a locking member configured to secure the spinal stabilization rod to the tulip.

In some embodiments, the minor diameter of the shaft may be constant.

In some embodiments, a method of implanting a bone fastener assembly includes (1) inserting a bone fastener into the bone; (2) an orientation of the device selected relative to an attachment configuration of the bone fastener. and (3) attaching the instrument to the mounting configuration in the selected orientation. Bone fasteners may include a shaft, a helical screw, and an attachment arrangement. The shaft may include a proximal end, a distal end, and a longitudinal axis. The helical thread may be disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft. The helical thread may include a first undercut surface and a second undercut surface. The first undercut surface may be angled toward one of the proximal and distal ends of the shaft. The second undercut surface may be angled toward the other of the proximal and distal ends of the shaft. The attachment arrangement may be disposed at the proximal end of the shaft and configured to be adjustably secured to the instrument.

In some embodiments, the attachment arrangement at the proximal end of the shaft may be configured to be polyaxially adjustably secured to the instrument. Adjusting the orientation of the instrument to the selected orientation relative to the mounting configuration may include adjusting the orientation of the instrument to the selected relative orientation relative to the mounting configuration among multiple, multiaxially distinct, possible relative orientations. may include multiaxially adjusting the orientation of the instrument to a desired orientation.

In some embodiments, the attachment configuration may include a multi-axis head having a first hemispherical surface, and the instrument engages the first hemispherical surface of the multi-axial head to position the device in any of a variety of relative orientations. and may include a separate tulip having a second hemispherical surface configured to multiaxially adjustably secure the separate tulip to the multiaxial head.

In some embodiments, the separate tulip may include at least one aperture and a locking member configured to secure the rod received through the at least one aperture to the separate tulip.

In some embodiments, the method may also include drilling a pilot hole in the bone and inserting a shaft of the bone fastener into the pilot hole.

In some embodiments, the method also includes tapping a bone screw into the bone to form a female bone screw around the pilot hole, and inserting a helical screw into the female bone screw. may include.

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

Exemplary embodiments of the disclosure will become more fully apparent from the following description, taken in conjunction with the accompanying drawings. With the understanding that these drawings depict only exemplary embodiments and, therefore, should not be considered as limiting the scope of the disclosure, the exemplary embodiments of the disclosure will be understood through the use of the accompanying drawings. It will be described with additional specificity and detail.

1 is a front perspective view of a fastener, according to an embodiment of the present disclosure; FIG. 1B is a rear perspective view of the fastener of FIG. 1A; FIG. 1B is a side view of the fastener of FIG. 1A; FIG. 1C is a side cross-sectional view of the fastener of FIG. 1A taken along line AA shown in FIG. 1C; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 2B is a rear perspective view of the fastener of FIG. 2A; FIG. FIG. 2B is a side view of the fastener of FIG. 2A; 2C is a side cross-sectional view of the fastener of FIG. 2A taken along line BB shown in FIG. 2C; FIG. FIG. 3 is a partial side cross-sectional view of a fastener including a crescent-shaped screw. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 4B is a rear perspective view of the fastener of FIG. 4A. FIG. 4B is a side view of the fastener of FIG. 4A; FIG. 4C is a side cross-sectional view of the fastener of FIG. 4A taken along line DD shown in FIG. 4C; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 5B is a rear perspective view of the fastener of FIG. 5A; FIG. 5B is a side view of the fastener of FIG. 5A; FIG. 5C is a side cross-sectional view of the fastener of FIG. 5A taken along line EE shown in FIG. 5C; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 6B is a rear perspective view of the fastener of FIG. 6A; FIG. 6B is a side view of the fastener of FIG. 6A; FIG. 6C is a side cross-sectional view of the fastener of FIG. 6A taken along line FF shown in FIG. 6C; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 7B is a rear perspective view of the fastener of FIG. 7A; FIG. 7B is a side view of the fastener of FIG. 7A; FIG. 7C is a side cross-sectional view of the fastener of FIG. 7A taken along line GG of FIG. 7C; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 8B is a rear perspective view of the fastener of FIG. 8A; FIG. 1 is an exploded view of a pedicle fastener stabilization system according to an embodiment of the present disclosure; FIG. FIG. 9B shows the pedicle fastener stabilization system of FIG. 9A assembled with a spinal stabilization rod. 9B is a top perspective view of the separate tulip shown in FIG. 9A; FIG. FIG. 3 is a bottom perspective view of a separate tulip. FIG. 3 is a side view of a separate tulip. 9E is a side cross-sectional view of a separate tulip taken along line HH shown in FIG. 9E; FIG. 9B is a top view of a vertebral body with the pedicle fastener stabilization system of FIG. 9A inserted into a pedicle of the vertebral body; FIG. FIG. 10A is a side cross-sectional view of FIG. 10A. 1 is a front perspective view of a threaded stem, according to an embodiment of the present disclosure; FIG. FIG. 11B is a rear perspective view of the threaded stem of FIG. 11A. 11B is a side view of the fastener of FIG. 11A. FIG. 11C is a side cross-sectional view of the fastener of FIG. 11A taken along line II shown in FIG. 11C. FIG. 7 is a front perspective view of a threaded stem according to another embodiment of the present disclosure. FIG. 12B is a rear perspective view of the threaded stem of FIG. 12A. FIG. 12B is a side view of the fastener of FIG. 12A. 12C is a side cross-sectional view of the fastener of FIG. 12A taken along line JJ of FIG. 12C; FIG. FIG. 12B is a side perspective view of the threaded stem of FIG. 12A coupled to an implant. FIG. 12B illustrates a system including the threaded stem of FIG. 12A. FIG. 7 is a front perspective view of a threaded stem according to another embodiment of the present disclosure. FIG. 13B is a rear perspective view of the threaded stem of FIG. 13A. FIG. 13B is a side view of the fastener of FIG. 13A. 13C is a side cross-sectional view of the fastener of FIG. 13A taken along line KK of FIG. 13C; FIG. FIG. 7 is a front perspective view of a threaded stem according to another embodiment of the present disclosure. FIG. 14B is a rear perspective view of the threaded stem of FIG. 14A. FIG. 14B is a side view of the fastener of FIG. 14A. 14C is a side cross-sectional view of the fastener of FIG. 14A taken along line LL of FIG. 14C. FIG. 2 is a front perspective view of a radial head component according to an embodiment of the present disclosure. 14E is a rear perspective view of the radial head component of FIG. 14E; FIG. 14E is a side view of the radial head component of FIG. 14E; FIG. FIG. 14E is a bottom view of the radial head component of FIG. 14E; FIG. 14B shows an assembly including the threaded stem of FIG. 14A and the radial head component of FIG. 14B. FIG. 3 is a rear perspective view of a femoral fastener, according to an embodiment of the present disclosure. FIG. 15B is a front perspective view of the femoral fastener of FIG. 15A; FIG. 15B is a side view of the femoral fastener of FIG. 15A. FIG. 15C is a side cross-sectional view of the fastener shown in FIG. 15C taken along line BB. FIG. 3 is a perspective side view of a femoral support member according to an embodiment of the present disclosure. 16A is another perspective side view of the femoral support member of FIG. 16A. FIG. FIG. 16B is a front view of the femoral support member of FIG. 16A. FIG. 16B is a rear view of the femoral support member of FIG. 16A. FIG. 3 is a front view of a stop member, according to an embodiment of the present disclosure. 17B is a rear perspective view of the stop member of FIG. 17A. FIG. 17B is a front perspective view of the stop member of FIG. 17A; FIG. FIG. 17B is a side view of the stop member of FIG. 17A; FIG. 17B is a side view of the stop member of FIG. 17A with a stop member protrusion. 17B is a side view of the stop member of FIG. 17A with another stop member protrusion; FIG. 1 is an exploded view of a femoral fixation assembly, according to one embodiment of the present disclosure. FIG. 19 is a side view of the femoral fixation assembly of FIG. 18 after being assembled; FIG. FIG. 19 is a side view of the femoral fixation assembly of FIG. 18 implanted in a femur. 21 is a front view of the femoral fixation assembly and femur shown in FIG. 20; FIG. 22 is a side cross-sectional view of the femoral fixation assembly and femur shown in FIG. 21 taken along line CC; FIG. FIG. 3 is a side perspective view of a guide pin inserter assembly adjacent a femur, according to an embodiment of the present disclosure. FIG. 2 is a side cross-sectional view of a guide pin insert, according to one embodiment of the present disclosure. FIG. 3 is a side view of a guide pin inserted into a femur. FIG. 3 is a side view of a guide pin depth gauge adjacent a femur, according to an embodiment of the present disclosure. FIG. 3 is a side view of a tissue shield and reamer adjacent a femur, according to an embodiment of the present disclosure. 1 is a side view of a drill bit, adjustable depth stop, and centering sleeve according to an embodiment of the present disclosure; FIG. FIG. 2 is a side view of a tap device according to an embodiment of the present disclosure. FIG. 3 is an enlarged partial view of a connection configuration between an inserter and a femoral fastener prior to engagement, according to an embodiment of the present disclosure. 30B is a side view of the connection configuration of FIG. 30A after engagement; FIG. FIG. 30B is a side view of the connection configuration of FIG. 30A showing the inserter coupler inside the inserter prior to engaging the female threads of the femoral fastener. 30C is a side view of the connection configuration of FIG. 30C after the inserter coupler has engaged the female threads of the femoral fastener; FIG. FIG. 3 is a side view of a centering sleeve and inserter that facilitates placement of a femoral fastener within a femur. 32 is a side view of the inserter of FIG. 31 utilized to couple a femoral support member to a femoral fastener; FIG. FIG. 4 is a side view of the femoral support member and femoral fastener after the inserter is removed. FIG. 3 is a side view of an impactor and mallet used to seat a femoral support member against a femur. FIG. 3 is a side view of a compression screw inserted into a femoral support member and femoral fastener. 35B is an enlarged view of the compression screw shown in FIG. 35A. FIG. 2 is a side view of a drill bit and drill bit guide forming a bone tunnel in a femur according to an embodiment of the present disclosure; FIG. FIG. 3 is a side view of a depth gauge utilized to measure the depth of a bone tunnel, according to an embodiment of the present disclosure. FIG. 3 is a side view of a driver for installing one or more bone plate fasteners into a femur, according to one embodiment of the present disclosure. FIG. 7 is a side view of a drill bit and drill bit guide forming a bone tunnel in the head of a femur according to another embodiment of the present disclosure. FIG. 3 is a side view of a driver attaching one or more support fasteners to the head of a femur. 41 is a side view of the femoral fixation assembly of FIG. 40 after one or more support fasteners have been installed; FIG. FIG. 3 is a side view of an extension plate coupled to a femoral support member, according to an embodiment of the present disclosure. 43 is a side view of the femoral fixation assembly of FIG. 42 after the extension plate has been coupled to the femoral support member and additional support fasteners have been inserted into the head of the femur; FIG. 42 is a side view of the femoral fixation assembly of FIG. 41 after the trochanteric plate has been coupled to the femoral support member and additional support fasteners have been inserted into the head of the femur, according to another embodiment of the present disclosure. be. The femoral fixation assembly of FIG. 44 shows a drill bit for receiving one or more trochanteric plate fasteners to form one or more bone tunnels for fixing the trochanteric plate to the femur. FIG. FIG. 46 is a side perspective view of the femoral fixation assembly shown in FIG. 45 after one or more trochanteric plate fasteners have been installed. FIG. 46B is a front perspective view of the femoral fixation assembly shown in FIG. 46A. FIG. 7 is a front perspective view of a side plate guide according to another embodiment of the present disclosure. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 48B is a rear perspective view of the fastener of FIG. 48A; FIG. 48B is a side view of the fastener of FIG. 48A; FIG. 48C is a side cross-sectional view of the fastener of FIG. 48A taken along line CC shown in FIG. 48C. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 49B is a rear perspective view of the fastener of FIG. 49A; FIG. 49B is a side view of the fastener of FIG. 49A; FIG. 49C is a side cross-sectional view of the fastener of FIG. 49A taken along line FF of FIG. 49C. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 50B is a rear perspective view of the fastener of FIG. 50A. FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 51B is a rear perspective view of the fastener of FIG. 51A; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 52B is a rear perspective view of the fastener of FIG. 52A; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. 53B is a rear perspective view of the fastener of FIG. 53A; FIG. FIG. 7 is a side perspective view of a fastener, according to another embodiment of the present disclosure. FIG. 54B shows a kit including the fastener of FIG. 54A. FIG. 6 illustrates a side perspective view of a fastener, according to another embodiment of the present disclosure. FIG. 55B shows a kit including the fastener of FIG. 55A. FIG. 7 is a side perspective view of a fastener, according to another embodiment of the present disclosure. FIG. 56B shows a kit including the fastener of FIG. 56A. FIG. 7 is a rear perspective view of a fastener according to another embodiment of the present disclosure. 57B is a rear perspective view of the fastener of FIG. 57A with a separate tool inserted through the cannula of the fastener; FIG. FIG. 7 is a front perspective view of a fastener according to another embodiment of the present disclosure. FIG. 3 is a top perspective view of a fastener engaged with a plate, according to an embodiment of the present disclosure. FIG. 59B is a side perspective view of the fastener and plate of FIG. 59A; FIG. 6 is a perspective view of a fastener engaged with a plate, according to another embodiment of the present disclosure. 60A is a top view of the fastener and plate of FIG. 60A implanted in a tibia; FIG. FIG. 3 is a perspective view of a fastener and plate according to another embodiment of the present disclosure. FIG. 6 is a top perspective view of a plate according to another embodiment of the present disclosure. FIG. 2 is a lateral view of a distal femur fracture. 62B is a side view of the distal femur fracture of FIG. 62B repaired with fasteners and the plate of FIG. 62A; FIG. FIG. 7 is a side view of a fastener, according to another embodiment of the present disclosure. FIG. 3 is a perspective view of a plate according to another embodiment of the present disclosure. FIG. 3 is a perspective view of a plate according to another embodiment of the present disclosure. FIG. 7 is a perspective view of a fastener coupling a plate to a proximal humerus according to another embodiment of the present disclosure. FIG. 64B is a side view of the proximal humerus of FIG. 64A.

It should be understood that the drawings are for the purpose of illustrating the concepts of the disclosure and are not necessarily drawn to scale. Furthermore, the drawings depict exemplary embodiments and do not represent limitations on the scope of the disclosure.
DETAILED DESCRIPTION The exemplary embodiments of the present disclosure are best understood by reference to the drawings, where like parts are indicated by like numerals throughout. It will be readily appreciated that the components of the present disclosure, generally described and illustrated in the drawings, may be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed description of embodiments of implants, systems, and methods illustrated in the drawings is not intended to limit the scope of the disclosure, but merely to illustrate exemplary embodiments of the disclosure. represents.

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

The following disclosure presents various fasteners for use as implantable devices within bone and other tissues (e.g., orthopedic implants, spinal implants, etc.) for the purpose of streamlining the present disclosure. . However, it is understood that the various fastener and helical screw concepts presented herein may be utilized in any medium beyond bone/tissue and/or in any application beyond surgical procedures. will be done.

Example applications/procedures in which any of the fasteners described or discussed herein may be utilized in any configuration and with any of the configurations described herein include spinal procedures (e.g. SI fixation, facet joint fixation, etc.), extremity procedures, reconstructive procedures, trauma procedures, sports-related procedures, bone fixation procedures, bone fusion procedures, arthroplasty procedures, veterinary procedures, procedures involving osteoporosis or damaged bones, etc. may include, but are not limited to.

Additionally, types of fasteners that may utilize any of the screw designs, configurations, and/or features described herein include pedicle fasteners, neck fasteners, threaded stems, threaded intramedullary Includes vascular stems, cortical fasteners, soft tissue fasteners, long fasteners, cannulated fasteners, articular stems, modified fasteners, compression fasteners (such as hip compression fasteners), veterinary fasteners, etc. Not limited to these.

