Patent Application
20180064476
This disclosure relates generally to bone fixation implants, and in particular relates to a bone plate that is configured to lockingly receive a bone screw at an angular orientation in a range of permissible angular orientations at which the bone plate can lockingly receive the bone screw.
When bones are damaged through trauma, disease, distraction osteogenesis, or orthognathic surgery, the defect is typically reduced, and bone fixation plates are commonly applied to the bone on opposite sides of the defect to ensure union in the desired position. Bone plates are typically made from a rigid material, such as titanium, and include fixation holes that are sized to be driven through the fixation holes and into the underlying bone to secure the bone plate to the bone. One common bone screw used in such application is generally referred to as a compression screw. Compression screws have unthreaded heads and threaded shafts. Accordingly, the compression screw can be driven through the fixation hole and into the underlying bone until the head applies a compression force against the bone plate toward the underlying bone. Another common bone screw used in such applications is generally referred to as a locking screw. Locking screws have threaded heads and threaded shafts. Accordingly, the locking screw can be driven through the fixation hole and into the underlying bone until the head threadedly mates with the bone plate in the fixation hole. Thus, the head of the locking screw does not apply a compressive force against the bone plate toward the underlying bone.
Conventionally, locking screws were inserted through the screw hole along the central screw hole axis in order to ensure that the threaded screw head mates with the bone plate in the threaded fixation hole. Recently, however, bone plates have been developed having threaded fixation holes that are configured to receive locking screws at different trajectories within a range of trajectories whereby the bone plate threadedly mates with the locking screw head in the threaded hole. While bone plates having such holes, commonly referred to as variable angle holes, have proved to be satisfactory for their intended purpose, improved variable angle holes are nevertheless desired.
In accordance with one embodiment, a bone plate can include an inner surface configured to face bone, and an outer surface opposite the inner surface. The bone plate can further include an internal surface that extends from the outer surface to the inner surface, the internal surface defining a fixation hole that extends from the outer surface to the inner surface along a central hole axis and is sized to receive a shaft of a bone anchor that extends out with respect to a threaded head of the bone anchor along a central anchor axis. The internal surface can define 1) a tapered threaded region that includes a plurality of threaded columns that are circumferentially spaced from each other about the central hole axis and separated from each other by a corresponding plurality of recesses, and 2) a second region that extends between the tapered threaded region and the outer surface, the second region being concave as it extends along both a plane that includes the central hole axis, and a plane that is oriented perpendicular with respect to the central hole axis. The tapered threaded region can be configured to threadedly mate with the threaded head while the bone anchor is oriented at a first orientation with respect to the central hole axis. The tapered region can be further configured to threadedly mate with the threaded head when the bone anchor is oriented at a second orientation angle with respect to the central anchor axis that is different than the first orientation. The second region can be configured to receive a compression force from a compression screw that is inserted into the fixation hole such that a head of the compression screw abuts the second region.
The foregoing summary, as well as the following detailed description, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the reconstruction device and related method thereof, there is shown in the drawings exemplary embodiments, in which like reference numerals correspond to like reference numerals throughout. The reconstruction device and related methods are not limited to the specific embodiments and methods disclosed, and reference is made to the claims for that purpose.
Referring initially to
The bone fixation system 20 can include a bone plate 30 and a plurality of bone anchors 32 that are configured to fix the bone plate 30 to the underlying bone 22, and in particular to each of the first and second bone segments 22 and 24. The bone anchors 32 include a head 33 and a shaft 35 that extends out with respect to the head 33 along a central anchor axis 53. The shaft 35 can extend directly from the head, or can extend from a neck that is disposed between the head 33 and the shaft 35. The shaft 35 can be threaded, such that the bone anchor 32 is configured as a bone screw 37 whose shaft 35 extends out relative to the head 33 along the central anchor axis 53, which can also be referred to as a central screw axis. The threaded shaft 35 can be configured to threadedly purchase in the underlying bone 22. For instance, one or more up to all of the bone screw 37 can be configured as a cortical screw whose threaded shaft 35 is designed and configured to threadedly mate to cortical bone. Alternatively or additionally, one or more of the bone screws 37 can be configured as a cancellous screw whose threaded shaft 35 is designed and configured to threadedly mate to cancellous bone. It is appreciated that cancellous bone screws have threads that have a greater pitch than threads of cortical bone screws. Further, the threads of cancellous bone screws typically extend out from the shaft of the bone screw a greater distance than the threads of cortical bone screws.
The bone plate 30 defines a bone plate body 31. The bone plate body 31, and thus the bone plate 30, defines an inner surface 34 configured to face the underlying bone 22, and an outer surface 36 that is opposite the inner surface 34 along a transverse direction T. The bone plate 30 further defines a plurality of fixation holes 38 that extend through the bone plate body 31 from the inner surface 34 to the outer surface 36. In particular, the bone plate body 31, and thus the bone plate 30, includes a plurality of internal surfaces 39 that extend from the outer surface 36 to the inner surface 34 and defines a respective fixation hole 38 that extends from the outer surface 36 to the inner surface 34 along a central hole axis 45 (see
The fixation holes 38 are sized to receive the shaft 35 of a respective one of the bone screws 37. Thus, the bone screws 37 that extend through fixation holes 38 are permanent bone screws, meaning that they remain after completion of the surgical procedure. This is distinguished from temporary fixation holes that, for instance, can be configured to receive temporary fixation members, such as Kirschner wires that are removed prior to completion of the surgical procedure. In this regard, the fixation holes 38 can be referred to as permanent fixation holes. Accordingly, during operation, the shaft 35 of the bone screw 37 can be inserted through a respective one of the fixation holes 38 and into the underlying bone 22. The bone screw 37 can then be rotated so as to cause the threaded shaft 35 to be driven into the underlying bone as the threaded shaft 35 threadedly purchases with the underlying bone. The threaded shaft 35 can be driven into the underlying bone until the head 33 engages the bone plate 30. One or more up to all of the bone screws 37 can be configured as a compression screw whose head 33 is configured to bear against the bone plate 30 so as to apply a compressive force against the bone plate 30 toward the underlying bone 22 when the shaft 35 is driven further into the underlying after the head 33 has contacted the internal surface 39. The shaft 35 can be driven into the underlying bone a sufficient distance until the desired compressive force has been imparted onto the bone plate 30. The head 33 of the compression screw is often unthreaded. Similarly, at least a portion up to an entirety of the internal surface 39 can be unthreaded.
