This disclosure relates to bone plates and methods for fixating bones using a bone plate, including compressing opposed bone ends together using a bone plate.
Bones, such as the bones of a foot, may be anatomically misaligned. In certain circumstances, surgical intervention is required to correctly align the bones to reduce patient discomfort and improve patient quality of life. Surgical intervention may involve cutting one or more of the misaligned bones and then physically realigning the bones into an anatomically corrected position. A bone plate or multiple bone plates may be used to hold the bones in the anatomically corrected position, helping to prevent the bones from shifting back to their misaligned position.
In general, this disclosure is directed to bone plates and screws, systems incorporating bone plates and screws, and methods of using bone plates. In some examples, bone plate systems and techniques are described to facilitate compression (e.g., angular compression) between opposed ends of two bone portions to which a bone plate is attached, which may be different portions of the same bone or two different bones separated by a joint. The force generated by the plating system may be asymmetrically distributed across the faces of the bone ends being pressed together, e.g., such that there is a greater force on a side of the bone ends opposite the plate than on a side of the bone ends closer to the plate. This may help facilitate angular correction of the bone portions relative to each other and/or promote healing (e.g., fusion) between the bone portions in a corrective orientation.
In some implementations, a bone plate includes an elongated body having a length greater than a maximum width and thickness. For example, the bone plate may have a length sized to span a tarsometatarsal joint separating a metatarsal from an opposed cuneiform. The bone plate may include a bend that displaces a portion of the bone plate positionable over the joint between the two bone portions away from the joint. As a result, the bone plate may include a first end contacting one bone portion and a second end contacting the second bone portion, with an intermediate portion between the two ends displaced off of one or both bone portions and/or the joint between the two bone portions.
To secure the bone plate to the bone portions, the bone plate can include multiple fixation holes extending through the bone plate, including at least one fixation hole positionable over the first bone portion and at least one additional fixation hole positionable over the second bone portion. One or more of these fixation holes may include threading partially or fully encircling the fixation hole to facilitate engagement with threading on the head of a locking screw insertable through the fixation hole and into an underlying bone.
To both secure the locking plate to an underlying bone portion and achieve compression between the ends of the two bone portions being secured together with the bone plate according to some examples, at least one locking screw may be used that is configured to both interlock with the bone plate and deform the bone plate when driven beyond its initially engaged position in the bone plate. For example, as an arch in the bone plate is physically deformed toward a flattened or unbent profile (e.g., resulting in a residual arch of smaller height after deformation), an underside of the plate may be placed in tension and a topside of the plate placed in compression. As a result, a moment force may be applied that has an asymmetrically distributed magnitude across the end faces of the bones being compressed. When used, the locking screw may be configured to interlock with the bone plate and deform the bone plate by controlling the compression ratio of the locking screw. The compression ratio of the bone screw may be controlled by adjusting the pitch of the threading on the head of the screw relative to the pitch of the threading on the shaft of the screw and/or by controlling the lead of the head relative to the lead of the shaft.
Traditional bone plate systems utilize one of two different types of screws: compression screws or locking screws. Compression screws are screws that have a threaded shaft but do not have a threaded head. In use, a compression screw can be driven until the head of the screw contacts the bone plate and then further driven into the bone to compress the bone plate. By contrast, locking screws have both a threaded head and a threaded shaft. However, locking screws are generally designed to be screwed until the threaded head is interlocked with the counter threading on the bone plate without causing any compression on the bone plate.
In accordance with some examples of the present disclosure, a bone plate is provided with one or more locking screws that achieve both interlocking between the head of the screw and the counter threading around the fixation hole on the bone plate as well compression of the bone plate during rotation. The pitch of the threading on the shaft of the screw may be sufficiently greater than the pitch of the threading on the head of the screw to achieve both interlocking and compression. Additionally or alternatively, the lead of the threading on the shaft may be greater than the lead of the threading on the head to generate a compressive force as the locking screw is inserting into an underlying bone. In either case, as the threading on the head of the screw rotationally interlocks with the counter threading around the fixation hole, the threading on the shaft may continue to draw the bone plate engaged with the threading on the head down toward the bone. As a result, a bend in the bone plate may deform (e.g., elastically and/or plastically) toward the bone portions being fixated.
In some examples, the bone plate is provided with the one or more locking screws configured for both interlocking with the bone plate and for compression. The bone plate has a bend portion. The bend portion may be a region of the bone plate between opposed ends of the bone plate that is non-planar with one or both end portions (e.g., prior to deformation and/or installation). The bend portion may be offset from the end portions in one or more planes. For example, when one end of the bone plate is positioned in contact with one bone portion and the second end of the bone plate is positioned in contact with the other bone portion, the bend portion may define a gap between a bone-facing surface of the bone plate in the bend portion and the surfaces of the underlying bone(s). This gap may be reduced or eliminated through flattening of the bend upon installation of the one or more locking screws that are also configured to achieve compression.
With the bend portion of the bone plate positioned over the joint between the two bone portions to be fixated together, one or more locking screws configured for compression may be installed through corresponding fixation holes in the bone plate and into underlying bone. As the one or more locking screws are installed, the bend portion in the bone plate may deform toward the joint between the two bone portions. With the bone plate deformed from an initial bend to a reduced bend profile, the bone plate may function as a spring providing a distributed load through the end faces of the bones being pressed together, e.g., with a greater force on the cortex of the bones on an opposite the plate than the force on the cortex of the bones closest to the plate. As a result, the force provided by the tensioned bone plate may be angular, e.g., helping to reinforce a bone realignment performed prior to fixation using the bone plate.
In some examples, a bone plate with a bend portion may be positioned over a joint between two adjacent bone portions to be fixated and one or more locking screws configured for compression installed through the fixation holes of the bone plate into the underlying bone portions. One or more additional screws (e.g., compression screws, locking screws not configured for compression) may also be installed through one or more fixation holes of the bone plate into one or more underlying bone portions.
Additionally or alternatively, one or more driving pins may be used to help install and pre-compress the bone plate prior to installation of the screws. When used, a driving pin may include a threaded head, a shaft, and an enlarged region having a cross-sectional area larger than a cross-sectional area of the fixation hole through which the head of driving pin is to be inserted. One or more driving pins can be installed through the fixation holes of the bone plate into the underlying bone portions, e.g., by screwing the distal head of the one or more driving pins into the underlying bone portions. As the driving pin(s) are driven deeper into the underlying bone portion(s), the enlarged region of the driving pin can press against a top surface of the bone plate adjacent a corresponding fixation hole. This can cause the bone plate to compress toward the bone portions being fixated. One or more individual driving pins can then be removed and corresponding screws installed to complete the installation process.