1A-1D illustrate various views of a fastener 100, implantable bone anchor, or bone screw, according to an embodiment of the present disclosure. Specifically, FIG. 1A is a front perspective view of fastener 100, FIG. 1B is a back perspective view of fastener 100, FIG. 1C is a side view of fastener 100, and FIG. 1D is a 1C is a side cross-sectional view of fastener 100 taken along line AA of FIG. 1C. FIG.

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

In some embodiments, the fastener 100 includes a first helical thread 110 disposed about the shaft 105 and a second helical thread disposed about the shaft 105 adjacent to the first helical thread 110. A helical thread 120 may be included.

In some embodiments, fastener 100 may include a "dual start" or "dual lead" thread configuration, including a first helical thread 110 and a second helical thread 120.

In some embodiments, the depth of the first helical thread 110 and/or the second helical thread 120 relative to the shaft 105 may define a large diameter versus a small diameter of the shaft 105 alone.

In some embodiments, the major diameter and/or minor diameter of fastener 100 is constant or substantially constant along the entire length of the fastener or along a majority of the length of the fastener. could be. In these embodiments, a small diameter may help avoid rupturing narrow/delicate bones (eg, pedicles) when inserting the fastener into the bone. In some embodiments, a pilot hole is first drilled into the narrow/delicate bone, and then a fastener having an equivalent small diameter compared to the diameter of the pilot hole is drilled, as detailed below. is selected to avoid rupture when inserting the fastener into the bone.

In some embodiments, the depth of the first helical thread 110 and/or the second helical thread 120 relative to the shaft 105 varies along the length of the shaft 105 such that one or more of the fasteners 100 Multiple major diameters may be defined and/or one or more regions along fastener 100 may include one or more continuously varying major diameters.

In some embodiments, the thickness of shaft 105 may vary along the length of shaft 105 to define one or more minor diameters of fastener 100 and/or may vary along the length of fastener 100. The one or more regions may include one or more continuously variable minor diameters. In some embodiments, the thickness/height/width/length/pitch/shape, etc. of the first helical thread 110 and/or the second helical thread 120 (or any additional helical threads) is similar to that of the shaft. may vary along the length of 105. For example, the thickness/height/width/length/pitch/shape, etc. of the first helical thread 110 and/or the second helical thread 120 may vary either discretely or continuously, It can be larger towards the tip of the fastener and smaller towards the head of the fastener (or vice versa).

In some embodiments, the larger and/or smaller diameters are placed toward the proximal end or head of the fastener to increase compression of the bone when the fastener is ultimately inserted into the bone/tissue. can increase.

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

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

In some embodiments, the plurality of helical threads may include three helical threads (not shown), including a "triple start" or "triple lead" thread configuration (not shown).

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

In some embodiments, the plurality of helical threads may include more than four helical threads (not shown).

In some embodiments, the fastener 100 includes a first member having any of the shapes disclosed herein, oriented toward one of the proximal and distal ends of the fastener 100. , the first screw being disposed proximate the distal end of the fastener 100 and oriented toward the other of the proximal and distal ends of the fastener 100. The fastener 100 may include a second screw having any of the shapes disclosed in the document, the second screw being positioned proximate the head of the fastener 100 (not shown).

In some embodiments, the fastener 100 includes a plurality of fasteners having any of the shapes disclosed herein disposed proximate one of the proximal and distal ends of the fastener 100. (e.g., a double helical thread, etc.) and any of the shapes disclosed herein for a second thread disposed proximate the other of the proximal and distal ends of fastener 100. (not shown).

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

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

In some embodiments, when the fastener 100 is viewed in cross section (see FIG. 1D) along a plane intersecting the longitudinal axis 103 of the shaft 105, the plurality of first concave undercut surfaces 131 and a plurality of second convex undercut surfaces 142 may be directed (ie, directed) toward proximal end 101 of shaft 105 .

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

In some embodiments, the plurality of first concave undercut surfaces 131, the plurality of first convex undercut surfaces 141, the plurality of second concave undercut surfaces 132, and the plurality of second At least one of the convex undercut surfaces 142 may include at least one substantially flat surface.

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 extends toward the distal end 102 of the shaft 105. having a plurality of first intermediate portions 151 oriented (i.e., oriented) (at least one surface angled relative to the longitudinal axis 103 of the shaft 105; and/or at least one The first curved shape may include a plurality of first curved shapes (including an undercut surface). This may be referred to as a "standard" screw having a "standard" orientation.

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 extends toward the proximal end 101 of the shaft 105. (at least one surface angled relative to the longitudinal axis 103 of the shaft 105 and/or at least one under a plurality of second curved shapes (including a cut surface). This may be referred to as a "reverse" thread having a "reverse" direction.

In some embodiments, one or more helical threads may morph/transition between a normal direction and a reverse direction along the shaft of the fastener.

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

As shown in FIG. 1D, the proximally and distally oriented surfaces of the first helical screw 110 (i.e., the first concave undercut surface 131 in the fastener 100 of FIG. 1D) and the first convex undercut surface 141) may not have mirror symmetry with respect to each other across any plane perpendicular to the longitudinal axis 103 of the fastener 100. Rather, first concave undercut surface 131 and first convex undercut surface 141 may be generally parallel to each other. The same may be true for the second helical thread 120, although the second concave undercut surface 132 and the second convex undercut surface 142 may not have mirror symmetry with respect to each other. , may be generally parallel to each other.

Conversely, and as shown in FIG. 1D, the proximally oriented surface of the first helical screw 110 has mirror symmetry with respect to the distally oriented surface of the second helical screw 120. may have. Specifically, a first concave undercut surface 131 bisects the space between them and intersects a plane 170 located perpendicular to the longitudinal axis 103 to form a second convex undercut surface 131 . It may have mirror symmetry with respect to the cut surface 142.

Similarly, the distally oriented surface of the first helical screw 110 may have mirror symmetry with respect to the proximally oriented surface of the second helical screw 120. Specifically, the second concave undercut surface 132 bisects the space between them and intersects a plane 172 located perpendicular to the longitudinal axis 103 to form the first convex undercut surface. It may have mirror symmetry with respect to the cut surface 141.

This mirror symmetry comprises symmetry across different planes located between adjacent turns of the first helical screw 110 and the second helical screw 120 along the length of the longitudinal axis 103. may be present along most of the length of the first helical thread 110 and the second helical thread 120. Such mirror symmetry may help capture bone more effectively between the first helical screw 110 and the second helical screw 120 and may also facilitate manufacturing of the fastener 100. .

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 connects the distal end 102 of the shaft 105 and/or or may include at least one partial crescent shape oriented (ie, directed) toward the proximal end 101 of the shaft 105. FIG. 3 depicts a partial cross-sectional view of a fastener 300 that includes a crescent shape, as a non-limiting example of such an embodiment.

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 is distal to the shaft 105. The second helical thread 120 may include at least one partial crescent shape oriented (i.e., directed) toward the end 102 and the second helical thread 120 directed toward the proximal end 101 of the shaft 105 ( i.e., oriented), may include at least one partial crescent shape.

In some embodiments (not shown), the first helical thread 110 has a first plurality of partial crescent shapes oriented (i.e., directed) toward the distal end 102 of the shaft 105. The second helical thread 120 may include a second plurality of partial crescent shapes oriented (i.e., directed) toward the proximal end 101 of the shaft 105.

In some embodiments (not shown), the first plurality of partial crescent shapes and the second plurality of partial crescent shapes are arranged in alternating succession along the shaft 105 of the fastener 100. can be done.

In some embodiments, the first helical thread 110 may be bisected by line 123 shown in FIG. a cut surface 112, a plurality of third undercut surfaces 113, and a plurality of fourth open surfaces 114 similar to the helical thread shown in FIG. 1D, except with curved surfaces instead of flat surfaces. including.

In some embodiments, the plurality of first undercut surfaces 111 and the plurality of second undercut surfaces 112 may include concave curved surfaces. However, portions of the plurality of first undercut surfaces 111 and/or portions of the plurality of second undercut surfaces 112 may include convex curved surfaces and/or flat surfaces (not shown in FIG. 3). will be understood.

In some embodiments, the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may include convex curved surfaces. However, it will be appreciated that some of the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 may include concave curved surfaces and/or flat surfaces (not shown in FIG. 3). Dew.

In some embodiments, the plurality of third undercut surfaces 113 and the plurality of fourth open surfaces 114 are replaced with sloped surfaces (such as those utilized in standard buttress screw designs) without any undercuts. (not shown in Figure 3). Similarly, any of the other thread designs disclosed herein may utilize a beveled or buttress thread design on at least one side of the helical thread.

In some embodiments, fasteners may have only standard threads or only reverse threads. The type of thread desired may depend on the type and/or magnitude of the load being applied to the fastener. For example, a screw that is axially loaded away from the bone in which it is implanted may advantageously have a standard thread, whereas a screw that is axially loaded towards the bone in which it is implanted. may advantageously have reverse threads. Screws capable of experiencing multiaxial loading and/or offloading conditions advantageously have at least one It may include one standard screw and at least one reverse screw to reduce high bone strains and distribute multiaxial forces applied to the bone in a load-sharing configuration rather than a load-bearing configuration. Shear loads and/or bending moments are determined by the threads, thread configurations, and/or thread deformations contemplated herein to optimally resist shear loads, bending moments, multiaxial loads, off-road conditions, etc. can be optimally resisted with any selected combination of .

In some embodiments, standard threaded fasteners may be used in combination with reverse threaded fasteners to accommodate different loading patterns.

In some embodiments, a single thread fastener, such as fastener 100, may have both regular threads and reverse threads. Such thread combinations may help fastener 100 remain in place despite unknown and/or changing loading patterns.

In some embodiments, the shape of the threads of a fastener (with standard and/or reverse threads) may be modified to fit the fastener for a particular loading scheme. For example, the number of threads, the number of thread starts, the pitch of the thread, the lead of the thread, the shape of the thread, any dimensions associated with the thread (e.g., any length/width/height associated with the thread), Large diameter, small diameter, angulation/angle associated with any surface of the screw, "handedness" of the screw (e.g., right-handed vs. left-handed), etc. may be involved, installation, loading pattern, required radial load, pull-out Strength, application, treatment, etc. may be modified to suit the particular medium.

In some embodiments, the materials of any portion of the fasteners described herein include metals (e.g., titanium, cobalt, stainless steel, etc.), metal alloys, plastics, polymers, PEEK, UHMWPE, composites. , additive particles, textured surfaces, organisms, biomaterials, bones, etc., but are not limited to.

In some embodiments, any of the fasteners described herein may include a self-tapping configuration, a locking configuration (e.g., formed on a portion of the fastener, such as a screw located on or near the head of the fastener). additional configurations such as cannulation, any style of fastener head (or no fastener head at all), any style of torque connection interface (or no torque connection interface at all) may be included.

In some embodiments, a tap (not shown) may be utilized to preform a screw in bone according to any of the screw shapes disclosed or discussed herein. Thus, a tap having any suitable shape may be used with any fastener described or discussed herein to match or substantially match the threaded shape of a given fastener.

In some embodiments, the small diameter of the fastener is smaller than the lower diameter formed in the bone to avoid rupturing the bone when the fastener is inserted into the pilot hole, as described in more detail below. It may be selected to match or substantially match the diameter of the hole.

Additionally or alternatively, the type of screw and/or the shape of the screw may be varied based on the type of bone to which the fastener is secured. For example, fasteners secured to osteoporotic bone may be fixed using standard or reverse threads, or when the pitch, major diameter, and/or minor diameter is increased or decreased, or when the angle of the thread face is increased or decreased. It may work better when the formation is adjusted.

In some embodiments, a surgical kit may include multiple fasteners having any of the different fastener and thread options described or discussed herein. The surgeon may select the appropriate fastener from the kit based on the particular load being applied and/or the quality of the bone to which the fastener will be secured.

Continuing with FIG. 1D, in some embodiments, the first helical thread 110 has 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.

In some embodiments, the second helical thread 120 includes a plurality of fifth undercut surfaces 125, a plurality of sixth undercut surfaces 126, a plurality of seventh undercut surfaces 127, and a plurality of seventh undercut surfaces 127. 8 open surfaces 128.

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

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 are formed on the shaft 105. may be angled toward the distal end 102 of.

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.

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 FIG. 1D), the first helical thread 110 is It can include at least one chevron shape oriented (ie, directed) toward the distal end 102 of the shaft 105 . Similarly, second helical thread 120 may also include at least one chevron shape oriented (i.e., directed) toward proximal end 101 of shaft 105.

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 FIG. 1D), the first helical thread 110 is The first plurality of chevron shapes may be oriented (ie, directed) toward the distal end 102 of the shaft 105 . Similarly, second helical thread 120 may include a second plurality of chevron shapes oriented (i.e., directed) toward proximal end 101 of shaft 105.

In some embodiments, the first plurality of chevron shapes and the second plurality of chevron shapes may be arranged in alternating succession along the shaft 105 of the fastener 100 (see, e.g., FIG. ID) .

In some embodiments, the plurality of first coupling spaces 161 and the plurality of second coupling spaces 162 connect the first helical threads 110 and the second helical threads 120 along the shaft 105 of the fastener 100. can be formed between.

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

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

In some embodiments, the plurality of first coupling spaces 161 may be larger in size than the plurality of second coupling spaces.

In some embodiments, the plurality of first bonding spaces 161 and the plurality of second bonding spaces 162 may be shaped and/or configured to bond with bone/other tissue received therein; Enhances the fixation of the fastener 100 within the bone/other tissue and provides additional resistance to multiaxial forces that may be applied to the fastener 100 and/or the bone/other tissue.

In some embodiments, the plurality of second undercut surfaces 112 and the plurality of sixth undercut surfaces 126 may be angled toward each other to accommodate bone/other matter within the plurality of first connection spaces 161. tissue to increase fixation and resistance to multiaxial forces.

In some embodiments, the plurality of third undercut surfaces 113 and the plurality of seventh undercut surfaces 127 may be angled toward each other to accommodate bone/other matter within the plurality of second connection spaces 162. tissue to increase fixation and resistance to multiaxial forces.

In some embodiments, the plurality of first undercut surfaces 111 and the plurality of fifth undercut surfaces 125 are each at an angle α with respect to the longitudinal axis 103 of the shaft 105, as shown in FIG. 1D. can be formed.

In some embodiments, angle α may be greater than 90 degrees.

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

In some embodiments, angle β may be less than 90 degrees.

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.

In some embodiments, angle θ may be about 90 degrees.

In some embodiments, angle θ may be greater than 90 degrees.

It is understood that fastener 100 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. There will be. Furthermore, it will also be understood that fastener 100 may be utilized with (or within) any system, method, or device described or discussed herein.

2A-2D show various views of a polyaxial screw, pedicle fastener, or fastener 200 according to another embodiment of the present disclosure. Specifically, FIG. 2A is a front perspective view of fastener 200, FIG. 2B is a back perspective view of fastener 200, FIG. 2C is a side view of fastener 200, and FIG. 2D is a 2C is a side cross-sectional view of fastener 200 taken along line BB of FIG. 2C. FIG. Fastener 200 may include a shaft 205 having a proximal end 201, a distal end 202, and a longitudinal axis 203. Fastener 200 also includes a multi-axis head 204 having a first hemispherical surface 221 disposed at the proximal end 201 of shaft 205, a torque connection interface 206 formed in/on multi-axis head 204, and shaft 205. may include a self-tapping configuration 207 formed at the distal end 202 of the . In some embodiments, the fastener 200 includes a first helical thread 210 disposed about the shaft 205 and a second helical thread 210 disposed about the shaft 205 adjacent to the first helical thread 210. Helical thread 220 may be included. In these embodiments, fastener 200 may include a "dual start" or "dual lead" thread configuration. However, fastener 200 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. Furthermore, it will also be understood that fastener 200 may be utilized with (or within) any system, method, or device described or discussed herein.