In another example, one or more up to all of the bone screw 37 can be configured as locking screws that are configured to lock to the bone plate 30. In particular, the head 33 can be externally threaded. The internal surface 39 can be similarly threaded so as to be configured to threadedly mate with the threaded head 33. Accordingly, during operation, the shaft 35 can be inserted through the fixation hole 38 and driven into the underlying bone as described above. In particular, when the bone screw 37 is a locking screw, rotation of the screw 37 causes the threaded head to threadedly mate with the internal surface 39. As a result, the screw head 33 fastens the bone plate 30 to the underlying bone without applying a compressive force onto the bone plate 30 against the underlying bone. The bone plate 30 can be spaced from the underlying bone when locked to the head 33. Alternatively, the bone plate 30 can abut the underlying bone when locked to the head 33. At least a portion of the internal surface 39 is typically tapered as it extends in an axially inward direction from the outer surface 36 toward the inner surface 34. Thus, the internal surface 39 is configured to prevent the head 33 from passing completely through the fixation hole 38. The head 33 can be constructed in accordance with any embodiment as described in U.S. Pat. No. 8,574,268, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein. Thus, it is appreciated that the head 33 can define at least one external thread that is circumferentially continuous about the central anchor axis 53. It should be appreciated, however, that the head 33 can be alternatively constructed in any manner desired so as to threadedly mate with the internal surface 39 as described herein.
Referring now to
The bone screw 37 is configured to be inserted into the fixation hole 38 such that the central anchor axis 53 is at one of a plurality of orientations with respect to the central hole axis 45 within a range of orientations at which the threaded head 33 is configured to threadedly mate with the at least one thread 46 in the fixation hole 38. For instance, the bone screw 37 is configured to be inserted into the fixation hole 38 such that the central anchor axis 53 is at one of a plurality of angles within a range of angles defined by the central anchor axis 53 and the central hole axis 45 at which the threaded head 33 is configured to threadedly mate with the at least one thread 46 in the fixation hole 38. The range of angles can be from approximately zero degrees to approximately 15 degrees. Thus, the range of angles can define a cone of up to thirty degrees. Thus, it can be said that the at least one thread 46 is configured to threadedly mate with the threaded screw head 33 while the bone screw 37 is inserted into the fixation hole 38 such that the central anchor axis 53 is oriented at a first angle with respect to the central hole axis 45, and the at least one thread 46 is further configured to threadedly mate with the threaded screw head 33 when the bone screw 37 is inserted into the fixation hole 38 such that the central anchor axis 53 is oriented at a second angle with respect to the central hole axis 45 that is different than the first angle. At least one or both of the first and second angles can be non-zero angles. Alternatively, the central anchor axis 53 can be coincident with the central hole axis 45 in one of the orientations in the range of orientations. The threads 46 and the threads of the head 33 are defined prior to insertion of the bone screw 37 into the variable angle locking hole 44. That is, the internal surface 39 is not designed or configured to cut threads into the bone screw head 33. Similarly, the bone screw head 33 is not designed or configured to cut threads into the internal surface 39. The variable angle locking hole 44 is described in more detail below.
Referring now to
In one example, all of the fixation holes 38 in the first plate portion 40 are variable angle locking holes 44. Further, in one example, all of the fixation holes 38 in the second plate portion 42 are compression holes configured to receive cortical bone screws. Further, at least one or more up to all of the compression holes can be configured as slots that are elongate along a central longitudinal axis of the bone plate to allow for positional flexibility of the bone screw received therein. Alternatively or additionally, at least one or more up to all of the compression holes can have a circular cross-section so as to locate the position of the bone screw received therein. As described above, however, it should be appreciated that the bone plate 30 can be configured to attach to any region or regions of any suitable bone in the human or animal anatomy suitable for bone plate fixation.
Referring to
Referring now to
The fixation holes 38 of the head portion 41 can be arranged in a first row 50a and a second row 50b that is offset from the first row 50a in the proximal direction. The first row 50a can contain a greater number of fixation holes 38 than the second row 50b. For instance, the first row 50a can contain double the number of fixation apertures of the second row 50b. In one example, the first row 50a can include four fixation holes 38, with first and second ones 38a and 38b of the fixation holes 38 of the first row 50a disposed on a first side of a longitudinal centerline of the bone plate 30, and third and fourth ones 38c and 38d of the fixation holes 38 of the first row 50a disposed on a second side of the longitudinal centerline of the bone plate 30 opposite the first side. The first one 38a of the fixation holes 38 of the first row 50a can be disposed laterally outward with respect to the second one 38b of the fixation holes 38 of the first row 50a. Similarly, the third one 38c of the fixation holes 38 of the first row 50a can be disposed laterally outward with respect to the fourth one 38d of the fixation holes 38 of the first row 50a. Further still, the central hole axis of the fourth one 38d of the fixation holes 38 of the first row 50a can be offset from the central hole axis of all other ones of the fixation holes 38 of the first row 50a in the distal direction. It should be appreciated, of course, that the first row 50a can include any number of fixation holes 38 as desired, arranged as desired. Further, the first and second rows 50a and 50b can be linear rows or can be curved as desired. In one example, the central hole axes of the fixation holes 38 of the fixed row lie on a nonlinear path.
The second row 50b can include likewise include any number of fixation holes 38 as desired. In one example, the second row 50b can include first and second ones 38e and 38f, respectively, of the fixation holes 38. The central hole axes of the fixation holes 38 of the second row 50b are spaced from the central hole axes of the fixation holes 38 of the first row 50a in the proximal direction. The first one 38e of the fixation holes 38 of the second row 50b can be disposed between the first and second ones 38a and 38b of the fixation holes 38 of the first row 50a with respect to the lateral direction A. Similarly, the second one 38f of the fixation holes 38 of the second row 50b can be disposed between the third and fourth ones 38c and 38d of the fixation holes 38 of the first row 50a with respect to the lateral direction A.