In yet additional examples, a bone plate with a bend portion may be pre-deformed (e.g., pre-compressed) before or concurrent with being positioned over a joint between two adjacent bone portions to be fixated (and prior to installation of any screws or, optionally, driving pins). For example, using hand manipulation and/or a bending instrument, the bend portion of the plate may be compressed toward a more planar shape and held in compression while placed spanning the joint between the bone portions being fixated. The bone screws and/or driving pins can then be installed through the fixation holes of the bone plate while held in compression. One example bending instrument that may be used is a pair of plate bending arms inserted through fixation holes on opposite sides of the apex of the bend portion (e.g., into drill guides installed in the fixation holes), which are then used to manipulate the bone plate.
In one example, a method of applying a bone plate across a tarsometatarsal joint is described. The method includes positioning a bone plate across a tarsometatarsal joint separating a metatarsal from a cuneiform. The bone plate has a first fixation hole, a second fixation hole, and a bend between the first fixation hole and the second fixation hole. Positioning the bone plate across the tarsometatarsal joint involves positioning the bend over the tarsometatarsal joint with a gap between a bone-facing surface of the bone plate and the tarsometatarsal joint. The method also involves inserting a locking screw through the first fixation hole. The locking screw has a head with a head thread and a shaft with a shaft thread. The shaft thread has a pitch greater than a pitch of the head thread, and the first fixation hole includes threading for engaging with the head thread. The method involves screwing the locking screw into a metatarsal or a cuneiform under the first fixation hole until the head thread of the locking screw is engaged with the threading defined by the first fixation hole and further screwing the locking screw into the metatarsal or the cuneiform, thereby deforming the bend in the bone plate toward the tarsometatarsal joint.
In another example, an orthopedic fixation system is described. The system includes a bone plate having a length defining a longitudinal axis extending from a proximal end of the body to a distal end of the body. The bone plate has a top surface and a bone-facing surface opposite the top surface and includes a first fixation hole extending through the body and a second fixation hole extending through the body. The length of the bone plate is sized to cross a tarsometatarsal joint with one of the first fixation hole and the second fixation hole positioned over a metatarsal and an other of the first fixation hole and the second fixation hole positioned of a cuneiform. At least the first fixation hole includes threading, and the bone plate includes a bend offsetting a portion of the bone plate between the first fixation hole and the second fixation hole relative portions of the bone plate defining the first fixation hole and the second fixation hole. The system also includes a locking screw having a head with a head thread and a shaft with a shaft thread, the shaft thread having a pitch greater than a pitch of the head thread. The locking screw exhibits a compression ratio defined by the pitch of the shaft thread divided by the pitch of the head thread. The locking screw is configured to be inserted through the first fixation hole into at least one of the metatarsal and the cuneiform and the head thread engaged with the threading defined by the first fixation hole. The compression ratio is effective to cause the bone plate to deform when the head thread is fully engaged with the threading defined by the first fixation hole and the screw is further turned.
In another example, a method is described that includes tensioning a bone plate having a first fixation hole, a second fixation hole, and a bend between the first fixation hole and the second fixation hole by bending the bone plate against the bend toward a flattened profile, thereby providing a tensioned bone plate. The method includes positioning the tensioned bone plate across a tarsometatarsal joint separating a metatarsal from a cuneiform and inserting a locking screw through the first fixation hole. The locking screw has a head with a head thread and a shaft with a shaft thread. The shaft thread having a pitch greater than a pitch of the head thread, and the first fixation hole includes threading for engaging with the head thread. The method also includes screwing the locking screw into the metatarsal or the cuneiform under the first fixation hole until the head thread of the locking screw is engaged with the threading defined by the first fixation hole.
The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
The present disclosure is generally directed to bone plates, systems and kits that include one or multiple bone plates and screws, and method of using one or multiple bone plates and corresponding screws. In an exemplary application, a bone plate and screw system according to the disclosure can be useful for internal fixation of a bone or bones during a surgical procedure, such as a bone alignment, osteotomy, fusion procedure, fracture repair, and/or other procedures where one or more bones are to be set in a desired position. Such a procedure can be performed, for example, on bones (e.g., adjacent bones separated by a joint or different portions of a single bone) in the foot or hand, where bones are relatively small compared to bones in other parts of the human anatomy. In one example, a procedure utilizing an embodiment of the bone plate and screw system can be performed to correct an alignment between a metatarsal (e.g. a first metatarsal) and a cuneiform (e.g., a medial cuneiform), such as a bunion correction. An example of such a procedure is a lapidus procedure. In another example, the procedure can be performed by modifying an alignment of a metatarsal (e.g. a first metatarsal). An example of such a procedure is a basilar metatarsal osteotomy procedure.
Example screw configurations and methods of installing bone plate and screw systems according to the disclosure will be described in greater detail with respect to
Body 12 of bone plate 10 can define a distal region 20 at or near a first terminal end 22 and a proximal region 24 at or near a second terminal end 26 that is opposite the first terminal end of the body. The distal region 20 may be separated from the proximal region 24 by an intermediate region 28. For example, bone plate 10 may include one or more fixation holes extending through the thickness of body 12. In these examples, body 12 may include one or more fixation holes in distal region 20, one or more additional fixation holes in proximal region 24, and an intermediate region 28 devoid of fixation holes positioned between the distal region 20 and the proximal region 24.
In the illustrated example of
Each feature described as a fixation hole may be an opening extending through the thickness of body 12 that is sized to receive a corresponding screw. Each fixation hole may typically have a circular cross-sectional shape although may have other cross-sectional shapes without departing from the scope of the disclosure. The fixation hole may extend perpendicularly through the thickness of body 12 or may taper (e.g., such that the hole is larger adjacent top surface 16 than adjacent bone-facing surface 18). In still other examples, the fixation hole may extend at a non-perpendicular angle through the thickness of body 12 and/or be configured for polyaxial screw alignment.
Although bone plate 10 is illustrated as being configured with four fixation holes 30, 32, 34, and 36, the bone plate may include fewer fixation holes or more fixation holes. For example, distal region 20 and proximal region 24 of bone plate 10 may each include fewer fixation holes (e.g., one) and/or more fixation holes (e.g., three, four). The dimensions (e.g., length) of the distal and proximal regions 20, 24 can be adjusted to accommodate the particular number of fixation holes included. Further, while the fixation holes on bone plate 10 are illustrated as being co-axial with each other along the longitudinal axis 14 of the bone plate, the bone plate may include one or more branches each containing a fixation hole extend off of the longitudinal axis. As a result, the one or more fixation holes in these branch(es) may be non-co-linear with the remaining co-axially arranged fixation holes. For instance, in various examples, bone plate 10 may include at least one branch extending outwardly from the longitudinal axis 14 of the bone plate to define at least one of a Y-shape, an L-shape, a T-shape, a U-shape, and/or other shape profile.