4A-4D show various views of a polyaxial screw, pedicle fastener, or fastener 400 according to another embodiment of the present disclosure. Specifically, FIG. 4A is a front perspective view of fastener 400, FIG. 4B is a back perspective view of fastener 400, FIG. 4C is a side view of fastener 400, and FIG. 4D is a 4C is a side cross-sectional view of fastener 400 taken along line DD of FIG. 4C. FIG. Fastener 400 may include a shaft 405 having a proximal end 401, a distal end 402, and a longitudinal axis 403. The fastener 400 also includes a multi-axis head 404 having a first hemispherical surface 421 disposed at the proximal end 401 of the shaft 405, a torque connection interface 406 formed in/on the multi-axis head 404, and A self-tapping formation 407 formed on the distal end 402 of the shaft 405 may be included. In some embodiments, fastener 400 may include a single helical thread 410 disposed about shaft 405, as shown in FIG. 4D. In some embodiments, fastener 400 may include a "single start" or "single lead" thread configuration with a standard orientation, as shown in FIG. 4D. However, fastener 400 may also include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. That will be understood. Furthermore, it will also be understood that fastener 400 may be utilized with (or within) any system, method, or device described or discussed herein.

5A-5D show various views of a polyaxial screw, pedicle fastener, or fastener 500 according to another embodiment of the present disclosure. Specifically, FIG. 5A is a front perspective view of fastener 500, FIG. 5B is a back perspective view of fastener 500, FIG. 5C is a side view of fastener 500, and FIG. 5D is a 5C is a side cross-sectional view of fastener 500 taken along line EE of FIG. 5C. FIG. Fastener 500 may include a shaft 505 having a proximal end 501, a distal end 502, and a longitudinal axis 503. The fastener 500 also includes a polyaxial head 504 having a first hemispherical surface 521 disposed at the proximal end 501 of the shaft 505, a torque connection interface 506 formed in/on the polyaxial head 504, and a shaft. 505 may include a self-tapping configuration 507 formed at the distal end 502 of 505 . In some embodiments, fastener 500 may include a single helical thread 510 disposed about shaft 505, as shown in FIG. 5D. In some embodiments, the fastener 500 may include a "single start" or "single lead" thread configuration with a reverse orientation, as shown in FIG. 5D. However, it is understood that fastener 500 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. It will also be understood. Additionally, it will also be understood that fastener 500 may be utilized with (or within) any system, method, or device described or discussed herein.

6A-6D show various views of a polyaxial screw, pedicle fastener, or fastener 600 according to another embodiment of the present disclosure. Specifically, FIG. 6A is a front perspective view of fastener 600, FIG. 6B is a back perspective view of fastener 600, FIG. 6C is a side view of fastener 600, and FIG. 6D is a 6C is a side cross-sectional view of fastener 600 taken along line FF of FIG. 6C. FIG. Fastener 600 may include a shaft 605 having a proximal end 601, a distal end 602, and a longitudinal axis 603. The fastener 600 also includes a multi-axis head 604 having a first hemispherical surface 621 disposed at the proximal end 601 of the shaft 605, a torque connection interface 606 formed in/on the multi-axis head 604, and Shaft 605 may include a self-tapping formation 607 formed at distal end 602. In some embodiments, the fastener 600 includes a first helical thread 610 disposed about the shaft 605 and a second helical thread disposed about the shaft 605 adjacent to the first helical thread 610. A screw 620 may be included. In these embodiments, fastener 600 may include a "dual start" or "dual lead" thread configuration. In some embodiments, the dual-start screw configuration may require less rotation of the fastener 600 during insertion, allowing for faster insertion of the fastener 600 into bone/other tissue. . In some embodiments, first helical thread 610 and second helical thread 620 may each include a "standard" thread having a "standard" orientation, as shown in FIG. 6D. However, fastener 600 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. Additionally, it will also be understood that fastener 600 may be utilized with (or within) any system, method, or device described or discussed herein.

7A-7D show various views of a polyaxial screw, pedicle fastener, or fastener 700 according to another embodiment of the present disclosure. Specifically, FIG. 7A is a front perspective view of fastener 700, FIG. 7B is a back perspective view of fastener 700, FIG. 7C is a side view of fastener 700, and FIG. 7D is 7C is a side cross-sectional view of fastener 700 taken along line GG in FIG. 7C. FIG. Fastener 700 may include a shaft 705 having a proximal end 701, a distal end 702, and a longitudinal axis 703. The fastener 700 also includes a multi-axis head 704 having a first hemispherical surface 721 disposed at the proximal end 701 of the shaft 705, a torque connection interface 706 formed in/on the multi-axis head 704, and , may include a self-tapping configuration 707 formed on the distal end 702 of the shaft 705. In some embodiments, the fastener 700 includes a first helical thread 710 disposed about the shaft 705 and a second helical thread disposed about the shaft 705 adjacent to the first helical thread 710. A screw 720 may be included. In these embodiments, fastener 700 may include a "dual start" or "dual lead" thread configuration. This double thread configuration may allow for faster insertion of fastener 700 into bone/tissue by requiring less rotation of fastener 700 during insertion. In some embodiments, the first helical thread 710 and the second helical thread 720 may each include "reverse" threads having "opposite" orientations, as shown in FIG. 7D. However, fastener 700 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , it will be understood. Furthermore, it will also be understood that fastener 700 may be utilized with (or within) any system, method, or device described or discussed herein.

8A and 8B show various views of a pedicle fastener or fastener 800, according to another embodiment of the present disclosure. Specifically, FIG. 8A is a front perspective view of fastener 800, and FIG. 8B is a back perspective view of fastener 800.

Fastener 800 may generally include a shaft 805 having a proximal end 801, a distal end 802, a helical thread 810, and a self-tapping configuration 807. Fastener 800 also includes an integrated attachment arrangement, such as an integrated tulip 840, disposed at the proximal end 801 of shaft 805, and a torque connection interface 806 within integrated tulip 840. obtain.

In some embodiments, at least a portion of the small diameter and/or large diameter of the shaft 805 of the helical screw 810 prevents bone rupture during bone fastener insertion, as described in more detail below. Can be constant to help prevent.

Fastener 800 may also include a helical thread 810 disposed about shaft 805. In some embodiments, helical thread 810 may include a standard thread. In some embodiments, helical thread 810 may include reverse threads. However, fastener 800 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , it will be understood. For example, in some embodiments, helical thread 810 may include a first helical thread having regular or reverse threads that includes a first concave undercut surface, and fastener 800 includes: Also, a second helical thread (non-standard) having a standard or reverse thread including a second concave undercut surface adjacent to the first helical thread, forming a "dual start" thread configuration. (as shown). Furthermore, it will also be understood that fastener 800 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, integrated tulip 840 may include at least one aperture 843 formed through one or more sides of integrated tulip 840.

In some embodiments, integrated tulip 840 may include two openings formed through opposing sides of integrated tulip 840.

In some embodiments, at least one aperture 843 may be configured to receive at least a portion of a spinal stabilization device therethrough.

In some embodiments, the spinal stabilization device may include a spinal stabilization rod or rods (see, eg, rod 930 shown in FIG. 9B).

In some embodiments, integrated tulip 840 may be configured to adjustably secure at least a portion of a spinal stabilization device to integrated tulip 840 through at least one aperture 843.

In some embodiments, integrated tulip 840 includes a locking member aperture 855 configured to receive a locking member (see, e.g., locking member 950 shown in FIG. 9A) therein. obtain.

In some embodiments, the locking member may be configured to secure at least a portion of a spinal stabilization rod received through at least one aperture 843 of integrated tulip 840.

9A-9F illustrate various views of a pedicle fastener stabilization system, according to one embodiment of the present disclosure. Specifically, FIG. 9A shows an exploded view of the pedicle fastener stabilization system, and FIG. 9B shows the pedicle fastener stabilization system of FIG. 9A assembled together (including the spinal stabilization rod). 9C shows a top perspective view of a separate tulip or tulip 940 of the pedicle fastener stabilization system shown in FIG. 9A, FIG. 9D shows a bottom perspective view of the tulip 940, and FIG. 9E shows a side view of tulip 940, and FIG. 9F shows a side cross-sectional view of tulip 940 taken along line HH shown in FIG. 9E.

As shown in FIG. 9A, the pedicle fastener stabilization system may generally include a pedicle fastener or fastener 900, a tulip 940, and a locking member 950. In some embodiments, the pedicle fastener stabilization system may also include a spinal stabilization rod or rod 930, which may be securable to the tulip 940 (see FIG. 9B).

Fastener 900 may generally include a shaft 905 having a proximal end 901, a distal end 902, and a longitudinal axis 903. Fastener 900 may also include a helical thread 910 disposed about shaft 905 along longitudinal axis 903 between proximal end 901 and distal end 902 of shaft 905. Fastener 900 may also include an integrated attachment arrangement, such as a multi-axis head 904 having a first hemispherical surface 921 located at the proximal end 901 of shaft 905. Fastener 900 may further include a torque connection interface 906 formed in/on multi-axis head 904 and a self-tapping arrangement 907 formed at distal end 902 of shaft 905.

In some embodiments, helical thread 910 may include a standard thread. In some embodiments, helical thread 910 may include reverse threads. However, fastener 900 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , it will be understood. For example, in some embodiments, helical thread 910 may include a first helical thread having regular or reverse threads that includes a first concave undercut surface, and fastener 900 includes: Also, a second helical thread (non-standard) having a standard or reverse thread including a second concave undercut surface adjacent to the first helical thread, forming a "dual start" thread configuration. (as shown). Furthermore, it will also be understood that fastener 900 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, the polyaxial head 904 at the proximal end of the shaft 905 may be configured to be polyaxially adjustably secured to a spinal stabilization device.

In some embodiments, the spinal stabilization device may include a tulip 940.

In some embodiments, the tulip 940 can include a second hemispherical surface 922 that can be configured to engage the first hemispherical surface 921 of the multi-axis head 904, positioning the tulip 940 in various relative orientations. It is fixed to the multi-axis head 904 so as to be multi-axially adjustable.

In some embodiments, tulip 940 may include at least one aperture 943 formed through one or more sides of tulip 940.

In some embodiments, tulip 940 may include two openings formed through opposing sides of tulip 940.

In some embodiments, at least one aperture 943 may be configured to receive a spinal stabilization rod or at least a portion of rod 930 therethrough, as shown in FIG. 9B.

In some embodiments, tulip 940 may also include a locking member aperture 955 configured to receive locking member 950 therein.

In some embodiments, tulip 940 locks at least a portion of rod 930 by tightening locking member 950 to compress rod 930 between tulip 940 and locking member 950, as shown in FIG. 9B. can be configured to adjustably secure the tulip 940 to the tulip 940.

Fastener 900 may incorporate any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within the vertebrae or any other bone/tissue. may be included. Furthermore, it will also be understood that fastener 900 may be utilized with (or within) any system, method, or device described or discussed herein.

10A shows a top view of vertebral body 980 with the pedicle fastener stabilization system of FIG. 9A inserted into pedicle 982 of vertebral body 980, and FIG. 10B shows a top view of vertebral body 980 of FIG. A side sectional view is shown.

In some embodiments, a polyaxial bone fastener assembly (such as the pedicle fastener stabilization system shown in FIGS. 9A-10B or the bone fastener assembly shown in FIGS. 12A-12F) The method of implantation generally includes the steps of: (1) inserting a bone fastener into the bone; (2) adjusting the orientation of the device to a selected orientation relative to the mounting configuration of the bone fastener; and (3) the steps of: to the mounting arrangement in the selected orientation.

In some embodiments, a bone fastener may include a shaft, a helical screw, and an attachment arrangement.

In some embodiments, the shaft is disposed about the shaft along a proximal end, a distal end, a longitudinal axis, and a longitudinal axis between the proximal and distal ends of the shaft. may include a helical thread.

In some embodiments, at least a portion of the small diameter and/or large diameter of the shaft/helical screw is configured to prevent bone rupture during bone fastener insertion, as described in more detail below. Can be usefully constant.

In some embodiments, the helical thread may include a first undercut surface and a second undercut surface.

In some embodiments, the first undercut surface may be angled toward one of the proximal and distal ends of the shaft, and the second undercut surface may be angled toward one of the proximal and distal ends of the shaft. It can be angled towards the other end. However, the bone fastener may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. It will be understood. For example, in some embodiments, the bone fastener includes a first helical screw with a standard or reversed thread, as well as a first helical screw adjacent to the first helical screw, such as in a "dual start" screw configuration. , a second helical thread with a standard or reverse thread.

In some embodiments, the attachment arrangement may be disposed at the proximal end of the shaft and configured to be adjustably secured to the instrument.

In some embodiments, the attachment arrangement may be configured to be polyaxially adjustably secured to the instrument.

In some embodiments, the attachment arrangement may be coupled to a bone fastener or a shaft of a bone fastener.

In some embodiments, adjusting the orientation of the instrument to the selected orientation relative to the mounting configuration includes adjusting the orientation of the instrument to the selected orientation relative to the mounting configuration in a plurality of potentially polyaxially distinct relative orientations. The method may include multi-axially adjusting the orientation of the instrument to the selected relative orientation.

In some embodiments, the attachment arrangement may be integrally formed with the bone fastener or the shaft of the bone fastener.

In some embodiments, the attachment arrangement can include a multi-axis head having a first hemispherical surface, and the instrument has a second hemispherical surface configured to engage the first hemispherical surface of the multi-axial head. The tulip may include a separate tulip having a surface, and the separate tulip may be polyaxially adjustably secured to the multi-axis head in any of a variety of relative orientations. For example, the second hemisphere of a separate tulip is selected (out of a plurality of possible polyaxially distinct relative orientations) with respect to the first hemisphere of a multiaxial head. The individual tulips can then be attached to the multi-axis head in selected relative orientations.

In some embodiments, the separate tulip is configured to secure the at least one aperture and the rod received through the at least one aperture to the separate tulip in a selected relative orientation. A locking member.

In some embodiments, the mounting arrangement can include a multi-axis head having a first hemispherical surface, and the instrument has a second hemispherical surface configured to engage the first hemispherical surface. The radial head component may include a radial head component that enables multi-axis articulation of the radial head component relative to the multi-axis head that allows multi-axis articulation, as described in more detail below with respect to FIGS. 12A-12F. . However, in some embodiments, the mounting arrangement may include a head that may be rigidly coupled with a radial head component, as described in more detail below with respect to FIGS. 14A-14I.

In some embodiments, the method may also include drilling a pilot hole (not shown) in the bone and inserting a shaft of the bone fastener into the pilot hole.

In some embodiments, the method also includes tapping one or more bone screws into the bone (not shown) to form one or more female bone screws around the pilot hole; The method may include inserting a helical screw into one or more female bone screws.

Bone rupture can occur when a bone fastener is inserted into a bone and generates sufficient outward radial force on the bone, depending on the size/shape of the bone fastener and/or the bone fastener. The size/configuration of the bone hole that receives the tool causes bone rupture.

In some embodiments, a method for preventing bone rupture generally includes forming a hole in a bone (not shown), the hole having a bone hole diameter, and having a diameter less than or equal to 5% smaller than the bone hole diameter. The method may include inserting a bone fastener into the hole. In this way, the outward radial force exerted on the bone by the small diameter of the fastener may be reduced and rupture of the bone may be prevented.

In some embodiments, the shaft has a proximal end, a distal end, and at least one shaft disposed about the shaft along a longitudinal axis between the proximal and distal ends of the shaft. It may include a longitudinal axis having a helical thread.

In some embodiments, at least a portion of the reduced diameter of the shaft may be constant to help prevent bone rupture during insertion of the bone fastener. For example, the main portion of the bone fastener may exclude a sharp tip portion of the bone fastener (see, e.g., as a non-limiting example, main portion 986 and sharp tip portion 984 of fastener 900 in FIG. 10B). ). Additionally, in some embodiments, the main portion of the bone fastener may exclude a proximal portion of the bone fastener, which may or may not be fully inserted into the bone (e.g., non-limiting As an example, see proximal portion 988 of fastener 900 in FIG. 10B). Thus, in some embodiments, the minor diameter of the main portion of the bone fastener may be constant (e.g., as a non-limiting example, see constant minor diameter 960 of the main portion of fastener 900 in FIG. 10B). ).