The first and second ones 38a and 38b of the fixation holes 38 of the first row 50a and the first one 38e of the fixation holes 38 of the second row 50b can be configured to receive bone screws that are driven into one of the lunate fossa and the sigmoid notch. The third one 38c of the fixation holes 38 of the first row 50a can be configured to receive a bone screw that is driven into the scaphoid fossa. The fourth one 38d of the fixation holes 38 of the first row 50a and the second one 38f of the fixation holes 38 of the second row 50b can be configured to receive bone screws that are driven into one of the styloid process. It is recognized that the central hole axes 45 of one or more up to all of the fixation holes 38a-38f can be perpendicular to one or both of the bone plate surfaces 34 and 36, or nonperpendicular to one or both of the bone plate surfaces 34 and 36. In one example, the respective central hole axes 45 of the fixation holes 38d and 38f may define an angle with respect to one or both of the bone plate surfaces 34 and 36 that is less than the angle defined by the central hole axes of the other fixation holes 38a-38c and 38e and the one or both of the bone plate surfaces 34 and 36. Thus, the bone fixation holes 38d and 38f can be said to have increased angulation with respect to the other fixation holes 38a-38c and 38e. The increased angulation can allow bone screws that are inserted through the fixation holes 38d and 38f to be aligned with the styloid reach for fixation to the styloid reach.
Referring now to
The fixation holes 38 of the head portion 41 can be arranged in a first row 50a and a second row 50b that is offset from the first row 50a in the proximal direction. The first row 50a can contain a greater number of fixation holes 38 than the second row 50b. For instance, the first row 50a can contain double the number of fixation apertures of the second row 50b. In one example, the first row 50a can include four fixation holes 38, with first and second ones 38a and 38b of the fixation holes 38 of the first row 50a disposed on a first side of a longitudinal centerline of the bone plate 30, and third and fourth ones 38c and 38d of the fixation holes 38 of the first row 50a disposed on a second side of the longitudinal centerline of the bone plate 30 opposite the first side. The first one 38a of the fixation holes 38 of the first row 50a can be disposed laterally outward with respect to the second one 38b of the fixation holes 38 of the first row 50a. Similarly, the third one 38c of the fixation holes 38 of the first row 50a can be disposed laterally outward with respect to the fourth one 38d of the fixation holes 38 of the first row 50a. Further still, the central hole axis of the fourth one 38d of the fixation holes 38 of the first row 50a can be offset from the central hole axis of all other ones of the fixation holes 38 of the first row 50a in the distal direction. It should be appreciated, of course, that the first row 50a can include any number of fixation holes 38 as desired, arranged as desired. Further, the first and second rows 50a and 50b can be linear rows or can be curved as desired. In one example, the central hole axes of the fixation holes 38 of the fixed row lie on a nonlinear path.
The second row 50b can include likewise include any number of fixation holes 38 as desired. In one example, the second row 50b can include first and second ones 38e and 38f, respectively, of the fixation holes 38. The central hole axes of the fixation holes 38 of the second row 50b are spaced from the central hole axes of the fixation holes 38 of the first row 50a in the proximal direction. The first one 38e of the fixation holes 38 of the second row 50b can be disposed between the first and second ones 38a and 38b of the fixation holes 38 of the first row 50a with respect to the lateral direction A. Similarly, the second one 38f of the fixation holes 38 of the second row 50b can be disposed between the third and fourth ones 38c and 38d of the fixation holes 38 of the first row 50a with respect to the lateral direction A.
The first and second ones 38a and 38b of the fixation holes 38 of the first row 50a and the first one 38e of the fixation holes 38 of the second row 50b can be configured to receive bone screws that are driven into one of the lunate fossa and the sigmoid notch. The third one 38c of the fixation holes 38 of the first row 50a can be configured to receive a bone screw that is driven into the scaphoid fossa. The fourth one 38d of the fixation holes 38 of the first row 50a and the second one 38f of the fixation holes 38 of the second row 50b can be configured to receive bone screws that are driven into one of the styloid process. As described above with respect to
Referring now to
Each of the first and second arms 41a and 41b can include at least one fixation hole 38 such as a plurality of fixation holes 38. One or more up to all of the fixation apertures in the plate head portion 41 can be configured as variable angle locking holes 44. The fixation holes 38 of each of the arms 41a and 41b can be arranged in a respective first row 50a and a second row 50b that is offset from the first row 50a in the proximal direction. The first row 50a can be oriented substantially parallel to the outer perimeter 48 at the distal-most end of the respective arms 41a and 41b. For instance, the first row 50a can contain double the number of fixation apertures of the second row 50b. In one example, the first row 50a can include first and second ones 38a and 38b of the fixation holes 38 of the first and second arms 41a and 41b, respectively. It should be appreciated, of course, that the first row 50a can include any number of fixation holes 38 as desired, arranged as desired.
The second row 50b of each of the first and second arms 41a and 41b can include likewise include any number of fixation holes 38 as desired. In one example, the second row 50b can include a respective one 38c of the fixation holes 38. The central hole axes of the fixation hole 38 of the second row 50b are spaced from the central hole axes of the fixation holes 38 of the first row 50a in the proximal direction. The respective one 38c of the fixation holes 38 of the second row 50b can be disposed between the first and second ones 38a and 38b of the fixation holes 38 of the first row 50a with respect to the lateral direction A.
The first and second ones 38a and 38b of the fixation holes 38 of the first rows 50a can be configured to receive bone screws that are driven into the lunate fossa and sigmoid notch. Bone screws inserted into the hole 38c can be aligned to be driven into the scaphoid fossa. Bone screws inserted into the hole 38d can be aligned to be driven into a styloid fragment. The fixation hole 38 of the second row 50b can be configured to receive a bone screw that is driven into the lunate fossa and sigmoid notch. Bone screws can be driven into hole 38f of the second row to reach and support a styloid fragment.
