Osteotomy procedure for correcting bone misalignment

Information

  • Patent Grant
  • 11931047
  • Patent Number
    11,931,047
  • Date Filed
    Monday, August 2, 2021
    2 years ago
  • Date Issued
    Tuesday, March 19, 2024
    a month ago
Abstract
An osteotomy procedure may be performed to correct a misalignment of a bone, such as a bunion deformity. In some examples, the osteotomy procedure involves making a spherical-shaped cut transecting a first metatarsal, thereby forming a first metatarsal portion having a spherical-shaped projection and a second metatarsal portion having a spherical-shaped recess. The method further involves moving the second metatarsal portion in at least two planes relative to the first metatarsal portion, thereby adjusting an anatomical alignment of the second metatarsal portion.
Description
TECHNICAL FIELD

This disclosure relates to devices and techniques for correcting bones and, more particularly, to osteotomy techniques for correcting bone misalignment.


BACKGROUND

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.


SUMMARY

In general, this disclosure is directed to devices and techniques for correcting an anatomical misalignment of one or more bones. In some examples, the technique involves making a generally crescent-shaped cut transecting a bone to form a concave-shaped end and a convex-shaped end. The two resulting bone portions can be distracted, or separated from each other, and a second cut performed on the concave-shaped end of the resulting bone portion. The second cut may also be a generally crescent-shaped cut but may be angled with respect to the concavity resulting from the first cut. For example, the first generally crescent-shaped cut may form a saddle and the second generally crescent-shaped cut may form an intersecting and offset saddle on a bone portion. The corresponding convex bone portion may be moved in multiple planes to adjust the alignment of the bone portion. For example the convex bone portion may be moved from the first saddle to the adjacent second saddle thereby facilitating realignment of the bone portion.


As one example, the technique may be performed on a first metatarsal to correct a bone alignment deformity, such as a bunion deformity. A first generally crescent-shaped cut can be made parallel to or at an offset angle relative to a frontal plane of the metatarsal transecting the metatarsal into two portions: one portion having a convex-shaped end and an opposed portion having a concave-shaped end. A second crescent shape cut may be made at an angle relative to a transverse plane bisecting the portion of the metatarsal having a convex-shaped end. This second cut may chamfer or remove a portion of the convex-shaped bone end, such as a dorsal lateral quadrant of the bone end. This can facilitate subsequent realignment of the concave-shaped end of the opposing bone portion relative to the convex-shaped end.


In another alternative, a bone realignment technique may be performed by making a single generally crescent-shaped cut instead of two generally crescent-shaped cuts. In this technique, a generally crescent-shaped cut can be made parallel to or at an offset angle relative to a frontal plane of the metatarsal transecting the metatarsal into a portion having a convex-shaped end and an opposed portion having a concave-shaped end. A planar, transverse cut can then be made across the bone portion having the convex-shaped end resulting in three bone portions: a bone portion having a concave-shaped end, a bone portion having a planar end, and an intermediate bone portion having one planar end and one convex-shaped end. The intermediate bone portion can be translated along the arc of the curve formed by the concave-shaped end to reorient the metatarsal in the transverse plane. The bone portion having the planar end can also be rotated relative to the intermediate portion in the frontal plane. After suitably reorienting the three bone portions relative to each other, three bone portions can be fixated together.


In other applications, a bone realignment technique may be performed without requiring multiple cuts. In these applications, a generally spherical-shaped cutting member can be used to transect the bone being realigned. For example, a generally spherical-shaped cutting device can be used to transect a first metatarsal resulting in a one bone portion having a generally spherical-shaped projection and an opposed bone portion having a generally spherical-shaped socket. The two bone portions can then be reoriented in multiple planes relative to each other with or without performing additional cuts on a bone portion. In either case, after suitably realigning one bone portion relative to another bone portion, the bone portions may be permanently fixated to each other. For example, using plates, screws, pins and/or other fixation hardware, one bone portion may be fixed to the opposed bone portion.


In yet further applications, a bone realignment technique may be performed by transecting a bone with a substantially linear (e.g., non-curved) cutting member by making a transverse cut across the bone. For example, a planar saw blade can be used to transect a first metatarsal resulting in a first bone portion and separate second bone portion that each have planar cut end faces. The two bone portions can then be reoriented in multiple planes relative to each other with or without performing additional cuts on a bone portion. After suitably realigning one bone portion relative to another bone portion, the bone portions may be permanently fixated to each other. For example, using plates, screws, pins and/or other fixation hardware, one bone portion may be fixed to the opposed bone portion.