In some embodiments, at least a portion of the major diameter of the fastener may be constant during insertion to help prevent bone rupture by the screws of the bone fastener (e.g., one non-limiting example (see the major diameter 965 of the main portion of the fastener 900 in FIG. 10B, which is constant as shown in FIG. 10B).

In some embodiments, the helical thread may include a first undercut surface and a second undercut surface.

In some embodiments, the first undercut surface may be angled toward one of the proximal and distal ends of the shaft, and the second undercut surface may be angled toward one of the proximal and distal ends of the shaft. It can be angled towards the other end. However, the bone fastener may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , it will be understood. For example, in some embodiments, the bone fastener includes a first helical screw with a standard or reversed thread, as well as a first helical screw adjacent to the first helical screw, such as in a "dual start" screw configuration. , a second helical thread with a standard or reverse thread.

In some embodiments, the minor diameter of at least the main portion of the shaft can be greater than the diameter of the bone hole. For example, the minor diameter of at least a major portion of the shaft may be greater than the diameter of the bone hole, but not greater than 5% of the diameter of the bone hole.

In some embodiments, the minor diameter of at least the main portion of the shaft may be no greater than the diameter of the bone hole.

In some embodiments, the minor diameter of at least the main portion of the shaft can be equal to the diameter of the bone hole.

In some embodiments, the minor diameter of at least the main portion of the shaft can be less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be between 0 mm and 0.1 mm and less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be at least 0.1 mm less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft may be between 0.1 mm and 0.2 mm, less than the diameter of the bone hole.

In some embodiments, the minor diameter of the main portion of the shaft can be at least 0.2 mm less than the diameter of the bone hole.

However, it will be appreciated that at least a portion of the minor diameter of the shaft may be of any size less than, equal to, or greater than the diameter of the bone hole.

In these embodiments, the unique form of the screw design disclosed herein "over-drills" a given bone hole to create a bone hole that is equal to or larger than the minor diameter of at least a major portion of the shaft. diameter while maintaining good bone capture and loading characteristics provided by the unique configuration of the screw design disclosed herein. Thus, an over-drilled bone hole is placed in the bone due to the smaller diameter of the shaft to prevent bone rupture, in combination with the smaller diameter and unique configuration of the screw design disclosed herein. lower radially outward loading forces can be achieved. This is in contrast to typical procedures that rely on "under-drilling" the bone hole and compressing the bone with small-diameter fasteners that are larger than the diameter of the bone hole to achieve sufficient bone capture. It is. However, this results in a greater radially outward loading force being placed on the bone due to the larger minor diameter of the shaft, increasing the risk of bone rupture.

In some embodiments, the method also includes tapping one or more bone screws into the bone to form one or more female bone screws around the hole in the bone. (not shown) and then inserting the helical screw into one or more female bone screws and applying an outward radial force to the bone by the helical screw as the bone fastener is inserted into the bone. may further include the step of further reducing.

11A-11D show various views of a threaded stem, bone fastener, or fastener 1100 according to another embodiment of the present disclosure. Specifically, FIG. 11A is a front perspective view of fastener 1100, FIG. 11B is a back perspective view of fastener 1100, FIG. 11C is a side view of fastener 1100, and FIG. 11D is 11C is a side cross-sectional view of fastener 1100 taken along line II shown in FIG. 11C.

Fastener 1100 generally includes a proximal end 1101, a distal end 1102, a longitudinal axis 1103, a helical thread 1110 disposed about shaft 1105 along longitudinal axis 1103, a head 1104, and / may include a shaft 1105 having a torque connection interface 1106 formed thereon.

In some embodiments, the fastener 1100 may include a helical thread 1110 disposed about the shaft 1105 with a "single start" or "single lead" thread configuration, having regular or reverse threads. .

In some embodiments, helical thread 1110 may include a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface.

In some embodiments, the first undercut surface and the third undercut surface may be angled toward one of the proximal end 1101 and distal end 1102 of the shaft 1105, and the second undercut surface The surface and the fourth open surface may be angled toward the other of the proximal end 1101 and distal end 1102 of the shaft 1105.

However, fastener 1100 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. It will be understood. For example, in some embodiments, the helical thread 1110 may include a first helical thread having regular or reverse threads, and the fastener 1100 may also include, adjacent to the first helical thread: A second helical screw (not shown) having standard or reverse threads may be included to form a "dual start" thread configuration or the like. Additionally, it will also be understood that fastener 1100 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, at least a portion of fastener 1100 may be sized, shaped, and configured for use within an intramedullary canal (IMC) of a bone. For example, in some embodiments, fastener 1100 is sized and shaped for use within an IMC, such as as a transfemoral stem (or transfemoral stem abutment), humeral stem, tibial stem, etc. and can be configured. However, fastener 1100 may be sized for use within any IMC of bone and/or for any other suitable treatment or application outside of the IMC of bone. It will also be understood that , can be shaped and configured.

In some embodiments, fastener 1100 may include a minor diameter 1160 and a major diameter 1165, as shown in FIG. 11D.

In some embodiments, the ratio of large diameter 1165 to small diameter 1160 may be less than 1.50.

In some embodiments, the ratio of large diameter 1165 to small diameter 1160 may be less than 1.25.

In some embodiments, the ratio of large diameter 1165 to small diameter 1160 may be less than 1.10.

In some embodiments, the ratio of large diameter 1165 to small diameter 1160 may be less than 1.05.

In some embodiments, at least a portion of the reduced diameter 1160 of the shaft 1105 may be constant during insertion of the fastener 1100 to help prevent bone rupture.

In some embodiments, at least a portion of the large diameter 1165 of the shaft 1105 may be constant during insertion of the fastener 1100 to help prevent bone rupture.

12A-12F show various views of a threaded stem, bone fastener, or fastener 1200 according to another embodiment of the present disclosure. Specifically, FIG. 12A is a front perspective view of fastener 1200, FIG. 12B is a back perspective view of fastener 1200, FIG. 12C is a side view of fastener 1200, and FIG. 12D is 12C is a side cross-sectional view of fastener 1200 taken along line J-J shown in FIG. 12C; FIG. 12E is a side perspective view of fastener 1200 coupled to radial head component 1220; 12F shows a system/kit 1250 that includes fastener 1200.

Fastener 1200 generally includes a proximal end 1201, a distal end 1202, a longitudinal axis 1203, a helical thread 1210, a polyaxial head 1204, a torque connection interface 1206 formed in/on the polyaxial head 1204, and a A shaft 1205 can be included with one or more self-tapping configurations 1207.

In some embodiments, the fastener 1200 includes a helical thread 1210 disposed about the shaft 1205 in a "single start" or "single lead" thread configuration having a standard or reverse orientation. obtain.

In some embodiments, helical thread 1210 may include a first undercut surface and a second undercut surface.

In some embodiments, the first undercut surface may be angled toward one of the proximal end 1201 and distal end 1202 of the shaft 1205, and the second undercut surface may be angled toward one of the proximal end 1201 and the distal end 1202 of the shaft 1205. The proximal end 1201 and the distal end 1202 may be angled toward the other.

In some embodiments, helical thread 1210 may include a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface.

In some embodiments, the first undercut surface and the third undercut surface can be angled toward one of the proximal end 1201 and distal end 1202 of the shaft 1205, and the second undercut surface The surface and the fourth open surface may be angled toward the other of the proximal end 1201 and distal end 1202 of the shaft 1205.

However, fastener 1200 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. It will be understood. For example, in some embodiments, the helical thread 1210 may include a first helical thread having a standard or reverse thread, and the fastener 1200 may also include a standard helical thread adjacent to the first helical thread. A second helical thread (not shown) may be included, such as with a "dual-start" thread configuration, having opposite or opposite threads. Furthermore, it will also be understood that fastener 1200 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, at least a portion of fastener 1200 may be sized, shaped, and configured for use within an IMC of bone. For example, in some embodiments, fastener 1200 may be sized, shaped, and configured for use within a radial IMC, such as as a threaded radial stem. However, fastener 1200 may be sized and shaped for use within any IMC of any bone and/or for any other suitable treatment or application outside of the IMC of bone. It will also be understood that it can be assumed and configured.

In some embodiments, fastener 1200 may include a minor diameter 1260 and a major diameter 1265, as shown in FIG. 12D.

In some embodiments, the ratio of large diameter 1265 to small diameter 1260 can be less than 1.50.

In some embodiments, the ratio of large diameter 1265 to small diameter 1260 may be less than 1.25.

In some embodiments, the ratio of large diameter 1265 to small diameter 1260 can be less than 1.10.

In some embodiments, the ratio of large diameter 1265 to small diameter 1260 may be less than 1.05.

In some embodiments, at least a portion of the reduced diameter 1260 of the shaft 1205 may be constant during insertion of the fastener 1200 to help prevent bone rupture.

In some embodiments, at least a portion of the large diameter 1265 of the shaft 1205 may be constant during insertion of the fastener 1200 to help prevent bone rupture.

In some embodiments, an attachment arrangement may be disposed at the proximal end 1201 of the shaft 1205 and configured to be adjustably secured to an instrument, such as a radial head component 1220 or a joint component (not shown). obtain.

In some embodiments, the attachment arrangement can include a multi-axis head 1204 that can be coupled to or integrally formed with the proximal end 1201 of the shaft 1205.

In some embodiments, multi-axis head 1204 may include a first hemispherical surface 1221.

In some embodiments, a radial head component 1220 (or a glenoid component, etc.) may be coupled to the polyaxial head 1204 of the fastener 1200 for use in radial head arthroplasty procedures, glenoid procedures, and the like.

In some embodiments, the radial head component 1220 is configured to engage the first hemispherical surface 1221 to enable polyaxial articulation of the radial head component 1220 to the polyaxial head 1204. A second hemisphere 1222 may be included.

In some embodiments, radial head component 1220 may include a concave articular surface 1224 configured to receive a convex articular surface (not shown) to form a joint prosthesis.

In some embodiments, the system/kit 1250 may include one or more drill bits 1230 of various sizes to form pilot holes of various sizes in a radius (not shown). The system/kit 1250 also includes one or more fasteners 1200 of various sizes, one or more radial head components 1220 of various sizes, and a method for coupling the radial head components 1220 to the fasteners 1200. One or more couplers 1240, etc. may be included.

13A-13D show various views of a threaded stem, bone fastener, or fastener 1300 according to another embodiment of the present disclosure. Specifically, FIG. 13A is a front perspective view of fastener 1300, FIG. 13B is a back perspective view of fastener 1300, FIG. 13C is a side view of fastener 1300, and FIG. 13D is 13C is a side cross-sectional view of fastener 1300 taken along line KK shown in FIG. 13C.

The fastener 1300 generally includes a proximal end 1301, a distal end 1302, a longitudinal axis 1303, a helical thread 1310 disposed about a shaft 1305 along the longitudinal axis 1303, a head 1304, and a It can include a shaft 1305 having a torque connection interface 1306 formed thereon.

In some embodiments, the fastener 1300 includes a helical thread 1310 disposed about the shaft 1305 in a "single start" or "single lead" thread configuration with standard threads or reverse threads. may be included.

In some embodiments, helical thread 1310 may include a first undercut surface and a second undercut surface.

In some embodiments, the first undercut surface may be angled toward one of the proximal end 1301 and distal end 1302 of the shaft 1305, and the second undercut surface may be angled toward one of the proximal end 1301 and the distal end 1302 of the shaft 1305. The proximal end 1301 and the distal end 1302 may be angled toward the other.

In some embodiments, helical thread 1310 may include a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface.

In some embodiments, the first undercut surface and the third undercut surface may be angled toward one of the proximal end 1301 and distal end 1302 of the shaft 1305, and the second undercut surface The surface and the fourth open surface may be angled toward the other of the proximal end 1301 and distal end 1302 of the shaft 1305.

However, fastener 1300 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , it will be understood. For example, in some embodiments, the helical thread 1310 may include a first helical thread having regular or reverse threads, and the fastener 1300 may also include, adjacent to the first helical thread, A second helical thread (not shown) may be included with standard or reverse threads, forming a "dual start" thread configuration or the like. Furthermore, it will also be understood that fastener 1300 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, at least a portion of fastener 1300 may be sized, shaped, and configured for use within an intramedullary canal (IMC) of a bone. For example, in some embodiments, fastener 1300 is sized and shaped for use within an IMC as a transfemoral stem (or transfemoral stem abutment), humeral stem, tibial stem, etc. and can be configured. However, fastener 1300 may be sized, shaped and shaped for use within any IMC of any bone and/or for any other suitable treatment or application outside of the IMC of bone. It will also be understood that it can be configured and configured.

In some embodiments, fastener 1300 may include a pinhole 1391 formed through shaft 305 of fastener 1300. Pinhole 1391 may be configured to receive anti-rotation pin 1390 therethrough. In this manner, anti-rotation pin 1390 may prevent rotation and/or loosening of fastener 1300 once fastener 1300 is implanted within bone.

In some embodiments, fastener 1300 may be utilized in limb salvage procedures to prevent amputation and/or reduce the need for further amputation.

In some embodiments, fastener 1300 may include an attachment arrangement 1395 that may be configured to removably couple with an instrument such as a prosthetic component (not shown). For example, fastener 1300 may be inserted into an intramedullary canal of a long bone (eg, femur, humerus, etc.). Once the fastener 1300 achieves sufficient osteointegration within a long bone, another prosthetic component, such as an abutment (not shown), can be removably coupled to the fastener 1300 via the attachment arrangement 1395 and the patient and connects, by way of non-limiting example, with a prosthetic limb (eg, a prosthetic hand, leg, prosthetic foot, etc., not shown).

In some embodiments, fastener 1300 may include a minor diameter 1360 and a major diameter 1365, as shown in FIG. 13D.

In some embodiments, the ratio of large diameter 1365 to small diameter 1360 can be less than 1.50.

In some embodiments, the ratio of large diameter 1365 to small diameter 1360 may be less than 1.25.

In some embodiments, the ratio of large diameter 1365 to small diameter 1360 can be less than 1.10.

In some embodiments, the ratio of large diameter 1365 to small diameter 1360 can be less than 1.05.

In some embodiments, at least a portion of the reduced diameter 1360 of the shaft 1305 may be constant during insertion of the fastener 1300 to help prevent bone rupture.

In some embodiments, at least a portion of the large diameter 1365 of the shaft 1305 may be constant during insertion of the fastener 1300 to help prevent bone rupture.

14A-14F show various views of a threaded stem, bone fastener, or fastener 1400 according to another embodiment of the present disclosure. Specifically, FIG. 14A is a front perspective view of fastener 1400, FIG. 14B is a back perspective view of fastener 1400, FIG. 14C is a side view of fastener 1400, and FIG. 14D is 14C is a side cross-sectional view of fastener 1400 taken along line LL shown in FIG. 14C. 14E is a front perspective view of a radial head component 1420 that may be utilized with fastener 1400, FIG. 14F is a back perspective view of radial head component 1420, and FIG. 14G is a side view of radial head component 1420. 14H is a bottom view of radial head component 1420 and FIG. 14I is a side view of an assembly including radial head component 1420 and fastener 1400.

Fastener 1400 generally has a proximal end 1401, a distal end 1402, a longitudinal axis 1403, a helical thread 1410, an attachment arrangement or head 1404, and a torque connection interface 1406 formed in/on the head 1404. A shaft 1405 may be included.

In some embodiments, the fastener 1400 includes a helical thread 1410 disposed about the shaft 1405 in a "single start" or "single lead" thread configuration having a standard or reverse orientation. may be included.

In some embodiments, helical thread 1410 may include a first undercut surface and a second undercut surface.