The variable angle locking hole 44 will now be described, with initial reference to
The fixation hole 38 is sized to receive the shaft 35 of the bone anchor 32. In particular, the fixation hole 38 has a cross-sectional dimension that is defined from one location of the internal surface 39 to another radially opposite location of the internal surface 39 along a straight linear direction that passes through the central hole axis 45 and is perpendicular to the central hole axis 45. In one example, the cross-sectional dimension defines a diameter of the internal surface 39. Thus, the internal surface 39 can extend along a circular path in cross-section along a plane that is oriented normal to the central hole axis 45. However, it is recognized that the internal surface 39 can define any suitable geometry as desired. The cross-sectional dimension is greater than the outer diameter of the at least one thread of the bone anchor shaft 35, such that the shaft 35 can travel through the variable angle locking hole 44 so as to extend out from the inner surface 34 and into the underlying bone.
The variable angle locking hole 44 can include the at least one thread 46 that is configured to threadedly mate with the threaded head 33 of the bone anchor 32. In particular, the at least one thread 46 can extend from at least a portion of the internal surface 39 into the fixation hole 38. In one example, the thread 46 can be monolithic with the internal surface 39. Because the at least one thread 46 is an internal at least one thread 46, the at least one thread 46 defines a major diameter at the interface between the at least one thread 46 and the internal surface 39. The at least one thread 46 can extend out from the internal surface to a minor diameter that is radially inwardly spaced from the major diameter. The minor diameter can be sized greater than the outer diameter of the at least one thread of the bone anchor shaft 35, such that the shaft 35 can travel through the variable angle locking hole 44 so as to extend out from the inner surface 34 and into the underlying bone. The radially inward direction, as used herein, can be defined as a direction toward the central hole axis 45. A radially outward direction is opposite the radially inward direction. Thus, the radially outward direction, as used herein, can be defined as a direction away from the central hole axis 45. A direction normal to the central hole axis 45 can be said to be radial direction.
In one embodiment, the at least one thread 46 extends along a portion of the axial length of the internal surface 39. Alternatively, the at least one thread 46 can extend along an entirety of the axial length of the internal surface 39. The at least one thread 46 can define a thread path that is sloped with respect to a reference plane. The reference plane can be normal to the central hole axis 45. Thus, the reference plane can be defined by the radial direction. The thread path can be defined by the minor diameter of the at least one thread 46 that defines the thread crest. In one example, the at least one thread 46 can be a helical thread. Thus, the thread path can define a helix. Further, the at least one thread 46 can define a single thread. Alternatively, the at least one thread 46 can include multiple threads. For instance, the at least one thread 46 can be configured as a double lead thread or alternative multiple lead thread.
The internal surface 39 defines an axially inner end 52 that can extend to the inner surface 34. The axially inner end 52 can define an edge that is shared by the inner surface 34. Alternatively, the axially inner end 52 can flare radially outward as it extends in the axially inward direction toward the inner surface 34. In one example, the axially inner end 52 flares radially outward as it extends in the axially inward direction. The axially inner end of the internal surface 39 can be defined by an undercut 56 that flares radially outward to the axially inner surface 34. For instance, the undercut 56 can flare linearly to the axially inner surface 34. Alternatively, at least a portion up to all of the undercut 56 can be curved as it extends to the axially inner surface 34. The undercut 56 can extend about an entirety of the perimeter of the variable angle locking hole 44. Further, the axially outer end of the undercut 56 can be defined by an edge that is defined by a radius of between approximately 0.75 mm and approximately 1.75 mm, such as between approximately 1 mm and approximately 1.5 mm, for instance approximately 1.4 mm. The edge can be interrupted by recesses 60 as described in more detail below.
The at least one thread 46 can extend radially inward from the inner surface 34 at the undercut 56. Alternatively, the undercut 56 can be devoid of threads, and can be substantially smooth. As will be appreciated from the description below, the undercut 56 can cause the internal surface 39 to avoid contact with the shaft 35 at angles between the central anchor axis 53 and the central hole axis 45 that would be prevented due to contact between the internal surface 39 and the shaft 35 without the undercut 56. Thus, the undercut 56 can widen the range of angles that are defined by the central anchor axis 53 and the central hole axis 45 at which the threaded head 33 is configured to threadedly mate with the at least one thread 46 in the fixation hole 38.
The internal surface 39 defines an axially outer end 54 that is opposite the axially inner end 52. The axially outer end 54 can extend to the outer surface 36. The axially outer end 54 can define an edge that is shared by the inner surface 34. As is described in more detail below, the axially outer end 54 can be defined by a second region 49 of the internal surface 39. The second region can be unthreaded. The second region 49 of the internal surface 39 can be concave with respect to a view in the radially outward direction from the central hole axis 45. The fixation hole 38 can be configured to receive the head of a compression screw, such that the head of the compression screw abuts the second region 49 and applies a compression force to the bone plate that urges the bone plate toward, for instance against, the underlying bone as the compression screw is driven into the underlying bone. It should be appreciated that the axially inward and axially outward directions can be oriented along the transverse direction T, or can define an angle with respect to the transverse direction T. For instance, the internal surface 39 can be tapered and extend along the axial direction that includes both the axially inward direction and the axially outward direction.
The at least one thread 46 can extend from a first location 46a to a second location 46b that is offset from the first location 46a along the axially outward direction. The at least one thread terminates at the first location 46a and the second location 46b. The first location 46a can extend to the inner end 52 of the internal surface 39. Thus, the first location 46a can extend to the inner surface 34. Alternatively, the first location 46a can be offset from the inner surface 34 along the axially outward direction. The second location 46a can extend to the outer end 54 of the internal surface 39. Thus, the first location 46a can extend to the second region 49 of the internal surface 39. Alternatively, the second location 46b can extend to the outer surface 36. Alternatively, the second location 46b can be offset from the outer surface 36 along the axially inward direction.