Bone plate 10 may include a bend 40. Bend 40 may be a portion of bone plate 10 that is out of plane with one or more planes in which first fixation hole 30 and second fixation hole 34 are positioned. In some examples, first terminal end 22 and second terminal end 26 of bone plate 10 are coplanar (e.g., such that the terminal ends of the bone plate can be positioned in the same plane). Bend 40 may offset at least a portion of bone plate 10 out of the plane in which first terminal end 22 and second terminal end 26 are positioned.
As will be described, when bone plate 10 containing bend 40 is positioned across a joint between two bone portions, at least part of distal region 20 (e.g., including first terminal end 22) may contact one bone portion and at least part of proximal region 24 (e.g., including second terminal end 26) may contact the other bone portion. Bend 40 may elevate a portion of bone plate 10 off of the surface of one or both bone portions across the joint. As a result, a gap may exist between bone-facing surface 18 of bone plate 10 in the region of the bend and the underlying bone portions. The size of this gap may be reduced (optionally without eliminating the gap) upon insertion of one or more screws and/or compression of the bone plate.
Bend 40 of bone plate 10 may curve distal region 20 toward proximal region 24 about intermediate region 28. For example, bend 40 can reduce the distance between first terminal end 22 and second terminal end 26 as compared to when body 12 is flat or planar. Bend 40 can be defined by a sharp transition (e.g., V-shape) or a radius of curvature. The radius of bend 40 can vary or be constant as a function of longitudinal position on body 12, and/or be concentrated in one or more portions of the body, such as the portion of the body between the proximal and distal regions 20, 24. In some examples, bend 40 is defined by a radius of curvature ranging from approximately 10° to approximately 45°, such as from approximately 15° to approximately 35°. In other examples, bend 40 may be defined by a radius of curvature ranges from 45° to 135°, such as from approximately 75° to approximately 105°. Other angles of bend are also possible.
When bone plate 10 is configured with a bend, the entire length of the bone plate may be bent (e.g., to define a radius of curvature) or only one region of the bone plate may be bent out of plane relative to a remainder of the bone plate. Therefore, when discussing that bone plate 10 may have a bend 40 in the intermediate region 28 between proximal and distal regions 20, 24, it should be appreciated that the bend may or may not be isolated to that region. Rather, bend 40 may define an apex in intermediate region 28 between first fixation hole 30 and second fixation hole 34, e.g., such that the peak of the bone plate and/or maximum offset relative to the first and second fixation holes (and/or first and second terminal ends) is within this region. Depending on the application, the apex of bend 40 may be positioned along the length of bone plate 10 such that, when the bone plate is positioned across a joint separating to bone portions, the apex is substantially centered over the joint (e.g., within plus or minus 3 mm of the joint, such as plus or minus 2 mm of the joint, or plus or minus 1 mm of the joint).
Bone plate 10 can be formed of any suitable biocompatible material or combinations of materials, such as stainless steel, nitinol, titanium, and/or polymeric materials (e.g., polyether ether ketone or PEEK). Bend 40 can be formed by manufacturing bone plate 10 to include the bend (e.g., by casting or machining the bone plate initiate that includes bend 40). Alternatively, bone plate 10 can be fabricated as a planar plate that is subsequently bent (e.g., plastically deformed) to create bend 40.
Bone plate 10 can have a variety of features and configurations. For example, the width of bone plate 10 may be constant across the length of the bone plate or may vary such that one or more regions of the bone plate have a width greater than one or more other regions of the bone plate. For instance, in some implementations, bone plate 10 may have a larger width in regions containing fixation holes and a narrow width in regions between adjacent fixation holes. Additionally or alternatively, the thickness of bone plate 10 may be constant across the length of the bone plate or may vary such that one or more regions of the bone plate have a thickness greater than one or more other regions of the bone plate. For example, bone plate 10 may include pads projecting down from a remainder of the bone-facing surface 18 (e.g., in the region of the fixation holes) and/or channels that are recessed relative to a remainder of the bone-facing surface to define different thicknesses across the length of the bone plate. Example bone plate features that may be used are described in U.S. Pat. No. 10,245,088, titled “Bone Plating System and Method,” the entire contents of which are incorporated herein by reference.
Bone fasteners can be used to secure bone plate 10 to underlying bone portions. As briefly discussed above, at least one of the bone fasteners used to secure the bone plate to an underlying bone portion may be structured as a locking screw that is configured to both interlock with the bone plate and achieve compression, thereby deforming bend 40 toward underlying bone surfaces.
Thread 60 and 62 may each be a helical structure used to convert rotational motion into linear movement or force. Thread 60 and 62 may be defined by a ridge of material wrapped around an inner cylinder or cone of material in the form of a helix, to define a straight thread or a tapered thread, respectively.
Locking screw 50 can be characterized by both its lead and its pitch. Lead is the distance along the axis of the screw that is covered by one complete rotation of the screw (360°). Pitch is the distance from the crest of one thread to the next. In some examples, locking screw 50 is configured as a single lead screw, e.g., such that there is only one threaded ridge wrapped around the body of the screw. When so configured, each time the body of the screw is rotated one turn (360°), it has advanced axially by a distance equal to the pitch or spacing between adjacent ridges along the axis of the screw. In other examples, locking screw 50 is configured as a multi-lead screw, such as a dual lead screw, a tri-lead screw, or a quad-lead screw, such that each time the body of the screw is rotated one turn, it is advanced axially by a multiple of the pitch or spacing between adjacent ridges. In other words, the pitch and lead may be equal for a single lead screw but the lead may be the pitch or spacing between adjacent ridges multiplied by the number of screw starts for a multi-lead screw (e.g., pitch×2 for a dual-lead screw, pitch×3 for a tri-lead screw).
In accordance with some implementations of the present disclosure, locking screw 50 is configured to be inserted through a fixation hole of bone plate 10 and driven into an underlying bone portion. The locking screw can be configured with a compression ratio greater than 1.0. As used herein, the term “compression ratio” means the pitch of the shaft thread multiplied by the number of number of starts on the shaft thread with that sum being divided by the pitch of head thread multiplied by the starts on the head thread. This can be represented by the following equation:
In practice, the head thread 60 may typically be a single start threading. In such configurations, the compression ratio may be the pitch of shaft thread 62 divided by the pitch of head thread 60 when shaft thread 62 defines a single start screw. When shaft thread 62 defines a dual-start screw, the compression ratio may be twice the pitch of shaft thread 62 divided by the pitch of head thread 60.