In some embodiments, the first undercut surface may be angled toward one of the proximal end 1401 and distal end 1402 of the shaft 1405, and the second undercut surface may be angled toward one of the proximal end 1401 and the distal end 1402 of the shaft 1405. It can be angled toward the other of the proximal end 1401 and distal end 1402.

In some embodiments, helical thread 1410 may include a first undercut surface, a second undercut surface, a third undercut surface, and a fourth open surface.

In some embodiments, the first undercut surface and the third undercut surface can be angled toward one of the proximal end 1401 and distal end 1402 of the shaft 1405, and the second undercut surface The surface and the fourth open surface may be angled toward the other of the proximal end 1401 and distal end 1402 of the shaft 1405.

However, fastener 1400 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. It will be understood. For example, in some embodiments, the helical thread 1410 may include a first helical thread having regular or reverse threads, and the fastener 1400 may also include a first helical thread adjacent to the first helical thread. , a second helical screw (not shown) having standard or reverse threads, forming a "dual start" screw configuration, or the like. Furthermore, it will also be understood that fastener 1400 may be utilized with (or within) any system, method, or device described or discussed herein.

In some embodiments, at least a portion of fastener 1400 may be sized, shaped, and configured for use within an IMC of bone. For example, in some embodiments, fastener 1400 may be sized, shaped, and configured for use within a radial IMC, such as a threaded radial stem. However, fastener 1400 may be sized, shaped and configured for use within any IMC of any bone and/or for any other suitable treatment or application outside of the IMC of bone. It will also be understood that it can be configured and configured.

In some embodiments, fastener 1400 may include a minor diameter 1460 and a major diameter 1465, as shown in FIG. 14D.

In some embodiments, the ratio of large diameter 1465 to small diameter 1460 can be less than 1.50.

In some embodiments, the ratio of large diameter 1465 to small diameter 1460 can be less than 1.25.

In some embodiments, the ratio of large diameter 1465 to small diameter 1460 can be less than 1.10.

In some embodiments, the ratio of large diameter 1465 to small diameter 1460 can be less than 1.05.

In some embodiments, at least a portion of the reduced diameter 1460 of the shaft 1405 may be constant during insertion of the fastener 1400 to help prevent bone rupture.

In some embodiments, at least a portion of the large diameter 1465 of the shaft 1405 may be constant during insertion of the fastener 1400 to help prevent bone rupture.

In some embodiments, an attachment arrangement or head 1404 is disposed on the proximal end 1401 of the shaft 1405 and is adapted to be adjustably secured to an instrument such as a radial head component 1420 or a glenoid component (not shown). can be configured.

In some embodiments, head 1404 may be coupled to or integrally formed with proximal end 1401 of shaft 1405.

In some embodiments, the head 1404 can include a neck portion 1412 and a protruding portion 1414.

In some embodiments, protruding portion 1414 may include a disk shape.

In some embodiments, protruding portion 1414 may also include one or more beveled surfaces 1416.

In some embodiments, the radial head component 1420 (or glenoid component, etc.) is attached to the fastener 1400 for use in a radial head arthroplasty procedure, an arthroplasty procedure, etc., as shown in FIG. 14I. can be coupled to the head 1404 of.

In some embodiments, radial head component 1420 can include a concave articular surface 1424 that can be configured to receive a convex articular surface (not shown) to form a joint prosthesis.

In some embodiments, radial head component 1420 may include a mounting arrangement 1430.

In some embodiments, the attachment arrangement 1430 includes a window that may be sized and shaped to receive the head 1404 and neck portion 1412 of the fastener 1400 therein, as shown in FIG. 14I. 1432.

In some embodiments, the mounting arrangement 1430 is also configured to accept one or more set screws (not shown) to removably couple the radial head component 1420 to the fastener 1400. , one or more set screw holes 1436.

15A-15D show various views of a femoral fixation device or fastener 4300, according to another example of the present disclosure. Specifically, FIG. 15A is a rear perspective view of femoral fastener 4300, FIG. 15B is a front perspective view of femoral fastener 4300, and FIG. 15C is a side view of femoral fastener 4300. 15D is a side cross-sectional view of femoral fastener 4300 taken along line BB in FIG. 15C.

In general, the femoral fastener 4300 can include a shaft 4305 having a proximal end 4301, a distal end 4302, and a longitudinal axis 4303, as well as a helical thread 4310 disposed about at least a portion of the shaft 4305. .

In some embodiments, the shaft 4305 of the femoral fastener 4300 may be cannulated with a through hole 4390.

In some embodiments, the through-hole 4390 can include internal threads 4380 formed along at least a portion of the length of the through-hole 4390.

In some embodiments, internal threads 4380 may be positioned toward proximal end 4301 of shaft 4305.

In some embodiments, the proximal end 4301 of the femoral fastener 4300 may include a headless fastener design having an at least partially cylindrical shape.

In some embodiments, the proximal end 4301 of the femoral fastener 4300 may extend along the shaft from the proximal end 4301 of the shaft 4305 toward the distal end 4302 of the shaft 4305. may include a recess 4370 .

In some embodiments, the one or more recesses 4370 are inserted into the insertion tool to form a torque connection interface that may facilitate insertion of the femoral fastener 4300, as described in more detail below. may be formed and configured to couple with.

In some embodiments, femoral fastener 4300 may include one or more self-tapping or osteotomizing configurations formed in a distal portion of femoral fastener 4300 (not shown).

In some embodiments, helical thread 4310 may be disposed about shaft 4305 along longitudinal axis 4303 between a first position 4321 and a second position 4322 along shaft 4305.

Although the femoral fastener 4300 shown in FIGS. 15A-15D depicts a single helical screw design, the femoral fastener 4300 may include any number of screws and/or any number of screws described or discussed herein. It will be appreciated that any number of thread features, shapes or configurations may be included in any combination. For example, the femoral fastener 4300 may include a "dual start" or "dual lead" thread configuration, including a first helical thread, a second helical thread, and the like, as previously described herein.

In some embodiments, the depth of the helical thread 4310 relative to the shaft 4305 may define a large diameter versus a small diameter for the shaft 4305 alone.

In some embodiments, the major diameter, minor diameter, and/or pitch of helical thread 4310 may be constant or substantially constant along the length of femoral fastener 4300.

In some embodiments, helical thread 4310 may include one or more concave undercut surfaces 4331 and/or one or more convex undercut surfaces 4341.

In some embodiments, one or more concave undercut surfaces 4331 may be angled toward one of proximal end 4301 and distal end 4302 of shaft 4305.

In some embodiments, one or more convex undercut surfaces 4341 may be angled toward the other of proximal end 4301 and distal end 4302 of shaft 4305.

In some embodiments, the one or more concave undercut surfaces 4331 may be angled toward the proximal end 4301 of the shaft 4305 and the one or more convex undercut surfaces 4341 may be angled toward the proximal end 4301 of the shaft 4305. Shaft 4305 may be angled toward distal end 4302.

In some embodiments, the one or more concave undercut surfaces 4331 and/or the one or more convex undercut surfaces 4341 include a plurality of flat surfaces that are angled with respect to each other. may be included.

In some embodiments, helical thread 4310 may include one or more first undercut surfaces 4311 and one or more second undercut surfaces 4312.

In some embodiments, the one or more first undercut surfaces 4311 may be angled toward the proximal end 4301 of the shaft 4305 and the one or more second undercut surfaces 4312 may be angled toward the proximal end 4301 of the shaft 4305. , may be angled toward the distal end 4302 of the shaft 4305.

In some embodiments, helical thread 4310 may also include one or more third undercut surfaces 4313 and one or more fourth open surfaces 4314. However, in other embodiments, the one or more third undercut surfaces 4313 and the one or more fourth open surfaces 4314 may have any desired shape without departing from the spirit or scope of this disclosure. A surface or surfaces of other shapes (e.g., any serrated thread shape, angled toward or away from one or more concave undercut surfaces 4331, or or any curved surface oriented generally toward or away from one or more concave undercut surfaces). You will understand what you get.

In some embodiments, when the femoral fastener 4300 is viewed in cross-section along a plane intersecting the longitudinal axis 4303 of the shaft 4305, the helical thread 4310 extends toward the proximal end 4301 of the shaft 4305. It may include at least one oriented chevron shape.

In some embodiments, when the femoral fastener 4300 is viewed in cross-section along a plane intersecting the longitudinal axis 4303 of the shaft 4305, the helical thread 4310 extends toward the proximal end 4301 of the shaft 4305. It may include a plurality of oriented chevron shapes.

In some embodiments, when the femoral fastener 4300 is viewed in cross-section along a plane that intersects the longitudinal axis 4303 of the shaft 4305, the helical thread 4310 is attached to the proximal end 4301 or the distal end of the shaft 4305. It can include at least one partial crescent shape oriented toward end 4302.

In some embodiments, when the femoral fastener 4300 is viewed in cross-section along a plane that intersects the longitudinal axis 4303 of the shaft 4305, the helical thread 4310 is attached to the proximal end 4301 or the distal end of the shaft 4305. It can include a plurality of partial crescent shapes oriented toward end 4302.

In some embodiments, when the femoral fastener 4300 is implanted within the neck 4710 and head 4720 of the femoral bone or femur 4700, the first location 4321, the second location 4322, and the A helical screw 4310 extending therebetween may be placed within the head 4720 of the femur 4700.

In some embodiments, when the femoral fastener 4300 is implanted within the neck 4710 and head 4720 of the femur 4700, one or more concave undercut surfaces 4331, one or more convex undercut surface 4341, one or more first undercut surfaces 4311, one or more second undercut surfaces 4312, one or more third undercut surfaces 4313, and/or one or at least one of the plurality of fourth open surfaces 4314 is configured to transmit at least one force from the head 4720 of the femur 4700 to the neck 4710 (or other portion) of the femur 4700. can be done. As such, the unique shape and configuration of the helical screw 4310 reduces or reduces the loosening of the femoral fastener 4300 over time due to multi-axial forces and off-axis loading scenarios that may be applied to the femoral fastener 4300. It can help prevent.

In some embodiments, one or more coupling spaces 4361 may be formed along the shaft 4305 of the femoral fastener 4300 between adjacent threaded portions of the helical screw 4310.

In some embodiments, the one or more bonding spaces 4361 may be shaped and/or configured to bond with the bone/other tissue received therein. femoral fastener 4300 and provides additional resistance to multi-axial forces that may be applied to femoral fastener 4300 and/or bone/other tissue.

In some embodiments, when the femoral fastener 4300 is viewed in cross-section along a plane that intersects the longitudinal axis 4303 of the shaft 4305, the helical screw 4310 is located at the proximal end 4301 and the distal end of the shaft 4305. one or more bent shapes (relative to longitudinal axis 4303 of shaft 4305) with one or more intermediate portions 4351 oriented (i.e., directed) toward one of ends 4302 and/or at least one undercut surface).

In some embodiments, one or more concave undercut surfaces 4331, one or more convex undercut surfaces 4341, one or more first undercut surfaces 4311, one or more At least one of the second undercut surface 4312, the one or more third undercut surfaces 4313, and/or the one or more fourth open surfaces 4314 has at least one substantially May include flat surfaces.

In some embodiments, one or more concave undercut surfaces 4331, one or more convex undercut surfaces 4341, one or more first undercut surfaces 4311, one or more At least one of the second undercut surface 4312, one or more third undercut surfaces 4313, and/or one or more fourth open surfaces 4314 includes at least one curved surface. obtain.

16A-16D illustrate various views of a femoral support member 4400, according to an example of the present disclosure. Specifically, FIG. 16A is a side perspective view of femoral support member 4400, FIG. 16B is another side perspective view of femoral support member 4400, and FIG. 16C is a front view of femoral support member 4400. FIG. 16D is a rear view of femoral support member 4400.

Generally, femoral support member 4400 can include an elongate body having a proximal end 4401, a distal end 4402, a longitudinal axis 4403, and a barrel 4405.

In some embodiments, femoral support member 4400 can include a bone plate.

In some embodiments, femoral support member 4400 may include an intramedullary nail (not shown).

In some embodiments, the femoral support member 4400 includes one or more bone plate apertures 4434, one or more lower support apertures 4432, one or more upper support apertures 4431, and/or one or may include a plurality of extension plate apertures 4436.

In some embodiments, the barrel 4405 can include a passageway 4410 formed therethrough having a first opening 4411 and a second opening 4412 opposite the first opening 4411.

In some embodiments, the passageway 4410 may also include an internal thread 4414 and a barrel shoulder 4416 positioned adjacent the internal thread 4414.

In some embodiments, the barrel 4405 and/or passageway 4410 have a longitudinal axis 4408 at an angle 4409 with respect to the longitudinal axis 4403 of the femoral support member 4400, as shown in FIG. It can be formed through the support member 4400.

In some embodiments, the angle 4409 of the barrel 4405 and/or passageway 4410 with respect to the longitudinal axis 4403 of the femoral support member 4400 can be acute. However, it will also be appreciated that in some embodiments angle 4409 can be a right angle and/or an obtuse angle.

17A-17F show various views of a stop member 4500, according to an example of the present disclosure. Specifically, FIG. 17A is a front view of stop member 4500, FIG. 17B is a rear perspective view of stop member 4500, FIG. 17C is a front perspective view of stop member 4500, and FIG. 17D is 17E and 17F are side views of a stop member 4500 including a stop member projection 4510 having a preselected length 4505.

Generally, stop member 4500 can include a proximal end 4501, a distal end 4502, and a longitudinal axis 4503.

In some embodiments, stop member 4500 may include a torque connection interface 4530. In some embodiments, torque connection interface 4530 may include a hexagonal shape. However, it will be appreciated that the torque connection interface 4530 may include any shape suitable for receiving torque force from a driver tool, as described in more detail below.

In some embodiments, stop member 4500 may include external threads 4525.

In some embodiments, the stop member 4500 may include a stop member shoulder intermediate the external threads 4525 and the stop member projection 4510.

In some embodiments, the preselected length 4505 of the stop member projection 4510 may be zero.

In some embodiments, the preselected length 4505 of the stop member projection 4510 can be greater than zero.

In some embodiments, the preselected length 4505 of the stop member protrusion 4510 is 3 mm, 5 mm, 10 mm, etc., as some non-limiting examples of preselected lengths 4505 greater than zero. It can be. However, it will be appreciated that a length greater than or equal to zero may be utilized as the preselected length 4505 of the stop member projection 4510.

18-22 show various views of a femoral fixation assembly 4600 that includes a femoral support member 4400, a femoral fastener 4300, and a stop member 4500, according to an embodiment of the present disclosure. Specifically, FIG. 18 shows an exploded view of the femoral fixation assembly 4600, FIG. 19 shows a side view of the femoral fixation assembly 4600 after assembly, and FIG. 21 shows a front view of the femoral fixation assembly 4600 and femur 4700 of FIG. 20, and FIG. 22 shows a front view of the femoral fixation assembly 4600 and femur 4700 of FIG. A side cross-sectional view of a femoral fixation assembly 4600 and a femur 4700 is shown.

Referring to FIG. 22, when the femoral fastener 4300 is implanted within the neck 4710 and head 4720 of the femur 4700 and the femoral support member 4400 is oriented relative to the longitudinal axis of the femur, the femoral fastener 4300 At least a portion of the shaft 4305 of the tool 4300 may be slidably received within the passageway 4410 of the barrel 4405 through a first opening 4411 of the passageway 4410.

In this manner, the femoral fastener 4300 is inserted into the passageway 4410 of the barrel 4405 as the femur 4700 collapses due to the bone remodeling process, the healing process, continued use of the femur over time, etc. Furthermore, it may be allowed to slide.

However, it may be desirable to limit the amount of collapse that the femur 4700 can undergo. Accordingly, in some embodiments, stop member 4500 may be inserted into passageway 4410 to set a predetermined limit on the amount of collapse that femur 4700 may be allowed to undergo.

In some embodiments, at least a portion of the stop member 4500 may be received within the passageway 4410 through the second opening 4412.