With continuing reference to
Opposed pairs of the columns 62 can be disposed radially opposite each other through the central hole axis 45. At least a portion up to an entirety of each of the recesses 60 can extend through the threaded region 47 at least to the internal surface 39 along the radially outward direction away from the central hole axis 45. For instance, at least a portion up to an entirety of each of the recesses can extend into the internal surface 39 along the radially outward direction away from the central hole axis 45. Thus, at least a portion up to an entirety of the recesses 60 can further extend radially outward through the at least one thread 46 that is carried by the internal surface 39. Each of the recesses 60 terminates radially at a respective recessed surface 61 of the plate body 31. Thus, it can be said that the recesses 60 can be at least partially or fully defined by the recessed surface 61. It can further be said that each recessed surface 61 defines a radial outer perimeter of the respective recesses 60. The recesses 60 can extend through the bone plate body 31 from the axially inner surface 34 to the axially outer surface 36. The recessed surface 61 of each of the recesses 60 between adjacent ones of the columns 62 can define any suitable surface area as desired. For instance, the surface area of the recessed surface 61 of each of the recesses 60 from the inner surface 34 to the outer surface 36 can be between approximately 32 mm and approximately 5 mm2, such as between approximately 4 mm2 and approximately 4.5 mm2, such as approximately 4.4 mm2. The terms “approximate” and “substantially” as used herein with respect to dimensions and shapes recognizes that manufacturing tolerances along with other factors, such as rounding, can cause variation in measurements and distances. Further, term “between” with respect to ranges of dimensions is used herein to also include the respective dimensions.
In one example, the plate body 31 can include four recesses 60 that are circumferentially spaced apart from each other. However, it is appreciated that the plate body 31 can include any number of recesses 60, greater than one, as desired, so as to define the variable angle locking hole 44 of the type described herein. Further, the circumferential distance of the recessed surfaces of each of the recesses 60 can be the same as each other along a common plane that is oriented normal to the central hole axis 45. In this regard, each of the recesses 60 can be sized and shaped substantially identical to each other. Further, the recesses 60 can be circumferentially equidistantly spaced from each other about the central hole axis 45. Alternatively, the recesses 60 can be circumferentially spaced from each other a variable distance about the central hole axis 45. Similarly, the plate body 31 can include four columns 62 of thread segments 64 that are circumferentially spaced apart from each other. However, it is appreciated that the plate body 31 can include any number of columns 62, greater than one, as desired, so as to define the variable angle locking hole 44 of the type described herein. The columns 62 can be sized and shaped substantially identical to each other. Further, the columns 62 can be circumferentially equidistantly spaced from each other about the central hole axis 45. Alternatively, the columns 62 can be circumferentially spaced from each other a variable distance about the central hole axis 45.
The recesses 60 can have a radial depth sufficient such that the recessed surface 61 is recessed with respect to the internal surface 39 along the radially outward direction. That is, the recessed surface 61 can define a radial distance from the central hole axis 45 that is greater than the radial distance from the central hole axis 45 to the major diameter of the at least one thread 46. Further, an entirety of the recessed surface 61 can define a curvature along a plane that is oriented normal to the central hole axis 45 from a first end of the recessed surface 61 that adjoins the internal surface 39 of one of the columns 62 to a second end of the recessed surface 61 that adjoins the internal surface 39 at another one of the columns 62. The curvature can be a constant curvature from the first end to the second end. In one example, the recessed surface 61 extends along a circular path along the plane that is oriented normal to the central hole axis 45.
The recesses 60 further extend in the axially outer direction defined from the axially inner surface 34 toward the outer surface 36. In one example, each of the recesses 60 can extend from a respective axially first or inner terminal end to a respective opposed axially second or outer terminal end. The inner terminal end can be disposed at the axially inner surface 34. Alternatively or additionally, depending on the size of the undercut 56, the inner terminal end can extend into the undercut 56. Alternatively still, the inner terminal end of the recesses 60 can be circumferentially aligned with the inner terminal end of the columns 62. The undercut 56 can be localized at a location aligned with the columns 62 so as to not extend circumferentially beyond the column 62. Alternatively, the undercut 56 can extend about the entire perimeter of the variable angle locking hole 44. The outer terminal ends of the recesses 60 can be spaced axially inward from the axially outer surface 36. Alternatively, as illustrated in
The axially outer surface 36 can define an opening 29 of the variable angle locking hole 44. The opening 29 thus has an outer perimeter that is defined by the axially outer surface 36 of the bone plate 30. The axially outer surface 36 at the opening 29 can be defined entirely by the internal surface 39. The recessed surfaces 61 of each of the recesses 60, in their respective entireties, can be offset from the outer perimeter of the opening 29 in the radially inward direction, that is toward the central hole axis 45. Thus, the axially outer surface 36 at the opening 29 can define a circle. It should be appreciated, of course, that the axially outer surface 36 at the opening 29 can define any suitable alternative shape as desired. For instance, as illustrated in
Adjacent ones of the columns 62 can be separated by a common one of the recesses 60. The adjacent ones of the columns 62 can be referred to as circumferentially adjacent ones of the columns 62. The columns 62 and recesses 60 can define circumferential centerlines that extend along planes that intersect the central hole axis 45. The circumferential centerlines of the columns can be circumferentially offset from circumferential centerlines of the recesses 60 by 45 degrees. Each of the columns 62 includes a plurality of thread segments 64. The thread segments 64 can be defined by the least one thread 46 that is divided into the thread segments 64 by the recesses 60. Thus, circumferentially adjacent ones of the columns 62 of thread segments are separated from each other by a respective one of the recesses 60. The thread segments 64 of each of the columns 62 can be discontinuous with respect to the thread segments 64 of the other ones of the columns 62 at the recesses 60. Thus, each of the recesses 60 interrupts the at least one thread 46 and divides the at least one thread 46 into the corresponding plurality of thread segments 64.
The thread segments 64 of each of the columns 62 can thus be circumferentially offset from the thread segments 64 of the other ones of the columns 62. Further, adjacent ones of the circumferentially spaced thread segments 64 can be separated by a common one of the recesses 60. Thus at least one or more of the thread segments 64 up to all of the thread segments 64 are aligned with at least one other of the thread segments 64 of an adjacent one of the columns 62 along the thread path. For instance, at least one or more of the thread segments 64 up to all of the thread segments 64 are aligned with at least one other of the thread segments 64 of an adjacent one of the columns 62 along a helical path. In one example, each of a plurality of the thread segments 64 of a respective one of the columns 62 is aligned along the thread path with 1) a first one the thread segments 64 of a first other one of the columns 62 that is adjacent the respective one of the columns 62 along a first circumferential direction, and 2) a second one the thread segments 64 of a second other one of the columns 62 that is adjacent the respective one of the columns 62 along a second circumferential direction that is opposite the first circumferential direction. Thus, the respective one of the columns 62 is disposed circumferentially between the first other one of the columns and the second other one of the columns. Further, the thread segments 64 of the respective one of the columns 62 is disposed between the first one of the thread segments 64 and the second one of the thread segments 64 with respect to the transverse direction T.