The differential pitch and/or starts between head thread 60 and shaft thread 62 may be selected to be effective to deliver a compressive force to bone plate 10 when locking screw 50 is inserted into the bone plate. For example, when bone plate 10 is secured to one bone portion with a bone fastener, locking screw 50 may be inserted through a fixation hole across a joint into another bone portion. As head thread 60 of locking screw 50 engages with counter threading encircling the fixation hole of the bone plate into which the screw is inserted, shaft thread 62 may continue drawing the screw down into the underlying bone. As a result, bend 40 in bone plate 10 may deform by bowing toward the bone portions. As locking screw 50 continues to be screwed into the fixation hole a bone plate 10, bend 40 may further deform. Locking screw 50 may be inserted into the underlying bone until head 56 is fully seated within a receiving opening defined by the fixation hole the bone plate.
The specific compression ratio that is effective to achieve compression of bone plate 10 during use may vary, e.g., based on the thickness of the plate. In general, compression ratio may be greater than 1.0. As a result, one rotation (360°) of locking screw 50 may cause the shaft of the screw to traverse a larger axial distance than the axial distance the head of the screw travels seating into the counter thread defined by the fixation hole. As a result, bone plate 10 may deform a distance toward the underlying bone into which locking screw 50 is inserted to accommodate the differential travel length of the shaft relative to the head due to the compression ratio.
Bone plate 10 can include at least one fixation hole extending through body 12 in the distal region 20 of the bone plate and at least one fixation hole extending through the body and the proximal region 24 of the bone plate. In use, at least two fixation elements can be used to secure the bone plate to two different bone portions, e.g., with intermediate region 28 of the bone plate bridging the joint or gap between the two bone portions. For example, as discussed with respect to
A bone plating system that includes bone plate 10 may include at least one locking screw 50 (e.g. such as two, three, or four locking screws 50) exhibiting a compression ratio effective to deform the bend 40 in the bone plate during use. The bone plating system may include one or more other mechanical fixation elements having a different configuration than locking screw 50 that is insertable through the other fixation holes of the bone plate to complete attachment to the underlying bone portions. Any suitable fixation elements can be used for these other attachment elements, such as screws having a different configuration than locking screw 50, pins, rivets, spikes, or the like.
For example, the bone plating system may include at least one locking screw 50 exhibiting a compression ratio effective to deform the bend in bone plate 10 during use and at least one other screw (e.g., such as two, three, four or more) screws that are nonlocking screws and/or locking screws exhibiting a compression ratio less than that of locking screw 50. For example, the bone plating system may include one or more locking screws having a compression ratio less than 1.5, such as less than 1.45, less than 1.25, or less than 1.2. For example, the bone plating system may include one or more locking screws having a compression ratio that is at least 0.05 less than the compression ratio exhibited by locking screw 50 configured as described with respect to
In one implementation, a bone plating system includes a bone plate 10, at least two locking screws 50 exhibiting a compression ratio effective to deform bend 40 in the bone plate, and at least two additional locking screws having a compression ratio less than that of locking screw 50 (e.g., a compression ratio that does not result in substantial bending or any bending of the bone plate). In these systems, at least one locking screw 50 may be installed through a fixation hole on the distal region 20 of bone plate 10 and at least one locking screw 50 may be installed through fixation hole on the proximal region 24 of the bone plate. In these examples, the at least one two other locking screws having lower compression ratios than locking screw 50 may be installed through the remaining fixation holes on the distal region 20 and/or proximal region 24 of the bone plate.
It should be appreciated that reference to first, second, third, etc. for different features or elements in the disclosure is for purposes of convenience and is not intended to impose an order of operation unless otherwise specified. For example, while bone plate 10 is described as including a first fixation hole 30 positionable over first bone portion 70 and a second fixation hole 34 positionable over second bone portion 72, it should be appreciated that the first bone portion may be a metatarsal or a cuneiform in different examples. Further, during installation, the initial screw may be placed through second fixation hole 34 instead of first fixation hole 30. Accordingly, other orders of installation and arrangement of components can be used and should not be limited to the specific examples described.
In the example of
For example, when configured as illustrated in
One or more other fixation holes of bone plate 10, such as one or more fixation holes positioned proximally and/or distally of those fixation holes closest to intermediate region 28 may be secured to the underlying bone portions using screws having a different configuration than locking screw 50A, 50B. For example, one locking screw 76A may be installed through third fixation hole 32 and/or one locking screw 76B may be installed through fourth fixation hole 36. Locking screws 76A, 76B may exhibit a lower compression ratio than each of locking screws 50A and 50B (e.g., when at least two locking screws 50 are utilized).
A bone plating system that includes a nonplanar bone plate, such as bone plate 10 with bend 40, and one or more locking screws 50 that can interlock with the bone plate and generate a compressive force sufficient to deform the non-planarity of the bone plate during installation, can be useful to help compress the bone portions fixated together using the bone plate. When bone plate 10 is initially positioned over a joint separating two bone portions with the distal region 20 at least partially contacting first bone portion 70 and the proximal region 24 at least partially contacting the second bone portion 72, a gap may exist between the bone facing-surface of the bone plate and the underlying bone portions. As the one or more locking screws 50 are installed through one or more corresponding fixation holes of the bone plate 10 into underlying bone, bend 40 may deform (e.g., plastically and/or elastically) toward the underlying bone portions. This can create a residual spring force compressing the ends of the bone portions together. For example, physically compressing bend 40 from an initial apex height to a reduced apex height may place to the top side of the bone plate in compression and the underside of the bone plate in tension, creating a moment force of asymmetrically distributed magnitude across the end faces of the bones being compressed. In implementations where the bone plate system is applied on a dorsal side of two bone portions (e.g., across a metatarsophalangeal joint or across a tarsometatarsal joint), this may have a tendency to plantarflex the distal bone portion relative to the proximal bone portion, thereby compressing the bone ends across the joint to promote healing (e.g., fusion) and reinforcing a joint realignment performed prior to fixation.