In some embodiments, stop member 4500 can be inserted into passageway 4410 and coupled thereto by engaging external threads 4525 of stop member 4500 with internal threads 4380 of femoral fastener 4300.

In some embodiments, stop member shoulder 4520 of stop member 4500 may be configured to abut barrel shoulder 4416 of passageway 4410 when stop member 4500 is fully inserted into passageway 4410.

In some embodiments, based on the preselected length 4505 of the stop member projection 4510, a space 4610 having a predetermined length 4605 is located between the distal end 4502 of the stop member 4500 and the proximal end of the shaft 4305. A passageway 4410 may be formed between the end 4301 and the end 4301 . The predetermined length 4605 of the space 4610 may be allowed to be received by the femur 4700.
The amount of collapse may be defined.

In some embodiments, the preselected length 4505 of the stop member projection 4510 may be selected such that the predetermined length 4605 of the space 4610 within the passageway 4410 may be zero. In these embodiments, the distal end 4502 of the stop member 4500 may abut the proximal end 4301 of the femoral fastener 4300 to prevent collapse.

In some embodiments, the preselected length 4505 of the stop member projection 4510 may be selected such that the predetermined length 4605 of the space 4610 within the passageway 4410 may be greater than zero. In these embodiments, the predetermined length 4605 of the space 4610 within the passageway 4410 may define the amount of collapse that the femur 4700 may be allowed to undergo.

23-47 show various views of surgical procedures that may be utilized to install femoral fixation assembly 4600 within femur 4700.

FIG. 23 shows a side perspective view of a guide pin inserter assembly 4800 positioned adjacent a femur 4700, according to an embodiment of the present disclosure.

Guide pin inserter assembly 4800 may generally include a handle 4850, a side plate positioner 4810 coupled to handle 4850, a side plate guide 4820 coupled to side plate positioner 4810, and a guide pin insert 4840 coupled to side plate guide 4820. .

In some embodiments, one or more of the handle 4850, side plate positioner 4810, side plate guide 4820, and/or guide pin insert 4840 may each be removably connectable to each other.

In some embodiments, one or more of the handle 4850, side plate positioner 4810, side plate guide 4820, and/or guide pin insert 4840 may be integrally formed with each other. For example, in some embodiments, side plate positioner 4810 and side plate guide 4820 may be integrally formed with each other.

Side plate guide 4820 may be positioned laterally of femur 4700 by manipulating handle 4850 to orient side plate guide 4820 relative to the longitudinal axis of the femur. Once the side plate guide 4820 is properly positioned adjacent the lateral side of the femur 4700, one or more locating pins 4830 are inserted through the opening 4827 formed in the side plate guide 4820 to attach the side plate guide 4820 to the femur. It can be fixed at 4700.

Once the side plate guide 4820 is secured to the femur 4700 at the desired location, the guide pin insert 4840 directs the distal end of the guide pin insert 4840 to the desired superior/inferior location and/or path of the guide pin 4730. Accordingly, it may be coupled to the side plate guide 4820 by inserting into one of the locating slots 4825 of the side plate guide 4820.

In some embodiments, the interior space 4845 of the guide pin insert 4840 is substantially straight and/or straight to guide the guide pin 4730 along a single path into the head 4720 of the femur 4700. or may be cylindrical in shape.

In some embodiments, the interior space 4845 of the guide pin insert 4840 is configured to allow the surgeon some degree of freedom in selecting the path of the guide pin 4730 to the head 4720 of the femur 4700. , flared, and/or slightly conical.

In some embodiments, the interior space 4845 of the guide pin insert 4840 can include an angle 4846 that allows the path of the guide pin 4730 to be varied at least in the anterior-posterior direction.

In some embodiments, angle 4846 can be about 9 degrees, as a non-limiting example. However, it will be appreciated that interior space 4845 may include any angle.

In some embodiments, once the guide pin 4730 is properly positioned within the head 4720 of the femur 4700, the guide pin inserter assembly 4800 inserts the guide pin 4730 by sliding the side plate guide 4820 upwardly. It can be removed from the femur without disturbance. In these embodiments, the guide pin insert 4840 can be removed from the guide pin 4730 and the side plate guide 4820 is then moved upwardly so that the guide pin 4730 is removed from the removal slot 4826 formed in the side plate guide 4820. and downwardly exit the side plate guide 4820. In these embodiments, the removal slot 4826 is configured to provide a channel through which the guide pin 4730 can exit the side plate guide 4820 downwardly as the side plate guide 4820 is moved upwardly (as shown in FIG. 23). can extend further upwards than For example, FIG. 47 shows a side plate guide 4820 with a removal slot 4826 extending upwardly to connect with one or more locating slots 4825. In this manner, guide pin 4730 may be allowed to exit side plate guide 4820 downwardly through removal slot 4826 as side plate guide 4820 is moved upwardly.

FIG. 25 shows a side view of guide pin 4730 positioned within femur 4700 after guide pin inserter assembly 4800 is removed.

FIG. 26 shows a side view of a guide pin depth gauge 4900 adjacent the femur 4700 to measure the depth of the guide pin 4730 within the femur 4700. Guide pin depth gauge 4900 may include one or more indicia 4910 configured to indicate the depth of guide pin 4730 within femur 4700, which then indicates the depth of guide pin 4730 within femoral fastener 4300. can be utilized to determine the selected length for.

Once the depth of the guide pin 4730 is determined, the reamer 41100 and tissue are used to drill a bone tunnel within the femur 4700, which may be configured to receive the barrel 4405 of the femoral support member 4400 therein. A shield 41000 may be placed adjacent the femur 4700.

In some embodiments, the distal end 41010 of the tissue shield 41000 can be notched to fit laterally to the femur 4700.

In some embodiments, the reamer 41100 may include a flared portion 41110 therein that may be configured to provide a countersink in the femur for receiving the base 4440 of the barrel 4405 (FIG. 16D) ).

FIG. 28 shows a side view of a drill bit 41300, adjustable depth stop 41200, and centering sleeve 41400, according to an embodiment of the present disclosure. Adjustable depth stop 41200 is drilled onto drill bit 41300 while pressing button 41210 of adjustable depth stop 41200 until the previously measured femoral fastener length is seen in window 41205. Can be slid. Button 41210 can then be released to couple adjustable depth stop 41200 to drill bit 41300 and hold it in position. Centering sleeve 41400 can be slid over drill bit 41300. Drill bit 41300 and centering sleeve 41400 may then be placed on guide pin 4730. Centering sleeve 41400 may be slid along guide pin 4730 until seated, and drill bit 41300 may then be rotated to form a bone tunnel for femoral fastener 4300. Drill bit 41300 may be advanced until adjustable depth stop 41200 abuts centering sleeve 41400. This may indicate that the bone tunnel has been formed to the appropriate depth, corresponding to the depth shown in window 41205 of adjustable depth stop 41200.

FIG. 29 shows a side view of a tap 41500, according to an embodiment of the present disclosure. Adjustable depth stop 41200 may be placed on tap 41500 in the same manner as drill bit 41300 described above. Tap 41500 and centering sleeve 41400 can then be placed over guide pin 4730 and advanced into the femur. Tap 41500 may then be rotated using handle 4850 to form a female bone screw around a bone tunnel in head 4720 of femur 4700. The female bone screw may be configured to receive the helical thread 4310 of the femoral fastener 4300 therein.

In some embodiments, tap 41500 may be configured to preform a thread in femur 4700 according to any thread shape disclosed herein. Thus, a tap having any suitable shape may be used with any fastener described or discussed herein to match or substantially match the threaded shape of a given fastener. .

30A-30D illustrate a connection configuration formed between an inserter tool 41600 and a femoral fastener 4300, according to one embodiment of the present disclosure. Specifically, FIG. 30A is an enlarged partial view of the connection configuration between inserter tool 41600 and femoral fastener 4300 before engagement, and FIG. 30B is an enlarged partial view of the connection configuration of FIG. 30A after engagement. 30C is a side view of the connection configuration showing the inserter coupler 41620 within the inserter tool 41600 before engaging the female threads 4380 of the femoral fastener 4300, and FIG. , depicts a side view of the connection configuration after external threads 41630 of inserter coupler 41620 engage internal threads 4380 of femoral fastener 4300 to retain femoral fastener 4300 to inserter tool 41600. As shown in FIGS. 30A-30B, inserter tool 41600 can include one or more projections 41610 that can be received within one or more recesses 4370 of femoral fastener 4300. In this manner, femoral fastener 4300 may be coupled with inserter tool 41600 to facilitate insertion of femoral fastener 4300 into a bone tunnel formed in femur 4700.

FIG. 31 shows a side view of centering sleeve 41400 and inserter tool 41600 that facilitates placement of femoral fastener 4300 within femur 4700.

In some embodiments, a portion of the shaft 4305 of the femoral fastener 4300 that includes the helical thread 4310 may be positioned within the head 4720 of the femur 4700 such that the concave undercut surface of the helical thread 4310 can be placed on the head 4720 of the femur 4700 to transmit at least one force from the head 4720 of the femur 4700 to the neck 4710 of the femur 4700.

In some embodiments, placing a portion of the shaft 4305 that includes a helical screw 4310 within the head 4720 of the femur 4700 includes attaching the helical screw 4310 to a female bone screw placed around a bone tunnel. including rotating shaft 4305 to insert the .

FIG. 32 shows an inserter tool that facilitates placement of the femoral support member 4400 relative to the femur 4700 with the proximal end 4301 of the shaft 4305 of the femoral fastener 4300 positioned within the passageway 4410 of the barrel 4405. 41600 is shown in a side view.

Thus, in some embodiments, the proximal end 4301 of the shaft 4305 of the femoral fastener 4300 connects the femoral support member 4400 when the femoral support member 4400 is oriented relative to the longitudinal axis of the femur. It can be inserted into a first opening 4411 of a passageway 4410 formed therethrough.

Additionally, in some embodiments, the distal end 4502 of the stop member 4500 may be inserted into a second opening 4412 of the passageway 4410, opposite the first opening 4411, such that it has a predetermined length. A space 4610 is formed in the passageway 4410 between the distal end 4502 of the stop member 4500 and the proximal end 4301 of the shaft 4305 based on the preselected length 4505 of the stop member 4500 or the stop member protrusion 4510. obtain. In some embodiments, a stop member 4500 may be placed within the passageway 4410 after the femoral support member 4400 is secured to the femur 4700 (see, eg, FIGS. 38-46B).

FIG. 33 shows a side view of femoral support member 4400, femoral fastener 4300, and femur 4700 after inserter tool 41600 is removed.

FIG. 34 shows a side view of an impactor 41700 and mallet 41800 that may be utilized to further seat the femoral support member 4400 against the femur 4700 in some embodiments.

FIG. 35A shows a side view of a compression screw 41900 being inserted into a femoral support member 4400 and a femoral fastener 4300 using a driver tool 42000, according to an embodiment of the present disclosure. FIG. 35B shows an enlarged view of the compression screw 41900 shown in FIG. 35A. If desired, the compression screw 41900 can be used to create a compressive force across the fracture of the femur 4700 by threading the compression screw 41900 into the femoral fastener 4300 while The head presses against the barrel shoulder 4416 within the passageway 4410. Compression screw 41900 can be rotated until the desired compression force is achieved. One or more support fasteners 42800 (see, e.g., FIG. 41) are then placed across the fracture while the compression screw 41900 generates the compressive force to maintain the compressive force. obtain. The compression screw 41900 may then be removed after compression is achieved and maintained by the one or more support fasteners 42800. However, in some embodiments, compression screw 41900 may remain within femoral fixation assembly 4600.

36-41 illustrate the installation of various bone screws to secure the femoral fixation assembly 4600 to the femur 4700. Specifically, FIG. 36 shows a side view of a drill bit 42100 and drill bit guide 42200 forming one or more bone tunnels in a femur 4700, and FIG. 37 shows the required length for a bone screw. FIG. 38 shows a side view of a depth gauge 42300 measuring the depth of a bone tunnel to confirm the depth of the bone tunnel, and FIG. 39 shows a side view of the drill bit 42600 and drill bit guide 42700 forming a bone tunnel into the head 4720 of the femur 4700, and FIG. 41 shows a side view of the femoral fixation assembly 4600 after the one or more support fasteners 42800 are installed. .

FIG. 42 shows a side view of an extension plate 42900 coupled to a femoral support member 4400 using a driver tool 43000, according to some embodiments of the present disclosure. FIG. 43 shows a side view of the femoral fixation assembly 4600 after the extension plate 42900 has been coupled to the femoral support member 4400 and the support fastener 42800 has been inserted through the extension plate 42900 and into the head 4720 of the femur 4700. Show the diagram.

44-46B illustrate installation of a trochanteric plate 43100 on a femur 4700 according to some embodiments of the present disclosure. Specifically, FIG. 44 shows the femoral bone 4700 after the trochanteric plate 43100 has been coupled to the femoral support member 4400 and the additional support fasteners 42800 have been inserted through the trochanteric plate 43100 and into the head 4720 of the femur 4700. 45 shows a side view of a femoral fixation assembly 4600 of FIG. 46A shows a side view of a femoral fixation assembly 4600 having a drill bit 43300 forming one or more bone tunnels within the trochanteric plate 43100. 46B shows a front view of the femoral fixation assembly 4600 of FIG. 46A after being installed into the femur 4700 through the femoral fixation assembly 4600.

This disclosure provides, for purposes of streamlining this disclosure, implantable devices (e.g., orthopedic implants, spinal implants, sports medicine implants, dental implants, trauma implants, reconstructive implants, extremity implants, cranio-maxillofacial (CMF) implants, A variety of fasteners are presented for use within bone and other tissues, such as veterinary implants. However, it is understood that the various fastener and helical screw concepts presented herein can be utilized in any medium beyond bone/tissue and/or in any application beyond surgical procedures. It will be understood.

Exemplary applications/procedures in which any of the fasteners described or discussed herein may be utilized in any configuration and with any of the configurations described herein include trauma procedures, spinal procedures (e.g., SI fixation, facet joint fixation), reconstructive procedures, sports-related procedures, ACL/tenodes procedures, extremity procedures, dental procedures, CMF procedures, veterinary procedures, fracture fixation plate procedures (e.g., distal femoral plates) , proximal humerus plate, tibial plate, etc.), supplementary fixation for IBD treatment, intramedullary canal fixation procedure, nail fixation procedure, limb salvage and transfemoral procedure, amputee connection procedure, complete shoulder fixation, reverse glenoid fixation, Ossicular fixation (e.g., podiatry, hand/wrist, etc.), joint fixation, single tooth implant fixation, jaw/facial reconstruction, denture fixation, veterinary trauma, species-specific procedures (e.g., horse, dog, rabbit, etc.), TPLO , shear fixation, osteotomy, fusion, procedures involving osteoporosis or damaged bone, and the like.

Additionally, types of fasteners that may utilize any of the screw designs, configurations, and/or features described herein include cortical fasteners, soft tissue fasteners, elongated fasteners, cannulated fasteners, etc. Fasteners, plate fasteners, locking/non-locking fasteners, dynamic hip fasteners, acetabular cup fasteners, Schanz pins, half pins, pedicle fasteners, neck fasteners, threaded stems, threaded intramedullary canal stems, joints Stems, modified fasteners, compression fasteners (e.g. headless/headed compression fasteners, hip compression fasteners, etc.), ACL fasteners, tendon fixation fasteners, bone-tendon-bone implant fasteners, suture anchors, These include, but are not limited to, dental fasteners, mandibular tenting fasteners, veterinary fasteners, and the like.