Each of the columns 62 can define a circumferential length in a respective plane oriented normal to the central hole axis 45. The circumferential length of each of the columns 62 can decrease in the radially inward direction. The thread segments 64 of each of the columns 62 are offset from each other along the transverse direction T. Further, each of the thread segments 64 defines first and second circumferentially opposed terminal ends. Each of the thread segments 64 defines a respective circumferential length from the first circumferentially terminal end to the second circumferentially terminal end. The circumferential lengths can be measured at the crests of the thread segments 64, which can be defined by the minor diameter. In one example, the circumferential lengths of the thread segments 64 decrease in the axially inward direction. In particular, the columns 62 define at least three consecutive ones of the thread segments 64 whose circumferential lengths decrease in the axially inward direction. It can thus also be said that the circumferential lengths of the at least three consecutive ones of the thread segments 64 increase in the axially outward direction. Thus, the axially outermost one of the thread segments 64 of each of the columns has a circumferential length greater than the axially innermost one of the thread segments 64 of each of the columns. The undercut 56 can be devoid of threads and smooth. Alternatively, the undercut 56 can define at least one thread segment 64 that is consecutive with an axially innermost one of the thread segments 64 of the each of the columns 62 along the thread path.
The circumferential lengths of the thread segments 64 of each of the columns 62 can decrease at a constant rate in the axially inward direction. Thus, the columns 62 of thread segments 64 can be conically tapered. Alternatively, the circumferential lengths of the thread segments 64 of each of the columns 62 can decrease at an increasing rate in the axially inward direction. Alternatively still, the circumferential lengths of the thread segments 64 of each of the columns 62 can decrease at a decreasing rate in the axially inward direction.
The columns 62 of thread segments 64 are each positioned so as to purchase with the threaded head 33 of the bone anchor 32 when the central anchor axis 53 of the bone anchor 32 is at an orientation with respect to the central hole axis 45 within a range of orientations at which the threaded head 33 is configured to mate with a plurality of the thread segments 64 of at least two of the columns 62. In one of the orientations within the range of orientations, the central anchor axis 53 can define an angle with the central hole axis 45 are within the range of angles in which the threaded head 33 is configured to threadedly mate with the at least one thread 46 in the fixation hole 38. In particular, the threaded head is configured to threadedly mate with at least a portion of at least two of the columns 62 when the bone anchor 32 is oriented such that the angle defined by the central anchor axis 53 and the hole axis 45 are within the range of angles. In one of the orientations within the range of orientations, the central anchor axis 53 can be coincident with the central hole axis 45.
The plate body 31, and thus the plate 30, can define at least one step 58 that project radially outward with respect to the internal surface 39 at the columns 62. For instance, the steps 58 can project radially outward from the internal surface 39 at the columns 62. The steps 58 can be oriented along a plane that is sloped with respect to a plane that is oriented normal to the central hole axis 45. For instance, each of the steps 58 can extend in the axially inward direction as it extends in the radially inward direction. Alternatively, the steps 58 can be oriented along a plane that is oriented normal to the central hole axis 45. Thus, it should be appreciated that the steps 58 can be oriented along any suitable direction as desired.
The steps 58 can separate the internal surface 39 at the columns 62 from the second region 49. The recesses 60 can separate circumferentially adjacent steps 58 from each other. Thus, the outer axial ends of the recessed surfaces 61 can extend circumferentially between adjacent steps 58. Alternatively, the recesses 60 can terminate axially inward of the steps 58, such that the steps 58 extend circumferentially continuously between the second region 49 and both the columns 62 and the recessed surfaces 61. Further, the outer surface 36 at the perimeter of the opening 29 can be defined by the second region 49 of the internal surface 39.
As described above, the internal surface 39 can define the second region 49 that extends between the axially outer surface 36 and both the columns 62 and the recessed surfaces 61. In one example, the second region 49 can extend from the axially outer surface 36 to the columns 62 and the recessed surfaces 61. Thus, locations of the second region 49 can be inline with respective ones of the columns 62 with respect to the transverse direction along respective planes that include the central hole axis 45, and other locations of the second region 49 can be inline with respective ones of the recessed surfaces 61 along respective planes that include the central hole axis 45. Thus, the axially outer end 54 of the inner surface 39 can be defined by the second region 49. It should be appreciated that the internal surface 39 at the columns 62 can be offset in the radially inward direction from the second region 49. That is, the internal surface 39 at the columns 62 can be disposed between the second region 49 and the central hole axis 45 with respect to the radial direction. The second region 49 can be circumferentially continuous and uninterrupted along an entire revolution along a constant curvature about the central hole axis along a plane that is oriented perpendicular to the central hole axis.
The second region 49 can be tapered radially inwardly as it extends in the axially inward direction. For instance, the second region 49 can be tapered radially inwardly from the axially outer surface 36 to the step 58. In one example, the second region 49 can be curved as it extends in the inward direction. For instance, the second region 49 can be concave as it extends along both a plane that includes the central hole axis, and a plane that is oriented perpendicular with respect to the central hole axis. Thus, the second region 49 can be concave along both the circumferential direction and the axial direction with respect to a view from inside the fixation hole 38. For example, the second region 49 can be dish shaped. The curvature of the second region 49 can be greater as it extends in the axial direction than the curvature of the second region 49 as it extends in the circumferential direction. The curvature of the second region 49 in the circumferential direction can be constant. Alternatively or additionally, the curvature of the second region 49 in the axial direction can be constant. In one example, the second region 49 can be spherical as it extends radially inwardly from its outer axial end to its inner axial end. The second region 49 can be unthreaded and smooth along its entirety. Alternatively, it is recognized that the second region 49 can define various textures as desired that are configured to abut the head of a compression screw in the manner described above. Thus, it can be said that the second region 49 can be devoid of threads configured to purchase with a threaded screw head.