Independent of the specific cutting technique or shape of cutting instrument used to cut the bone into two portions for realignment, a distal bone portion may be realigned relative to a proximal bone portion in multiple planes with or without the use of intra-operative fluoroscopy. In some examples, the clinician uses fluoroscopic imaging to visually assist in and/or guide realignment of the distal bone portion relative to the proximal bone portion. The relative position and/or degree of angular rotation of the distal bone portion relative to the proximal bone portion can be viewed by the clinician under fluoroscopic imaging and used to guide the degree of realignment. The clinician may view the movement of the distal bone portion relative to the proximal bone portion continuously while making the realignment or at one or more intervals to check the realignment made or being made. The clinician may use various anatomical landmarks visible via fluoroscopy, such as the rotational position of the distal metatarsal head and/or the position of the sesamoid bones to help determine when the distal bone portion is suitably realigned.


In some examples, the clinician may introduce one or more pins into the distal bone portion and/or proximal bone portion to help facilitate realignment. For example, the clinician may insert a first pin in a distal bone portion and a second pin in a proximal bone portion. The clinician can use the one or more pins as a grasping element, e.g., by grasping an inserted pin and using the pin to manipulate and control movement of the distal bone portion relative to the proximal bone portion. The clinician may or may not monitor the relative position and/or degree of angular rotation of the one or more pins during movement to help set the desired degree of realignment of the distal portion relative to the proximal portion. For example, the clinician may monitor the relative position and/or degree of angular rotation between a pin inserted into the proximal bone portion and another pin inserted in the distal bone portion during realignment to help set the desired degree of realignment of the distal portion relative to the proximal portion. The clinician can monitor the position of the pin(s) visually (e.g., with the unaided eye) and/or using fluoroscopic imaging.


In one example, a method is described that involves making a first crescentic-shaped cut transecting a first metatarsal, thereby forming a first metatarsal portion having a concave-shaped end and a second metatarsal portion having a convex-shaped end. The method further involves making a second crescentic-shaped cut across the concave-shaped end of the first metatarsal portion. In addition, the method includes moving the second metatarsal portion in at least two planes relative to the first metatarsal portion, thereby adjusting an anatomical alignment of the second metatarsal portion.


In another example, a method is described that includes making a spherical-shaped cut transecting a first metatarsal, thereby forming a first metatarsal portion having a spherical-shaped projection and a second metatarsal portion having a generally spherical-shaped recess. The method also involves moving the second metatarsal portion in at least two planes relative to the first metatarsal portion, thereby adjusting an anatomical alignment of the second metatarsal portion.


In another example, a method is described that includes making a crescentic-shaped cut transecting a first metatarsal, thereby forming a first metatarsal portion having a concave-shaped end and a second metatarsal portion having a convex-shaped end. The method also involves making a planar cut across the second metatarsal portion and offset from the concave-shaped end or the convex-shaped end, thereby forming a planar end on the second metatarsal portion and an intermediate bone portion having the convex-shaped end. In addition, the method includes moving the second metatarsal portion relative to the first metatarsal portion and the intermediate bone portion, thereby adjusting an anatomical alignment of the second metatarsal portion.


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.





BRIEF DESCRIPTION OF DRAWINGS


FIGS. 1A and 1B are front views of a foot showing a normal first metatarsal position and an example frontal plane rotational misalignment position, respectively.



FIGS. 2A and 2B are top views of a foot showing a normal first metatarsal position and an example transverse plane misalignment position, respectively.



FIGS. 3A and 3B are side views of a foot showing a normal first metatarsal position and an example sagittal plane misalignment position, respectively.



FIGS. 4A-4D are flow diagrams illustrating example osteotomy techniques for correcting an anatomical alignment.



FIGS. 5A-5D show example procedural steps that can be performed to correct an anatomical misalignment of a bone.



FIGS. 6 and 7 are perspective and frontal views, respectively, showing overlapping arcuate cuts that can be made to form first and second crescentic-shaped cuts, respectively.



FIGS. 8A and 8B show frontal views of an example proximal bone portion at different stages of an example osteotomy technique.



FIGS. 9A and 9B illustrate exemplary movement of a distal portion of a first metatarsal relative to a proximal portion.



FIGS. 9C and 9D are frontal plane views showing examples sesamoid bone positions before and after an example anatomical realignment, respectively.



FIG. 10 illustrates an example bone plate and example cutting guide that may be used to perform an osteotomy technique according to the disclosure



FIGS. 11A-11C show example procedural steps that can be performed to correct an anatomical misalignment of a bone using a combination of crescentic-shaped and planar cuts.



FIG. 12 illustrates an example fixation arrangement that includes a first bone plate and a second bone plate.



FIG. 13 is an illustration of an example generally spherical-shaped cutting blade that can be used to transect a metatarsal during a bone realignment procedure.