During installation, bone plate 10 can be positioned across joint 74, e.g., with the apex of bend 40 substantially centered over the joint. First fixation hole 30 may be positioned over an underlying first bone portion 70, and second fixation hole 34 may be positioned over an underlying second bone portion 72. For example, distal region 20 may at least partially contact first bone portion 70 and proximal region 24 may at least partially contact second bone portion 72 with bend 40 elevated above the surface of one or both bone portions. As a result, a gap 80 may exist between bone-facing surface 18 of bone plate 10 and the joint line defined by the ends of the bones underneath bend 40. The size of gap 80 may vary, e.g., depending on the extent of bend 40, and in some examples is at least 1 mm, such as at least 1.5 mm, at least 1.75 mm, at least 2 mm, at least 2.25 mm, at least 2.5 mm, at least 3 mm, at least 3.5 mm, at least 4 mm, or at least 5 mm.
The clinician may attach bone plate 10 to the first and second bone portions 70, 72 by inserting one or more locking screws 50A, 50B through one or more corresponding fixation holes of the bone plate. For example, the clinician may insert a first locking screw 50A through first fixation hole 30 and screw the locking screw into the underlying first bone portion 70. The clinician may continue advancing first locking screw 50A until the head thread on the locking screw is partially but not fully engaged with the counter threading extending around first fixation hole 30 (e.g., such that the head threading on the locking screw is partially engaged with the counter threading but can continue to be advanced downwardly relative to the counter threading). If the opposite side of bone plate 10 is already secured to second bone portion 72 using a fixation element, the clinician may further screw first locking screw 50A into first bone portion 70. As the shaft thread of first locking screw 50A advances down into first bone portion 70 after the head thread of the locking screw is initially engaged with the counter thread on the fixation hole, the compression ratio provided by the differential configuration of the head and shaft thread may generate a compressive force that causes bend 40 to deform towards joint 74.
Depending on the order of operation, before or after installing first locking screw 50A into first bone portion 70, the clinician may insert a second locking screw 50B through second fixation hole 34 and screw the locking screw into the underlying second bone portion 72. The clinician may continue advancing second locking screw 50B until the head thread on the locking screw is partially or fully engaged with the counter threading extending around second fixation hole 34 (e.g., such that the head threading on the locking screw is partially engaged with the counter threading but can continue to be advanced against the counter threading or is fully seated with the locking threading). The clinician may further screw second locking screw 50B into second bone portion 72. As the shaft thread of second locking screw 50B advances down into second bone portion 72 after the head thread of the locking screw is initially engaged with the counter thread on the fixation hole, the compression ratio provided by the differential configuration between the head and shaft thread may generate a compressive force that causes bend 40 to deform (e.g., further deform) towards joint 74.
As bend 40 of bone plate 10 deforms towards the facing surfaces of the underlying bone portions and/or joint 74, the bend may flatten. For example, when the bend 40 is characterized by a radius of curvature, the radius of curvature may be smaller when the bend is undeformed (
As shown in
In some examples, a difference in angle 90 prior to deformation minus angle 90 prior after deformation is 90 degrees or less, such as 60 degrees or less, 45 degrees or less, 30 degrees or less, or 20 degrees or less. For example, angle 90 prior to deformation may range from 15 degrees to 90 degrees, such as from 20 degrees to 45 degrees. After deformation, angle 90 may range from 0 degrees to 45 degrees, such as from 5 degrees to 15 degrees. In one specific example, angle 90 may be within a range from 20 to 30 degrees prior to deformation and may be in a range from 5 to 15 degrees after deformation.
As the bend or arch in bone plate 10 is physically deformed toward a flattened or unbent profile (e.g., resulting in a complete flattening of the plate or a residual bend or arch of smaller height after deformation), an underside of the plate may be placed in tension and a topside of the plate placed in compression. As a result, a moment force may be applied that has an asymmetrically distributed magnitude across the end faces of the bones being compressed. FIG. 6B illustrates an example triangular distributed load profile that may be created across the end faces of the bone portions by deformation of the bone plate. An asymmetrically distributed force pressing the end faces of the bone portions together may be greater on a side (e.g., a cortex) of the bone portions opposite the side in contact with bone plate 10 than a side (e.g., a cortex) of the bone portions no the side in contact with the bone plate.
Features described as screws, including locking screw 50, can be formed of any suitable biocompatible material or combinations of materials, such as stainless steel, nitinol, titanium, and/or polymeric materials (e.g., polyether ether ketone or PEEK). The screws may be single axial screws and/or polyaxial screws. Further, the screws may be cannulated or non-cannulated and/or may be self-tapping or non-self-tapping. In some examples, one or more of the screws are cannulated (e.g., all of the screws). In other examples, one or more of the screws are non-cannulated (e.g., all of the screws).
The screws, including locking screw 50, and bone plate 10 may be sized based on the desired application for the plating system. In some examples, each screw used with bone plate 10 is sized to be inserted into a metatarsal and/or cuneiform of a human foot. For example, each screw may have a length ranging from 8 mm to 18 mm, such as from 10 mm to 16 mm, or from 12 mm to 14 mm. When provided with screws intended to be inserted into both the metatarsal and cuneiform, the screws may be the same size, or one may be longer than the other (e.g., by 1 mm, 2 mm, or more). Although the diameter of the shaft of the screws may vary, in some examples, the diameter ranges from 2 mm to 4 mm, such as from 2.5 mm to 3.2 mm.
To correct an alignment of a first bone portion (e.g., metatarsal) relative to a second bone portion (e.g., cuneiform), for example, the clinician may surgically access the joint between the two bone portions. Once accessed the clinician may prepare end faces of the two bone portions. The clinician can prepare the end of each bone so as to promote fusion of the bone ends across the joint following realignment. Bone preparation may involve using a tissue removing instrument to apply a force to the end face of the bone so as to create a bleeding bone face to promote subsequent fusion. Example tissue removing instruments that can be used include, but are not limited to, a saw, a rotary bur, a rongeur, a reamer, an osteotome, a curette, and the like. The tissue removing instrument can be applied to the end face of the bone being prepared to remove cartilage and/or bone. For example, the tissue removing instrument may be applied to the end face to remove cartilage (e.g., all cartilage) down to subchondral bone. Additionally or alternatively, the tissue removing instrument may be applied to cut, fenestrate, morselize, and/or otherwise reshape the end face of the bone and/or form a bleeding bone face to promote fusion. In instances where a cutting operation is performed to remove an end portion of a bone, the cutting may be performed freehand or with the aid of a cutting guide having a guide surface positionable over the portion of bone to be cut. When using a cut guide, a cutting instrument can be inserted against the guide surface (e.g., between a slot define between two guide surfaces) to guide the cutting instrument for bone removal.