The axially outer ends of the columns 62 can extend to the step 58. The steps 58 can be disposed between adjacent ones of the recesses 60 with respect to the circumferential direction. Thus, the steps 58 can be aligned with the columns 62 with respect to the transverse direction T. Thus, the columns 62 can extend from the step 58 to the axially inner surface 34. Alternatively, the columns 62 can extend from the step 58 to the undercut 56. Further, each of the steps 58 can be circumferentially tapered inwardly as it extends radially inwardly from a radially outer end to a radially inner end. The steps 58 can adjoin to the second 49 region at the radially outer end.
Further, at least a portion up to all of the internal surface 39 at each of the columns 62 can be tapered radially inwardly along its length as it extends in the axially inward direction. For instance, the internal surface 39 defines a respective region 63 that is tapered from its axially outer end to the undercut 56, or alternatively to the axially inner surface 34 of the undercut 56 is not present. The region 63 can be referred to as tapered threaded regions. The tapered threaded region 63 can include the plurality of columns 62 in the manner described above. The tapered threaded region 63 can be conical or alternatively shaped as desired. The tapered threaded region 63 can define an axially outer end and an axially inner end. The axially outer end of the tapered threaded region 63 can terminate at respective ones of the steps 58.
The second region 49 can extend between the outer surface 36 and both the steps 58 and the recessed surfaces 61. That is, the second region 49 can be bound at its axially inner end by the steps 58 and the recessed surfaces 61. The second region can be bound at its axially outer end by the outer surface 36. Alternatively, if the bone plate 30 does not include the steps 58, the second region 49 can extend between the outer surface 36 and both the steps 58 and the recessed surfaces 61. That is, the second region 49 can be bound at its axially inner end by the steps 58 and the recessed surfaces 61 the second region 49 can be bound at its axially inner end by the columns 62 and the recessed surfaces 61. Thus, if the bone plate 30 does not include the steps 58, the axially outer end of the tapered threaded region 63 can terminate at their respective axially outer ends at the second region 49. Thus, the second region 49 can extend axially outward from the second region 49.
Alternatively still, if the bone plate 30 does not include the second region 49 as illustrated in
The internal surface 39 at the radially innermost edge of the step 58 can define a constant curvature along its circumferential length along a plane that is oriented normal to the central hole axis 45. The constant curvature can, for instance, extend along a circular path. The recessed surfaces 61 can similarly define a constant circumferential curvature along the same plane that is oriented normal to the central hole axis 45. The circumferential curvature of the recessed surfaces 61 can be greater than the circumferential curvature of the step 58. Thus, the circumferential curvature of the step 58 can be defined by a first radius, and the circumferential curvature of the recessed surface 61 can be defined by a second radius that is less than the first radius. The step 58 can be defined by a radially outermost edge opposite the radially innermost edge. The radially outermost edge of the step can have a total circumferential length of between 6 mm and 10 mm, for instance between approximately 7 mm and approximately 9 mm, for instance approximately 8.8 mm.
The first and second ends of an entirety of the recessed surface 61 at each axial location the respective recess 60 can diverge away from each other as they adjoin the internal surface 39. Further, a straight line that extends from the first end of the recessed surface 61 to the second end of the recessed surface 61 at every axial location of the recesses 60 can define a chord of a circle that defines the circular path of the recessed surface 61. The chord can be disposed between the center of the circle and the recessed surface 61. Thus, the first and second ends of the recessed surface define a circumferential length that is less than or equal to (e.g, no more than) 180 degrees of the circle that defines the circular path of the recessed surface 61 along a plane that is normal to the central hole axis 45, along an entirety of each of the recesses 60. For instance, the straight line can alternatively define the diameter of the circle. The circumferential length of the recessed surface 61 can decrease along the axially outward direction. For instance, the recessed surface 61 can define a minor arc along the plane from the first end of the recessed surface 61 to the second end of the recessed surface 61, along an entirety each of the recesses 60. The recessed surface 61 defines a curvature in the circumferential direction that is greater than the curvature of the internal surface 39 at the columns 62 along a common plane that is oriented perpendicular to the central hole axis 45.
The recesses 60 can be oriented in any direction as desired. For instance, the recessed surfaces 61 can each be radially outwardly sloped with respect to the central hole axis 45 as it extends along the axially outward direction. Alternatively, the recessed surfaces 61 can be spaced from the central hole axis 45 a constant distance along an entirety of their axial length along a plane that includes the central hole axis 45. Further, the circumferential length of the recessed surface 61 can increase as the recessed surface 61 extends in the axially inward direction along a respective plane that 1) is oriented normal to the central hole axis 45 and 2) is disposed at a location whereby it further extends into the columns 62.
The undercut 56 can extend radially out from the axially inner end of the tapered threaded region 63 of the internal surface 39. Further, the undercut 56 can carry a portion of the at least one thread 46, and thus can define a portion of the columns 62. Alternatively, the undercut 56 can be devoid of threads. In one example, one or both of the step 58 and the second region 49 of the internal surface 39 can be devoid of threads that are designed to purchase with the threaded head 33 of the bone anchor 32. Thus, one or both of the step 58 and the second region 49 of the internal surface 39 can be said to be substantially smooth.
The internal surface 39 at each of the columns 62 from the axially outer end of the column to the axially inner end of the column 62 can define any suitable surface area as desired. For instance, the columns 62 can cumulatively define a surface area that is between approximately 3 mm2 and approximately 6 mm2, such as between approximately 4 mm2 and approximately 5 mm2, and in one example can be approximately 4.2 mm2. The axially outer edge of at least one of the columns, up to all of the columns 62, can have a first circumferential length, and the axially inner edge of at least one of the columns, up to all of the columns 62, can have a second circumferential length that is between approximately 45% and approximately 90% of the first circumferential length. For instance, the second circumferential length can be between approximately 60% and approximately 80% of the first circumferential length. In one example, the second circumferential length can be between approximately 75% and 80% of the first circumferential length. For example, the first circumferential length can be approximately 77% of the first circumferential length. The first circumferential length can be between approximately 0.75 mm and approximately 2.5 mm, such as between approximately 1 mm and approximately 2 mm, for instance approximately 1.5 mm. The second circumferential length can be between approximately 0.5 mm and approximately 2 mm, such as between approximately 0.75 mm and approximately 1.5 mm, for instance approximately 1.2 mm.