48A-48D show various views of a headless screw or fastener 5300, according to another embodiment of the present disclosure. Specifically, FIG. 48A is a front perspective view of fastener 5300, FIG. 48B is a back perspective view of fastener 5300, FIG. 48C is a side view of fastener 5300, and FIG. 48D is a 48C is a side cross-sectional view of fastener 5300 taken along line CC of FIG. 48C. Fastener 5300 can include a shaft 5305 having a proximal end 5301, a distal end 5302, and a longitudinal axis 5303. Fastener 5300 may also include a torque connection interface 5306 formed at a proximal end 5301 of shaft 5305 and a self-tapping configuration 5307 formed at a distal end 5302 of shaft 5305. In some embodiments, the fastener 5300 includes a first helical thread 5310 disposed about the shaft 5305 and a second helical thread disposed about the shaft 5305 adjacent to the first helical thread 5310. screws 5320. In these embodiments, the fastener 5300 may include a "dual start" or "dual lead" thread design, with alternating standard threads and reverse threads. However, fastener 5300 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood.

49A-49D show various views of a headless screw or fastener 5600, according to another embodiment of the present disclosure. Specifically, FIG. 49A is a front perspective view of fastener 5600, FIG. 49B is a back perspective view of fastener 5600, and FIG. 49C is a side view of fastener 5600. FIG. 49D is a side cross-sectional view of fastener 5600 taken along line FF of FIG. 49C. Fastener 5600 can include a shaft 5605 having a proximal end 5601, a distal end 5602, and a longitudinal axis 5603. Fastener 5600 may also include a torque connection interface 5606 formed at proximal end 5601 of shaft 5605. In some embodiments, fastener 5600 may include a single helical thread 5610 disposed about shaft 5605. In these embodiments, the fastener 5600 may include a "single start" or "single lead" thread configuration with a standard orientation, as shown in FIG. 49D. However, fastener 5600 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. In some embodiments, fastener 5600 may be sized, shaped, and configured for use as an ACL interference screw for utilization in anterior cruciate ligament (ACL) reconstruction procedures. However, it is also understood that fastener 5600 may be sized, shaped, and configured for use in any bone-tendon-bone graft procedure, or any other procedure/application. It will be understood.

50A and 50B show various views of an interference screw or fastener 5700, according to another embodiment of the present disclosure. Specifically, FIG. 50A is a front perspective view of fastener 5700, and FIG. 50B is a back perspective view of fastener 5700. Fastener 5700 can include a shaft 5705 having a proximal end 5701 and a distal end 5702, a head 5704, and a torque connection interface 5706 formed in head 5704. In some embodiments, fastener 5700 may include a single helical thread 5710 disposed about shaft 5705. In these embodiments, the fastener 5700 may include a "single start" or "single lead" thread configuration with a standard orientation. However, fastener 5700 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. In some embodiments, fastener 5700 may be sized, shaped, and configured for use as an ACL interference screw for utilization in anterior cruciate ligament (ACL) reconstruction procedures. However, it is also understood that fastener 700 may be sized, shaped, and configured for use in any bone-tendon-bone graft procedure, or any other procedure/application. It will be understood. In some embodiments, a system or kit may include at least one ACL interference screw with standard threads and at least one ACL interference screw with reverse threads. In some embodiments, a system or kit may include a plurality of ACL interference screws of various sizes with standard threads and a plurality of ACL interference screws of various sizes with reverse threads. . In some embodiments, a surgeon may select an ACL interference screw, either a standard thread or a reverse thread, and repair the ACL with the selected ACL interference screw.

51A and 51B show various views of a fastener 5800, according to another embodiment of the present disclosure. Specifically, FIG. 51A is a front perspective view of fastener 5800, and FIG. 51B is a back perspective view of fastener 5800. The fastener 5800 has a proximal end 5801 , a distal end 5802 , a self-tapping configuration 5807 formed at the distal end 5802 of the shaft 5805 , and a torque connection interface 5806 formed at the proximal end 5801 of the shaft 5805 , shaft 5805. In some embodiments, self-tapping configuration 5807 can include a forward cutting flute configured to facilitate insertion of fastener 5800 into bone/tissue. In some embodiments, the fastener 5800 may also include a reverse cutting flute (not shown) configured to facilitate removal of the fastener 5800 from the bone/tissue after healing has occurred. . In some embodiments, the fastener 5800 includes a first helical thread 5810 disposed about the shaft 5805 and a second helical thread disposed about the shaft 5805 adjacent to the first helical thread 5810. screws 5820. In these embodiments, the fastener 5800 may include a "dual start" or "dual lead" thread design, with alternating standard threads and reverse threads. However, fastener 5800 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. In some embodiments, fastener 5800 may be sized, shaped, and configured for use in a dental/CMF procedure. However, it will also be understood that fastener 5800 may be sized, shaped, and configured for use in any procedure or application.

52A and 52B show various views of a fastener 5900, according to another embodiment of the present disclosure. Specifically, FIG. 52A is a front perspective view of fastener 5900, and FIG. 52B is a back perspective view of fastener 5900. The fastener 5900 has a proximal end 5901 , a distal end 5902 , a self-tapping configuration 5907 formed at the distal end 5902 of the shaft 5905 , and a torque connection interface 5906 formed at the proximal end 5901 of the shaft 5905 , shaft 5905. In some embodiments, fastener 5900 may include a single helical thread 5910 disposed about shaft 5905. In these embodiments, the fastener 5900 may include a "single start" or "single lead" thread configuration with a standard orientation. However, fastener 5900 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. In some embodiments, fastener 5900 may be sized, shaped, and configured for use in a dental/CMF procedure. However, it will also be understood that fastener 5900 may be sized, shaped, and configured for use in any procedure or application.

53A and 53B show various views of a fastener 51000, according to another embodiment of the present disclosure. Specifically, FIG. 53A is a front perspective view of fastener 51000, and FIG. 53B is a back perspective view of fastener 51000. The fastener 51000 has a proximal end 51001, a distal end 51002, a self-tapping configuration 51007 formed at the distal end 51002 of the shaft 51005, and a torque connection interface 51006 formed at the proximal end 51001 of the shaft 51005. , shaft 51005. In some embodiments, fastener 51000 may include a single helical thread 51010 disposed about shaft 51005. In these embodiments, the fastener 51000 may include a "single start" or "single lead" thread configuration with reverse orientation. However, fastener 51000 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. , will also be understood. In some embodiments, fastener 51000 may be sized, shaped, and configured for use in a dental/CMF procedure. However, it will also be appreciated that fastener 51000 may be sized, shaped, and configured for use in any procedure or application.

FIG. 54A shows a compression fastener or compression screw 51300 according to another embodiment of the present disclosure. In some embodiments, the compression screw 51300 may be utilized to repair a fracture by compressing two or more bone fragments together into one or more fractures. Compression screw 51300 may include any screw configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. Additionally, the compression screw 51300 (or any other fastener described or discussed herein) is oriented toward one of the proximal and distal ends of the compression screw 51300 disclosed herein. a first screw having any of the shapes of a first screw disposed proximate a distal end of the compression screw 51300 and a proximal end and a distal end of the compression screw 51300; a second screw having any of the shapes disclosed herein, oriented to the other end, the second screw being disposed proximate the head of the compression screw 51300; may include screws. In some embodiments, the distal and proximal screws start such that during insertion, the proximal screw nests between the cut distal screws, thereby reducing bone crosscuts. , can be "timed". In some embodiments, the compression screw 51300 may further include forward and/or reverse cutting flutes. In some embodiments, the outer diameter of the head of the compression screw 51300 is greater than the outer diameter of the tip of the compression screw 51300 to increase cortical engagement proximate to the head of the compression screw 51300. obtain. In some embodiments, the compression screw 51300 has a double thread toward the tip of the compression screw 51300 (e.g., with a larger pitch) and a double thread toward the head of the compression screw 51300 (e.g., with a smaller pitch) A single thread may be provided to provide increased thread engagement with the bone toward the tip of the compression screw 51300 while still allowing variable pitch between the tip and the head of the compression screw 51300. FIG. 54B shows a system/system that may include one or more compression screws of various sizes and any suitable support for preparing the bone and/or inserting the compression screw 51300 into the bone. Kit 51350 is shown.

FIG. 55A shows an elongated screw or elongated fastener 51400 according to another embodiment of the present disclosure. In some embodiments, elongated fasteners 51400 may be utilized to repair fractures and/or stabilize bones (eg, in pelvic, hip, and other applications). Elongated fastener 51400 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. FIG. 55B depicts one or more elongated fasteners 51400 of various sizes and any suitable supports that may be utilized to prepare the bone and/or insert the elongated fastener 51400 into the bone. 51450 shows a system/kit 51450 that can include.

FIG. 56A shows a half pin or shunt fastener 51500 according to another embodiment of the present disclosure. In some embodiments, the Schanz fastener 51500 is used to attach external fixators (not shown), such as spatial external fixators, temporary external fixators, etc., during various procedures that may utilize external fixators. can be used to stabilize bones. In some embodiments, the Schanz fastener 51500 may enhance fixation and reduce infection compared to traditional bone pins utilized in external fixators. Schanz fastener 51500 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. FIG. 56B shows one or more Schanz fasteners 51500 of various sizes and any suitable supports that may be utilized to prepare the bone and/or insert the Schanz fastener 51500 into the bone. 51550 shows a system/kit 51550 that can include. In some embodiments, the Schanz fastener 51500 and/or the corresponding insertion tool may include any suitable drive feature configuration (eg, a suitable AO quick connect configuration, etc.).

FIG. 57A shows a fastener 51600 according to another embodiment of the present disclosure. In some embodiments, fastener 51600 may include a cannula 51630 extending through shaft 51605 of fastener 51600. In some embodiments, cannula 51630 can be configured to receive a tool therethrough, such as a drill bit, K-wire 51660, as seen in FIG. 57B. Fastener 51600 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within a given bone/tissue. Additionally, any fastener described herein may also include a cannula. In some embodiments, K-wire 51660 may be inserted into bone/tissue at the treatment site. In some embodiments, a K-wire may be utilized to guide a drill bit to the treatment site to drill a pilot hole. In some embodiments, the tap may also be utilized to preform a thread in the pilot hole. A tap having any suitable shape may also be used with any fastener described or discussed herein to match or substantially match the thread shape of a given fastener. Additionally, any tap may be configured to be self-tapping or non-self-tapping. In some embodiments, the K-wire 51660 may be inserted through the cannula 51630 of the fastener 51600 and the fastener 51600 may be guided over the K-wire to the treatment site for insertion into the pilot hole. K-wire 51660 may have a shaft 51640 that is guided and/or retained within cannula 51630 during insertion. In some embodiments, the minor diameter of the fastener 51600 may be selected to match or substantially match the diameter of the pilot hole to avoid bone rupture.

FIG. 58 shows a bone/soft tissue repair anchor or fastener 51700 according to another embodiment of the present disclosure. In some embodiments, fastener 51700 is configured to couple suture 51730 (or suture tape, etc.) to fastener 51700 to facilitate bone/soft tissue repair procedures using suture 51730. Additionally, a connection configuration 51740 may be included. In some embodiments, connection arrangement 51740 may be internally disposed within fastener 51700. However, it will be appreciated that suture 51730 may be coupled to fastener 51700 in any suitable manner and at any location on/within fastener 51700. Fastener 51700 may include any thread configuration, feature, or form described or discussed herein to achieve optimal fixation within a given bone/soft tissue. In some embodiments, the outer diameter of the head of the fastener 51700 is greater than the outer diameter of the tip of the fastener 51700 to increase engagement of bone/tissue proximate the head of the fastener 51700. obtain.

59A and 59B show various views of a fastener 51800 engaged with a plate 51830, according to another embodiment of the present disclosure. In some embodiments, plate 51830 may include a lateral distal fibula plate (LDFP) to repair the distal fibula (not shown). In some embodiments, the fastener 51800 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within the distal fibula. . In some embodiments, the LDFP may include a locking LDFP with bone plate holes configured to receive both locking and non-locking fasteners to achieve lower head protrusion at desired locations. . As previously mentioned, any of the fasteners disclosed or contemplated herein include a locking screw located on or near the head of the fastener for locking the fastener to an implant (such as a bone plate). may include any locking configuration such as. A locking screw located on or near the head of the fastener may match the configuration (e.g., pitch, shape, etc.) of the fastener's lead thread. Additionally, any bone plate (or other implant or component) utilized in conjunction with the fasteners disclosed herein may also engage threads of the fastener with threads of the bone plate to facilitate fastening. The device may include a thread formed in the bone plate that may match (or substantially match) the general configuration (e.g., pitch, shape, etc.) of the fastener thread to couple the device to the bone plate. .

60A and 60B show various views of a fastener 51900 engaged with a plate 51930, according to another embodiment of the present disclosure. In some embodiments, plate 51930 may include a proximal tibial plate configured to repair proximal tibia 51940. In some embodiments, the proximal tibial plate comprises a locking proximal tibial plate with bone plate holes configured to receive both locking and non-locking fasteners, and less Protrusion of the head can be achieved. Fastener 51900 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within proximal tibia 51940.

FIG. 61 shows a fastener 52000 and a plate 52030 according to another embodiment of the present disclosure. In some embodiments, plate 52030 may comprise a distal femoral fracture repair plate configured to repair a distal femur (not shown). In some embodiments, the distal femoral fracture repair plate comprises a locking distal femoral fracture repair plate with bone plate holes configured to receive both locking and non-locking fasteners. , less head protrusion can be achieved at desired locations. Fastener 52000 may include any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within the distal femur.

FIG. 62A shows a periprosthetic fracture repair plate (PFRP) or plate 52130 according to another embodiment of the present disclosure. FIG. 62B shows a side view of a fractured femur 52140 and FIG. 62C shows a side view of the femur 52140 after the fracture has been repaired with a plate 52130 coupled to the femur 52140 via fasteners 52100. shows. In some embodiments, the plate 52130 comprises a locking PFRP with bone plate holes configured to receive both locking and non-locking fasteners to provide less head protrusion in desired locations. It can be achieved. The fastener 52100 can be adapted to any of the methods described or contemplated herein to achieve optimal fixation within the femur 52140 or any other bone that may require repair of a periprosthetic fracture. May include thread configurations, features, or configurations.

FIG. 63A shows a fastener 52300, FIG. 63B shows a plate 52330, and FIG. 63C shows another plate 52340, according to embodiments of the present disclosure. In some embodiments, plates 52330, 52340 may include pelvic bone repair plates (eg, quad plates, etc.) configured for use with fasteners 52300. In some embodiments, plates 52330, 52340 may include percutaneous pelvic bone repair plates. In some embodiments, the plates 52330, 52340 include locking pelvic bone repair plates with bone plate holes configured to receive both locking and non-locking fasteners, and more Less head protrusion can be achieved. Fastener 52300 includes any thread configuration, feature, or configuration described or discussed herein to achieve optimal compression and fixation within the pelvis or any other bone. obtain.

64A and 64B show various views of a fastener 52400 coupling a plate 52430 to a proximal humerus 52440, according to another embodiment of the present disclosure. In some embodiments, plate 52430 may include a proximal humeral plate configured to repair proximal humerus 52440. In some embodiments, the proximal humeral plate comprises a locking proximal humeral plate with bone plate holes configured to receive both locking and non-locking fasteners at the desired location. Achieves less head protrusion. The fastener 52400 may incorporate any thread configuration, feature, or configuration described or discussed herein to achieve optimal fixation within the proximal humerus 52440 or any other bone. I can prepare.

Any of the fasteners described or discussed herein may be configured to be removed and replaced during a corrective procedure by simply unscrewing and removing the fastener from the bone/tissue in which it resides. . Additionally, the fasteners described herein may advantageously be removed from bone without removing any significant amount of bone during the removal process to preserve the bone. In this way, to provide an immediate, removable connection between the implant and the bone, the implant is machined without being bonded to the bone or integrated through bone ingrowth. can be integrated with the bone. Accordingly, repair procedures utilizing the fasteners described herein may be less traumatic to the bone and result in improved patient outcomes. However, it will also be understood that any of the fasteners described or discussed herein may be utilized with a bonding agent, if desired.

Any procedure/method disclosed herein includes one or more steps or actions for carrying out the described method. Method steps and/or actions may be interchanged with each other. In other words, the order and/or use of particular steps and/or actions may be modified, unless a particular order of steps or actions is required for proper operation of an embodiment.