Either before or after preparing one or both ends of the bone portions, the clinician may move one bone portion (e.g., the metatarsal) in at least one plane, such as at least the transverse plane to close an intermetatarsal angle between the bone portion (e.g., a first metatarsal) and an adjacent bone (e.g., a second metatarsal) and/or a frontal plane to reposition the sesamoid bones. In some examples, the clinician moves the bone portion in multiple planes, such as the transverse plane and/or frontal plane and/or sagittal plane. The clinician may or may not utilize a bone positioning guide to facilitate movement of the bone portion. With the bone portion moved to a desired position, the clinician can optionally provisionally fixate the moved position (e.g., by inserting a k-wire through the moved bone portion into an adjacent bone portion) and then permanently fixate the moved position using one or more bone plate systems as described herein. Details on example bone realignment instruments and techniques that can be used in conjunction with the present disclosure are described in U.S. Pat. No. 9,622,805, issued Apr. 18, 2017 and entitled “BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS,” the entire contents of which are incorporated herein by reference.
In some applications, independent of whether the clinician performs the specific bone realignment technique discussed above, the clinician temporarily or provisionally fixates first bone portion 70 relative to second bone portion 72 prior to attaching bone plate 10 across the joint separating the two bone portions. The clinician may press the end faces of first bone portion 70 and second bone portion 72 together, e.g., with hand pressure and/or using compressing instrument physically attached to both the first bone portion and the second bone portion. For instance, the clinician may attach compressing instrument to the first bone portion 70 with one or more fixation pins and also attach the compressing instrument to the second bone portion using one or more fixation pins. The compressing instrument may have a mechanism (e.g., threaded rod, rack and pinion) that presses against the pins inserted through the two bone portions to compress the end faces of the two bone portions together. Additional details on example compressing instruments that may be used can be found in US Patent Publication No. 2020/0015856, published Jan. 16, 2020 and entitled “COMPRESSOR-DISTRACTOR FOR ANGULARLY REALIGNING BONE PORTIONS,” the entire contents of which are incorporated herein by reference.
In some implementations, the clinician inserts one or more fixation pins through the end faces of the first bone portion 70 and second bone portion 72 in addition to or in lieu of compressing the end faces with a compressing instrument. The fixation pin may be a k-wire, olive wire (e.g., pin with region of enlarged cross-section) or other fixation pin structure. The fixation pin crossing joint 74 between first bone portion 70 and second bone portion 72 can help provisionally fixate and/or compress the end faces of the two bone portions together prior to installation of bone plate 10 for permeant fixation (and subsequent fusion of the bone faces together). When used, the one or more fixation pins can be removed from the end faces of the two bone portions and across the joint between the bone portions after installation of bone plate 10 (e.g., after installation of at least one fixation element through the bone plate into each of first bone portion 70 and second bone portion 72).
With further reference to
The technique of
With the distal end of locking screw 50 inserted through the first fixation hole of bone plate 10, the clinician can screw the locking screw into the underlying bones (106). Operating under hand power or with the aid of a rotary drill instrument, the clinician can rotate locking screw 50 in either a clockwise or counterclockwise direction (depending on the pattern of the thread) so as to advance the screw axially downwardly into the bone portion underlying the fixation hole in the bone plate. The clinician can continue screwing locking screw 50 and advancing the screw axially into the bone portion. When the head thread on the head of locking screw contacts the counter threading encircling the first fixation hole, the head thread may interleave with the counter threading encircling the first fixation hole thereby engaging the threading.
With the head thread at least partially engaged with the counter thread defined by the first fixation hole, the technique of
Prior to and/or after installing locking screw 50 through the first fixation hole of the bone plate, the clinician can install one or more fixation elements, such as one or more locking screws through one or more additional fixation holes of the bone plate. For example, prior to or after installing locking screw 50 through the first fixation hole into the first bone portion, the clinician may install another locking screw (which may or may not have a comparatively high compression ratio) through the second fixation hole into the second bone portion. The clinician may install one or more additional screws, such as one or more additional locking screws (which may or may not have a comparatively high compression ratio) through other fixation holes in the bone plate, such as a third fixation hole and a fourth fixation hole.
A bone plating system applied across a joint separating the ends of two bone portions as described herein can help compress the end faces of the two bone portions together to facilitate fusion. In some examples, the plating system produces asymmetric compression in which the far cortex of the bone ends is compressed more than the near cortex. In some applications, such as when the bone plate is applied to the dorsal surface of the bone portions, this can help plantarflex the realigned bone portion and reinforce a corrective realignment in the sagittal plane while facilitating fusion. Additionally or alternatively, when the bone plate is applied to the medial surface of the bone portions, this can help laterally bias the realigned bone portion and reinforce a corrective realignment in the transverse plane (e.g., bias toward closing the intermetatarsal angel) while facilitating fusion.
A variety of different instruments and additional or alternative techniques can be used to facilitate installation of a bone plating system as described herein. For example, one or more driving pins (e.g., plate tack pins, drill pins) may be used to help facilitate installation of bone plate 10. When used, the driving pin may be inserted through a fixation hole of the bone plate and into the underlying bone. In some examples, the driving pin includes a threaded distal region and can be rotationally driven into the underlying bone via screwing. In either case, the driving pin may enter or bore a hole in the bone portion underlying the fixation hole through which the driving pin is inserted.
In some implementations, the driving pin may include an enlarged region having a larger cross-sectional area than a cross-sectional area of the fixation hole. As the driving pin is advanced into the underlying bone, the region of larger cross-sectional area may press against a top side of bone plate 10 (e.g., either directly against the top side or indirectly via a drill guide extending above the top surface). Continued rotation of the driving pin may cause the enlarged cross-sectional area to deform bend 40 by compressing the bend portion toward the underlying joint and/or surfaces of the bone portions. As a result, the bone plate may be partially or fully deformed toward a desired degree of compression by the driving pin. The driving pin can then be removed from the fixation hole and a locking screw inserted through the fixation hole and into the underlying bone. Another fixation device, such as a pin, screw, etc. may be placed through one or more adjacent holes prior to removing the driving pin to help hold the compression of the bone plate for installation of the locking screw.
When bone plate 10 is pre-deformed using a driving pin prior to installation of one or more screws, the screws used to affix the bone plate to the underlying bone portions may or may not include locking screw 50 exhibiting a comparatively high compression ratio. In some applications using a driving pin for pre-deformation, at least one (and optionally all) fixation elements used to secure the deformed bone plate to the underlying bone may be non-locking screws or locking screws configured with a lower compression ratio (e.g., one not effective to substantially deform the plate upon installation, such as compression ratio less than 1.5, or a compression ratio of 1.0). That said, in some implementations, locking screw 50 with an enhanced compression ratio may be installed (e.g., through one or both fixation holes closest to joint 74) to help affix the bone plate to the underlying bone portions.