Fabrication of the bone plate 30 can include the step of creating a through-hole through the bone plate body 31 from the axially outer surface 36 to the axially inner surface 34. The creating step can, for instance, include the step of creating the through-hole through the bone plate body 31 so as to define an interior surface of the bone plate body 31. The through-hole can be created such that the interior surface of the bone plate body tapers radially inward toward the central hole axis 45 as it extends in the axially inward direction, as described above. The creating step can, in one example, include the step of drilling the through-hole through the bone plate body 31. The drilling step can be performed in a single step, or in multiple steps of creating a through-hole, and then defining the through-hole to have a conical shape. Further, the drilling step can include the step of creating a counterbore so as to define the step 58 and the corresponding second region 49 as described above. However, as recognized from the description below, the bone plate 30 can be devoid of the step 58, such that the internal surface 39 defines the columns 62 and not the second region 49. Thus, the step of creating a counterbore can define the second region 49 without defining the step 58. Accordingly, the internal surface 39 can define a constant taper from the axially outer surface 36 to the undercut 56, or to the axially inner surface 34 if the bone plate 30 does not include the undercut. The method can further include the step of creating the undercut 56 at the axially inner surface 34. The undercut 56 can be created during the step of creating the through-hole, or after the through-hole has been created.
Next, the method can include the step of cutting the at least one thread 46 into the interior surface so as to define the internal surface 39 and the at least one thread 46. It should be appreciated that the minor diameter of the at least one thread 46 can be defined by the crest of the at least one thread, and the major diameter of the at least one thread can be defined by the internal surface 39. The at least one thread 46 can define a height from the minor diameter to the major diameter along its length. In one example, the height can be constant along at least a plurality of revolutions of the at least one thread 46 about the central hole axis 45. Thus, the minor diameter of the thread can lie on a conical geometric shape. In another example, the height can increase or decrease along the length of the at least one thread 46 as the at least one thread 46 extends in the axially inward direction. The method can include the step of creating the recesses 60 in the internal surface 39. The step of creating the recesses 60 can similarly create the columns 62. Thus, the step of creating the recesses 60 can be performed after the at least one thread is formed 46. Alternatively, the step of creating the recesses 60 can be performed prior to forming the at least one thread 46. The recesses 60 can be created in the interior surface to define the columns 62, and the at least one thread 46 can then be created in the columns 62 so as to define the interior surface 39 and the at least one thread. Because the recessed surfaces 61 are curved along an entirety of their length along a plane oriented normal to the central hole axis 45, the step of creating the recesses 60 can be achieved by drilling into the bone plate 30 along at least a portion of the internal surface 39 or the interior surface. Thus, each of the recesses 60 defines a circumferential end that is open at the internal surface 39. In one example, each of the recesses 60 can be drilled into the axially inner surface 34 along the axially inward direction, such that the inner end of the recesses 60 have a radial depth that increases as the recesses 60 extend in the axially outward direction. The radial depth of the recesses 60 can be selected so as to define the columns 62 of thread segments 64 as described above.
The bone plate body 31 can define a height along the transverse direction T from the axially inner surface 34 to the axially outer surface 36. The bone plate body 31 can define a height from the axially outer edge of the undercut 56 to the second region between approximately 0.9 mm and approximately 3.0 mm, such as approximately 2.25 mm. The bone plate body 31 can have a height from the axially inner surface 34 to the axially outer end of the columns 62 (and thus the tapered threaded region 63) of between approximately 0.75 mm and approximately 2 mm, such as between approximately 1 mm and approximately 1.5 mm, such as approximately 1.3 mm. The height of each of the columns 62 can be from the axially outer edge of the undercut 56 (or the axially inner surface 34 if the undercut 56 is not included) and the axially outer edge of the columns 62 of between approximately 0.7 mm and approximately 1.3 mm, such as approximately 1.2 mm.
A method of bone fixation using the bone fixation system 20 will now be described with further reference to
Continuing rotation of the bone anchor 32 while the angle defined by the central anchor axis 53 and the central hole axis 45 is in the range of angles causes the threaded head 33 to advance into the variable angle locking hole 44, such that the threaded head 33 threadedly mates with the at least one thread 46 of the variable angle locking hole 44. For instance, a portion of the threaded head 33 can threadedly mate with the at least one thread at a plurality, e.g., at least two, of the columns 62. It is recognized that different angles between the central anchor axis 53 and the central hole axis 45 will cause the threaded head 33 to threadedly purchase with different locations of the at least one thread 46 with respect to the transverse direction T.
A compression screw can be inserted through a second one of the fixation holes 38, until 1) the shaft of the compression screw is threadedly driven into underlying bone, and 2) the head of the compression screw bears against the second region 49 to apply a compression force against the bone plate toward the underlying bone.
Without being bound by theory, it is believed that the recesses 60 assist in the ability of the bone anchor 32 to angulate with respect to the central hole axis 45 within the range of angles while threadedly purchasing with the at least one thread 46. Further, without being bound by theory, it is believed that the ability of the threaded head 33 to threadedly purchase with the columns 62 of thread segments 64 can provide more reliable fixation than conventional variable angle locking holes.
Referring now to
Without being bound by theory, it is believed that removing the second region 49 allows the bone plate 30 to have a decreased height with respect to conventional variable angle bone plates while exhibiting reliable purchase between the threaded screw head 33 and the bone plate 30 in the variable angle locking hole 44. Thus, in one example, the height of the bone plate 30 from the axially inner surface 34 to the axially outer surface 36 along the transverse direction T can be between approximately 0.75 mm and approximately 2 mm, such as between approximately 1 mm and approximately 1.5 mm, such as approximately 1.3 mm.
The embodiments described in connection with the illustrated embodiments have been presented by way of illustration, and the present invention is therefore not intended to be limited to the disclosed embodiments. Accordingly, those skilled in the art will realize that the invention is intended to encompass all modifications and alternative arrangements included within the spirit and scope of the invention, as set forth by the appended claims.
This claims priority to U.S. Patent Application Ser. No. 62/385,107 filed on Sep. 8, 2016, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.
| Number | Date | Country | |
|---|---|---|---|
| 62385107 | Sep 2016 | US |