References throughout this specification to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. means. Therefore, all quotations or variations thereof mentioned throughout this specification are not necessarily all referring to the same embodiment.

Similarly, in the above description of embodiments, it should be understood that various features are grouped into a single embodiment, figure, or description thereof for the purpose of simplifying the disclosure. . This method of disclosure, however, is not to be interpreted as reflecting an intention that any embodiment requires more features than are explicitly recited in that embodiment. Rather, inventive aspects reside in combinations of fewer features than all of the features of a single previously described disclosed embodiment.

The recitation of the term "first" with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements listed in means-plus-function form are intended to be construed in accordance with 35 U.S.C. 112(f). It will be apparent to those skilled in the art that changes may be made in the details of the embodiments described above without departing from the basic principles described herein.

The terms "connected," "coupled," and "in communication" refer to two or more interactions, including mechanical, electrical, magnetic, electromagnetic, fluidic, and thermal interactions. refers to any form of interaction between entities in Two components may be operably coupled to each other without being in direct contact with each other. The term "coupled" can include components that are integrally coupled to each other, as well as components that are removably and/or non-removably coupled to each other. The term "abutting" refers to items that may be in direct physical contact with each other, but the items are not necessarily attached together. The term "fluid communication" refers to two or more structures connected such that fluid in one structure can move to another structure. Additionally, the term "substantially" as defined herein means within ±20% of a target value, measured value, or desired characteristic.

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

Claims (65)

A femoral fixation device, the femoral fixation device comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft, the helical screw comprising:
a first undercut surface;
a second undercut surface;
when the femoral fixation device is implanted within the neck and head of the femur;
the first location, the second location, and the helical screw therebetween are located within the head of the femur;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal and distal ends of the shaft;
the helical thread, wherein the first and second undercut surfaces are configured to transmit at least one force from the head of the femur to the neck of the femur;
A femoral fixation device comprising: The femoral fixation device of claim 1, wherein the first undercut surface is angled toward the proximal end of the shaft and the second undercut surface is angled toward the proximal end of the shaft. A femoral fixation device characterized in that it is angled toward said distal end. 3. The femoral fixation device of claim 2, wherein when the femoral fixation device is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft, the helical thread is A femoral fixation device comprising at least one chevron shape oriented toward the proximal end. 4. The femoral fixation device of claim 3, wherein the helical screw includes a plurality of chevron shapes oriented toward the proximal end of the shaft. 2. The femoral fixation device of claim 1, wherein when the femoral fixation device is viewed in cross section along a plane intersecting the longitudinal axis of the shaft, the helical thread is A femoral fixation device comprising at least one partial crescent shape oriented toward the proximal end. 6. The femoral fixation device of claim 5, wherein the helical screw includes a plurality of partial crescent shapes oriented toward the proximal end of the shaft. Device. The femoral fixation device of claim 1, wherein the proximal end of the shaft includes a headless cylindrical shape. A femoral fixation assembly, the femoral fixation assembly comprising:
A femoral fastener, the femoral fastener comprising:
a shaft including a proximal end, a distal end, and a longitudinal axis;
a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft and including a concave undercut surface. a bone fastener;
A femoral support member, the femoral support member comprising:
a proximal end;
a distal end;
a longitudinal axis;
a passageway formed through the femoral support member at an angle relative to the longitudinal axis of the femoral support member;
Once the femoral fastener is implanted within the neck and head of the femur and the femoral support member is implanted along the longitudinal axis of the femur;
at least a portion of the shaft is slidably received within the passageway of the femoral support member;
The concave undercut surface is oriented toward the proximal end of the femoral fastener and configured to transmit at least one force from the femoral head to the femoral neck. , and the femoral support member. 9. The femoral fixation assembly of claim 8, wherein the concave undercut surface includes at least one substantially flat surface. 10. The femoral fixation assembly of claim 9, wherein the concave undercut surface includes a plurality of flat surfaces angled with respect to each other. 11. The femoral fixation assembly of claim 10, wherein when the femoral fastener is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft, the concave undercut surface A femoral fixation assembly comprising at least one chevron shape oriented toward the proximal end of the shaft. 9. The femoral fixation assembly of claim 8, wherein the concave undercut surface includes at least one curved surface. 13. The femoral fixation assembly of claim 12, wherein when the femoral fastener is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft, the concave undercut surface comprises: A femoral fixation assembly comprising at least one partial crescent shape oriented toward the proximal end of the shaft. 9. The femoral fixation assembly of claim 8, wherein when the femoral fastener is viewed in cross-section along a plane intersecting the longitudinal axis of the shaft, the concave undercut surface: A femoral fixation assembly comprising at least one curved shape having an intermediate portion oriented toward the proximal end of the femoral fastener. A femoral fixation assembly, the femoral fixation assembly comprising:
A femoral fastener, the femoral fastener comprising:
a shaft including a proximal end, a distal end, and a longitudinal axis;
a helical screw disposed about the shaft along the longitudinal axis between a first position and a second position along the shaft;
A femoral support member, the femoral support member comprising:
a proximal end;
a distal end;
a longitudinal axis;
A passageway, the passageway comprising:
a first opening;
a second opening opposite to the first opening,
a femoral support member, the passageway being formed through the femoral support member at an angle relative to the longitudinal axis of the femoral support member;
A stop member, the stop member comprising:
a proximal end;
a distal end;
a longitudinal axis;
a stop member protrusion having a preselected length;
when the femoral fastener is implanted within the neck and head of the femur and the femoral support member is oriented relative to the longitudinal axis of the femur;
at least a portion of the shaft is slidably received within the passageway through the first opening;
at least a portion of the stop member is received within the passageway through the second opening;
A space having a predetermined length is defined within the passageway between the distal end of the stop member and the proximal end of the shaft based on the preselected length of the stop member projection. the stop member formed in;
A femoral fixation assembly comprising: 16. The femoral fixation assembly of claim 15, wherein the femoral support member includes a bone plate. 16. The femoral fixation assembly of claim 15, wherein the femoral support member includes an intramedullary nail. 16. The femoral fixation assembly of claim 15, wherein the angle of the passageway with respect to the longitudinal axis of the femoral support member includes an acute angle. 16. The femoral fixation assembly of claim 15, wherein the predetermined length of the space within the passageway is greater than zero. 16. The femoral fixation assembly of claim 15, wherein the predetermined length of the space within the passageway is zero. A method of implanting a femoral fixation device within a femur, the method comprising:
forming a bone tunnel through the neck of the femur and into the head of the femur;
inserting the femoral fixation device into the bone tunnel, the femoral fixation device comprising:
a shaft having a proximal end, a distal end, and a longitudinal axis;
a helix including a concave undercut surface disposed about the shaft and oriented toward the proximal end of the shaft between a first location and a second location along the shaft; a screw;
the helix in the head of the femur such that the concave undercut surface is positioned to transmit at least one force from the head of the femur to the neck of the femur; arranging a portion of the shaft that includes a thread. 22. The method of claim 21, further comprising forming a female bone screw around the bone tunnel, the female bone screw receiving the helical screw therein. A method comprising: 23. The method of claim 22, wherein placing the portion of the shaft containing the helical screw within the head of the femur further comprises rotating the shaft and causing the helical screw to rotate. A method comprising inserting the female bone screw disposed about the bone tunnel. 22. The method of claim 21, further comprising connecting the proximal end of the shaft to a first portion of a passageway formed through a femoral support member oriented relative to the longitudinal axis of the femur. A method comprising: inserting into an aperture. 25. The method of claim 24, further comprising: inserting a distal end of a stop member into a second opening of the passageway opposite the first opening; forming a space having a predetermined length in the passage between the distal end of the stop member and the proximal end of the shaft based on the length of the shaft. How to do it. A pedicle fastener, the pedicle fastener comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
the shaft, the shaft having a small diameter;
a helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft, the helical thread comprising:
a first undercut surface;
a second undercut surface;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal and distal ends of the shaft;
A vertebral pedicle fastener, characterized in that the small diameter of the shaft is constant. 27. The pedicle fastener of claim 26, further comprising an attachment arrangement coupled to the proximal end of the shaft and configured to be secured to an instrument. Root fasteners. 28. The pedicle fastener of claim 27, wherein the attachment arrangement includes a polyaxial head having a first hemispherical surface. 29. The pedicle fastener of claim 28, wherein the instrument is adapted to secure discrete tulips to the polyaxial head in any of a variety of relative orientations. A pedicle fastener comprising the separate tulip having a second hemispherical surface configured to engage the first hemispherical surface. 30. The pedicle fastener of claim 29, wherein the separate tulip is further configured to secure to the separate tulip at least one aperture and a rod received through the at least one aperture. a locking member configured. 28. The pedicle fastener of claim 27, wherein the attachment arrangement includes an integrated tulip having at least one aperture configured to receive at least a portion of the instrument therethrough. A pedicle fastener comprising: 32. The pedicle fastener of claim 31, wherein the instrument includes a rod receivable through the at least one aperture of the integrated tulip, the integrated tulip A pedicle fastener comprising a locking member configured to secure to the integrated tulip. A method for preventing bone rupture, the method comprising:
forming a hole in the bone, the hole having a diameter of a bone hole;
inserting a bone fastener into the hole, the bone fastener comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
the shaft having a small diameter;
a helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft, the helical thread comprising:
a first undercut surface;
a second undercut surface;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal and distal ends of the shaft;
A method characterized in that the small diameter of the main portion of the shaft is not larger than the diameter of the bone hole, in order to reduce radially outward loading forces applied to the bone and prevent bone rupture. . 34. The method of claim 33, wherein the minor diameter of the main portion of the shaft is equal to the diameter of the bone hole. 34. The method of claim 33, wherein the minor diameter of the main portion of the shaft is less than the diameter of the bone hole. 36. The method of claim 35, wherein the minor diameter of the main portion of the shaft is 0 mm to 0.1 mm less than the diameter of the bone hole. 36. The method of claim 35, wherein the minor diameter of the main portion of the shaft is at least 0.1 mm less than the diameter of the bone hole. 36. The method of claim 35, wherein the minor diameter of the main portion of the shaft is at least 0.2 mm less than the diameter of the bone hole. 34. The method of claim 33, wherein the minor diameter of the main portion of the shaft is constant. A bone fastener, the bone fastener comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
the shaft, the shaft having a small diameter;
a helical screw disposed about the shaft, along the longitudinal axis between the proximal end and the distal end of the shaft, defining a larger diameter of the bone fastener; The spiral screw is
a first undercut surface;
a second undercut surface;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal end and the distal end of the shaft;
A bone fastener characterized in that the ratio of the large diameter to the small diameter is less than 1.50. 41. The bone fastener of claim 40, wherein the ratio of the large diameter to the small diameter is less than 1.25. 41. The bone fastener of claim 40, wherein the ratio of the large diameter to the small diameter is less than 1.10. 41. The bone fastener of claim 40, wherein the ratio of the large diameter to the small diameter is less than 1.05. 41. The bone fastener of claim 40, wherein at least a portion of the bone fastener is configured to be received in an intramedullary canal of a bone. 45. The bone fastener of claim 44, further comprising an attachment arrangement at the proximal end of the shaft configured to be adjustably secured to an instrument. . A pedicle fastener, the pedicle fastener comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
a helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft, the helical thread comprising:
a first undercut surface;
a second undercut surface;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal end and the distal end of the shaft;
an integrated attachment configuration of the proximal end of the shaft configured to be adjustably secured to a spinal stabilization device. 47. The pedicle fastener of claim 46, wherein the integrated attachment arrangement comprises a first hemisphere configured to be polyaxially adjustably secured to the spinal stabilization device. A pedicle fastener comprising a polyaxial head having a face. 48. The pedicle fastener of claim 47, wherein the spinal stabilization device polyaxially adjustably secures discrete tulips to the polyaxial head in any of a variety of relative orientations. A pedicle fastener comprising: the separate tulip having a second hemispherical surface configured to engage the first hemispherical surface of the polyaxial head. 49. The pedicle fastener of claim 48, wherein the separate tulip is further configured to secure to the separate tulip at least one aperture and a rod receivable through the at least one aperture. a locking member configured. 47. The pedicle fastener of claim 46, wherein the integrated attachment arrangement has at least one aperture configured to receive at least a portion of the spinal stabilization device therethrough. , a pedicle fastener comprising an integrated tulip. 51. The pedicle fastener of claim 50, wherein the spinal stabilization device includes a rod receivable through the at least one aperture of the integrated tulip. Ingredients. 52. The pedicle fastener of claim 51, wherein the integrated tulip further includes a locking member configured to secure the rod to the integrated tulip. Pedicle fastener. A pedicle fastener stabilization system, the system comprising:
A pedicle fastener, the pedicle fastener comprising:
a shaft including a proximal end, a distal end, and a longitudinal axis;
a polyaxial head at the proximal end of the shaft;
a first helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft and including a first concave undercut surface;
a second helical thread disposed about the shaft adjacent to the first helical thread and including a second concave undercut surface;
The first concave undercut surface and the second concave undercut surface are angled toward one of the proximal end and the distal end of the shaft. a root fastener;
a tulip configured to be multiaxially adjustable and fixed to the multiaxial head;
a spinal stabilization rod securable to the tulip. 54. The pedicle fastener stabilization system of claim 53, wherein the multi-axial head is integrally formed with the pedicle fastener. . 55. The pedicle fastener stabilization system of claim 54, wherein the polyaxial head includes a first hemispherical surface. 56. The pedicle fastener stabilization system of claim 55, wherein the tulip polyaxially adjustably secures the tulip to the polyaxial head in any of a variety of relative orientations. a pedicle fastener stabilization system comprising: a second hemispherical surface configured to engage the first hemispherical surface of the multi-axis head to provide a pedicle fastener stabilization system; 54. The pedicle fastener stabilization system of claim 53, wherein the tulip includes at least one aperture configured to receive the spinal stabilization rod therethrough. Pedicle fastener stabilization system. 58. The pedicle fastener stabilization system of claim 57, wherein the tulip includes a locking member configured to secure the spinal stabilization rod to the tulip. Root fastener stabilization system. 54. The pedicle fastener stabilization system of claim 53, wherein the minor diameter of the shaft is constant. A method of implanting a bone fastener assembly, the method comprising:
Inserting a bone fastener into a bone, the bone fastener comprising:
A shaft, the shaft comprising:
a proximal end;
a distal end;
a longitudinal axis;
a helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft, the helical thread comprising:
a first undercut surface;
a second undercut surface;
the first undercut surface is angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other of the proximal end and the distal end of the shaft;
a mounting arrangement for the proximal end of the shaft configured to be adjustably secured to an instrument;
orienting the instrument to a selected orientation for the mounting configuration;
attaching the instrument to the mounting configuration in the selected orientation. 61. The method of claim 60,
the attachment arrangement of the proximal end of the shaft is configured to be polyaxially adjustably secured to the instrument;
Adjusting the orientation of the instrument to the selected orientation relative to the mounting configuration further comprises:
polyaxially adjusting the orientation of the instrument to a selected one of a plurality of possible polyaxially distinct relative orientations with respect to the mounting configuration; A method characterized by: 62. The method of claim 61, comprising:
the mounting arrangement includes a multi-axis head having a first hemispherical surface;
the device engages the first hemispherical surface of the multi-axial head to polyaxially adjustably secure discrete tulips to the multi-axial head in any of a variety of relative orientations; A method comprising: said separate tulip having a second hemispherical surface configured to. 63. The method of claim 62, wherein the separate tulips include:
at least one aperture;
a locking member configured to secure a rod received through the at least one aperture to the separate tulip. 61. The method of claim 60, further comprising:
drilling a pilot hole in the bone;
inserting the shaft of the bone fastener into the pilot hole. 65. The method of claim 64, further comprising:
tapping a bone screw into the bone to form a female bone screw around the pilot hole;
inserting the helical screw into the female bone screw.

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