In the illustrated example, driving pin 120 defines a body that extends from a proximal end 122 to a distal end 124. The body defines multiple regions of different cross-sectional thickness which, in the illustrated example, is shown as at least three regions of different cross-sectional thickness. For example, the body of driving pin 120 may define a bone penetrating region 126 adjacent the distal end, a driving region 128 adjacent the proximal end, and bone plate orienting region 130 between the bone penetrating region and the driving region. Bone penetrating region 126 can have a smaller cross-sectional thickness than the bone plate orienting region 130. Bone plate orienting region 130 may have a smaller cross-sectional thickness than driving region 128 or, in other implementations, can have the same cross-sectional thickness or a larger cross-sectional thickness than driving region 128.
Configuring driving pin 120 with multiple cross-sectional thicknesses can be useful to provide different functionalities while limiting unnecessary trauma to the bone in which the driving pin is engaged. For example, bone penetrating region 126 can be sized comparatively small to minimize bone damage and ease insertion of the distal end of the driving pin. Bone plate orienting region 130 may be larger and be sized complementary to the dimeter of a fixation hole of the bone plate in which the driving pin is to be inserted. This can provide close conformance between the driving pin and the bone plate, e.g., for accurately rotating the bone plate about the driving pin to orient the bone plate during installation. Driving region 128 may be larger and sized for engagement with a driver to be used in the process. In some configurations, driving pin 120 is provided as part of a kit that includes other driving instruments (e.g., pins, k-wires) and has the same diameter as one or more of those other instruments to provide a uniform driving connection size across the instruments. In other words, driving pin 120 may be part of a kit (e.g., where all the components of the kit art contained in a sterile case) having one or more (and optionally two or more) other instruments, each having a substantially same diameter shaft and each being configured to couple to a same driver for driving the instruments.
As shown in
Although driving pin 120 is illustrated as including a threaded bone penetrating region 126 and an unthreaded plate orienting region 130, the driving pin need not have the two distinct regions. Rather, when bone penetrating region 126 and plate orienting region 130 are configured with the same cross-sectional size, the threading may optionally extend to also encompass the region of the driving pin that functions as the plate orienting region.
In general, driving pin 120 can have any have desired cross-sectional shape, including polygonal shapes, arcuate shapes, and combinations thereof. In some configurations, at least bone penetrating region 126, driving region 128, and bone plate orienting region 130 of the driving pin have a circular cross-sectional shape.
While driving pin 120 have a variety of different sizes, in some examples, bone penetrating region 16 has a diameter ranging from 0.1 mm to 2 mm and/or bone plate orienting region 130 has a diameter ranging from 0.5 to 3 mm and/or driving region 128 has a diameter ranging from 1.6 mm to 3.7 mm. For example, bone penetrating region 126 may have a diameter ranging from 1 mm to 2 mm, and bone plate orienting region 130 may have a diameter ranging from 1 mm to 2 mm.
Driving pin 120 can have one or more regions of different cross-sectional thickness than bone penetrating region 126, driving region 128, and bone plate orienting region 130. For example, in the illustrated example, driving pin 120 includes a fourth region 132 of greater cross-sectional thickness than at least bone penetrating region 126 and bone plate orienting region 130. In the illustrated configuration, fourth region 132 also has a cross-sectional thickness greater than driving region 128. Fourth region 132 is positioned proximally of bone plate orienting region 130 and can have a cross-sectional thickness greater than that of a bone plate fixation hole diameter and/or drill guide into which driving pin 120 is configured to be inserted. Fourth region 132 can function as a feature that limits that downward insertion depth of driving pin 120 as it is being inserted through a bone plate and/or drill guide. When included, fourth region 132 may be integral (e.g. permanently formed with) a remainder of the driving pin body or may be part of a multi-piece assembly that is separately attachable to the driving pin.
Fourth region 132 can have any desired cross-sectional shape (e.g., round, spherical, rectangular, triangular, elliptical), and the cross-sectional shape may be the same as or different than that of adjacent sections of the driving pin. In some examples, fourth region 132 has a cross-sectional thickness ranging from 1.5 mm to 12 mm, such as from 2 mm to 5 mm. Additional details on example driving pin techniques and devices that may be used are described in US Patent Publication No. 2020/0015870, filed Jul. 12, 2019 and titled “MULTI-DIAMETER BONE PIN FOR INSTALLING AND ALIGNING BONE FIXATION PLATE WHILE MINIMIZING BONE DAMAGE, the entire contents of which are incorporated herein by reference.
As shown in
Continuing with
As shown in
To retain bone plate 10 for insertion of a screw, a third fixation pin 150 can be inserted into an adjacent fixation hole of the bone plate to the fixation hole in which the screw is desirably inserted, as shown in
In either case, first driving pin 120A can be removed from first fixation hole 30 to open the fixation hole for installation of a locking screw, as illustrated in
With locking screw 50 installed through first fixation hole 30 to secure bone plate 10 to cuneiform 70, third fixation pin 150 (when used) can be removed from the cuneiform. In addition, second driving pin 120B can be removed from metatarsal 72 and a screw screwed through second fixation hole 34 to secure the bone plate to the metatarsal. The screw inserted through second fixation hole 34 can be locking screw 50 or a different type of screw structure or other fixation element as described herein. In some examples, a fixation pin (e.g., third fixation pin 150) is inserted through fourth fixation hole 36 before removing second driving pin 120B.
In some applications, however, the clinician may desire to install multiple bone plates across the joint rather than only installing a single bone plate. The multiple bone plates may be positioned at different locations about the perimeter of the joint so as to provide a biplanar plating construct. In these applications, each bone plate and/or screws may be configured and installed according to the present disclosure, or one bone plate system may be different than the other bone plate system. In some such applications, the clinician may proceed to begin installing the second bone plate before completing installation of the first bone plate. For example, the clinician may proceed to begin installing the second bone plate after securing the first bone plate through the first and second fixation holes 30, 34 but prior to installing screws through other fixation holes (e.g., the third and/or fourth fixation holes 32, 36).
For example,
Continuing with
As shown in
To retain bone plate 10 for insertion of a screw, a third fixation pin 150 can be inserted into an adjacent fixation hole of the bone plate to the fixation hole in which the screw is desirably inserted, as shown in
In either case, first driving pin 120A can be removed from first fixation hole 30 to open the fixation hole for installation of a locking screw, as illustrated in
With locking screw 50 installed through first fixation hole 30 to secure bone plate 10 to cuneiform 70, third fixation pin 150 (when used) can be removed from the cuneiform. In addition, second driving pin 120B can be removed from metatarsal 72 and a screw screwed through second fixation hole 34 to secure the bone plate to the metatarsal. The screw inserted through second fixation hole 34 can be locking screw 50 or a different type of screw structure or other fixation element as described herein. In some examples, a fixation pin (e.g., third fixation pin 150) is inserted through fourth fixation hole 36 before removing second driving pin 120B.
Securing a first bone plate 10 with a single screw connecting the bone plate to an underlying bone portion (e.g., metatarsal 72) and then attaching the second bone plate 10B prior to completing attachment of the first bone plate 10 may be useful for a variety of reasons. With only a single screw securing the first bone plate 10 to the bone portion, the bone portion may be further manipulable during installation of the second bone plate 10B. For example, the clinician may be able to pivot metatarsal 72 around the single screw connecting the first bone plate 10 to the metatarsal. This can provide some degree of mobility or freedom for the clinician to adjust the position of the first metatarsal in the transverse plane, frontal plane, and/or sagittal plane prior to or concurrent with attaching the second bone plate 10B. Additionally or alternatively, this arrangement provides mobility to allow the bend 40 in the second bone plate 10B (when so configured) to be deformed to provide additional reinforcing correction of the bone portion (e.g., biasing the metatarsal laterally to close the intermetatarsal angle).
Once second bone plate 10B is attached to medial cuneiform 70 and first metatarsal 72 with screws inserted through first and second fixation holes 30, 34 of the bone plate, the clinician can proceed to complete attachment of the first bone plate 10 and/or second bone plate 10B. For example, the clinician may install screws through third fixation hole 32 and fourth fixation hole 36 of the first bone plate 10 and/or second bone plate 10B into the underlying bones to complete installation as shown in
It should be appreciated that the foregoing discussion of example procedural steps described in connection with
In instances where a bone plating system according to the disclosure is applied to both a dorsal side and a medial side of a metatarsal and cuneiform, the two bone plates may reinforce a realignment introduced during a bone realignment procedure. For example, bone plate attached the dorsal side of the metatarsal and cuneiform may apply an asymmetrically distributed force that is greater on the plantar side of the joint than the dorsal side of the joint, which may have a tendency to plantarflex the metatarsal. The bone plate attached the medial side of the metatarsal and cuneiform may apply an asymmetrically distributed force that is greater on the lateral side of the joint than the medial side of the joint, which may have a tendency to bias the distal end of the metatarsal laterally to close an intermetatarsal angle between the metatarsal to which the bone plate is attached and an adjacent metatarsal.
As described above, bone plate 10 may be positioned over two bone portions to be fixated together with the plate. The bone plate may be positioned over the bone portions in an undeformed state, e.g., prior to compressing bend 40. Once positioned over one or both bone portions, the bone plate can be deformed, for example, by inserting one or more locking screws and/or driving pins or equivalent compressive threaded elements through the fixation hole(s) of the bone plate. This can cause the bend in the bone plate to deform toward a more flattened profile.
In yet additional examples, bone plate 10 with bend 40 may be pre-tensioned (e.g., pre-compressed) before or concurrent with being positioned over a joint between two adjacent bone portions to be fixated. For example, using hand manipulation and/or a bending instrument, bend 40 of the plate may be compressed toward a more planar shape and held in compression while placed spanning the join between the bone portions being fixated. While held in compression, one or more driving pins and/or fixation elements (e.g., screws) can be inserted through the fixation holes of the bone plate into the underlying bone portions.
In these examples, bone plate 10 may have a configuration and may be deformed according to any of the shape profiles and configurations discussed above, albeit with the deformation occurring at least partially prior to attachment of the bone plate to one or both underlying bone portions. In these applications, at least one (and optionally all) fixation elements used to secure the pre-deformed bone plate to the underlying bone portion(s) may be non-locking screws or locking screws configured with a lower compression ratio (e.g., one not effective to substantially deform the plate upon installation, such as compression ratio less than 1.5, or a compression ratio of 1.0). That said, in some implementations, locking screw 50 with an enhanced compression ratio may be installed (e.g., through one or both fixation holes closest to joint 74) to help affix the pre-deformed bone plate to the underlying bone portions.
Once pre-compressed, the comparatively flat plate can be positioned over the two bone portions to be fixated together and held to one or both bone portions with a driving pin or other fixation feature. Plate bending arms 160 can then be removed, the screw holes prepared, and screws plated through the fixation holes of the plate and into underlying bone.
When bone plate 10 is pre-compressed prior to installation, the screws used to fixate the plate to the underlying bone portions may or may not include a locking screw 50 as described above with comparatively high compression ratio. In some implementations, all the screws utilized to fixate the bone plate to the underlying bone portions may be non-locking screws or locking screw with lower compression ratio.
In some implementations, the components of the bone plate systems described herein (e.g., one or more bone plates, screws and/or other fixation elements) may be provided as part of a kit. The kit may be a disposable single-use surgical kit. The terms “disposable” and “single-use” are meant to convey that the surgical kit, in addition to all components included in the surgical kit, is intended for use on only one surgical patient. After the surgical procedure on the one surgical patient is completed, any components that are not implanted into the one surgical patient can be discarded using conventional methods.
The kit can include a sterile container in which various surgical items can be contained. The container can be sterilized using any appropriate sterilizing means (e.g., exposure to ethylene oxide, steam autoclave, gamma radiation). In one example, the various surgical items can be placed into the container, and the container and the various surgical items included in the container can be sterilized in a single step. The sterile container may be partially or wholly enclosed in a packaging that can serve to protect the container as well as seal and maintain a sterility of the container. The packaging and/or the sterile container can be made of a transparent material, such as an appropriate polymer, to allow viewing of the surgical items included in the container.
The disposable single-use kit can include all or any combination of one or more of the described surgical items. The items to be included in the kit may vary depending on the specific surgical procedure for which the kit is intended to be used. Other embodiments of the kit can include two or more sterile packages with different components in each sterile package. For example, a first sterile package containing the bone plates, fasteners, and pins may be provided along with a second sterile package containing instruments such as plate manipulation and/or bone preparation instruments. Such a kit can also be provided in modular form with components grouped together in separate sterile packages to be selected to provide a complete kit for the desired surgical procedure.
Various examples have been described. These and other examples are within the scope of the following claims.
This application claims the benefit of U.S. Provisional Patent Application No. 63/138,726, filed Jan. 18, 2021, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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63138726 | Jan 2021 | US |