FIGS. 14A and 14B are illustrations of example end faces formed by transecting a first metatarsal with a generally spherical-shaped cutting blade.



FIGS. 15A-15D illustrate example osteotomy procedure steps that may be performed to realign a bone or bone portion using a planar cutting instrument according to the technique of FIG. 4D.



FIGS. 16A and 16B are example images showing how a guide pin can be used during to help facilitate realignment of one bone portion relative to another bone portion.



FIGS. 17A and 17B are additional example images showing how guide pins can be used during to help facilitate realignment of one bone portion relative to another bone portion.



FIGS. 18A and 18B are fluoroscopic images showing example anatomical landmarks that a clinician may monitor to guide realignment of a bone portion.





DETAILED DESCRIPTION

In general, the present disclosure is directed to devices and techniques for correcting a misalignment of one or more bones. The disclosed devices and techniques can be implemented in an osteotomy procedure in which a bone is surgically cut and/or a piece of bone is surgically removed. In some examples, the technique is performed on one or more bones in the foot or hand, where bones are relatively small compared to bones in other parts of the human anatomy. For example, the foregoing description generally refers to example techniques performed on the foot and, more particularly a metatarsal of the foot. However, the disclosed techniques may be performed on other bones, such as the tibia, fibula, ulna, humerus, femur, or yet other bone, and the disclosure is not limited in this respect unless otherwise specifically indicated. In some applications, however, the disclosed techniques are used to correct a misalignment between a metatarsal (e.g., a first metatarsal) and a second metatarsal and/or a cuneiform (e.g., a medial, or first, cuneiform), such as in a bunion correction surgery.



FIGS. 1-3 are different views of a foot 200 showing example anatomical misalignments that may occur and be corrected according to the present disclosure. Such misalignment may be caused by a hallux valgus (bunion), natural growth deformity, or other condition causing anatomical misalignment. FIGS. 1A and 1B are front views of foot 200 showing a normal first metatarsal position and an example frontal plane rotational misalignment position, respectively. FIGS. 2A and 2B are top views of foot 200 showing a normal first metatarsal position and an example transverse plane misalignment position, respectively. FIGS. 3A and 3B are side views of foot 200 showing a normal first metatarsal position and an example sagittal plane misalignment position, respectively. While FIGS. 1B, 2B, and 3B show each respective planar misalignment in isolation, in practice, a metatarsal may be misaligned in any two of the three planes or even all three planes. Accordingly, it should be appreciated that the depiction of a single plane misalignment in each of FIGS. 1B, 2B, and 3B is for purposes of illustration and a metatarsal may be misaligned in multiple planes that is desirably corrected.


With reference to FIGS. 1A and 2A, foot 200 is composed of multiple bones including a first metatarsal 210, a second metatarsal 212, a third metatarsal 214, a fourth metatarsal 216, and a fifth metatarsal 218. The metatarsals are connected distally to phalanges 220 and, more particularly, each to a respective proximal phalanx. The first metatarsal 210 is connected proximally to a medial cuneiform 222, while the second metatarsal 212 is connected proximally to an intermediate cuneiform 224 and the third metatarsal is connected proximally to lateral cuneiform 226. The fourth and fifth metatarsals 216, 218 are connected proximally to the cuboid bone 228. The joint 230 between a metatarsal and respective cuneiform (e.g., first metatarsal 210 and medial cuneiform 222) is referred to as the tarsometatarsal (“TMT”) joint. The joint 232 between a metatarsal and respective proximal phalanx is referred to as a metatarsophalangeal joint. The angle 234 between adjacent metatarsals (e.g., first metatarsal 210 and second metatarsal 212) is referred to as the intermetatarsal angle (“IMA”).


As noted, FIG. 1A is a frontal plane view of foot 200 showing a typical position for first metatarsal 210. The frontal plane, which is also known as the coronal plane, is generally considered any vertical plane that divides the body into anterior and posterior sections. On foot 200, the frontal plane is a plane that extends vertically and is perpendicular to an axis extending proximally to distally along the length of the foot. FIG. 1A shows first metatarsal 210 in a typical rotational position in the frontal plane. FIG. 1B shows first metatarsal 210 with a frontal plane rotational deformity characterized by a rotational angle 236 relative to ground, as indicated by line 238.



FIG. 2A is a top view of foot 200 showing a typical position of first metatarsal 210 in the transverse plane. The transverse plane, which is also known as the horizontal plane, axial plane, or transaxial plane, is considered any plane that divides the body into superior and inferior parts. On foot 200, the transverse plane is a plane that extends horizontally and is perpendicular to an axis extending dorsally to plantarly (top to bottom) across the foot. FIG. 2A shows first metatarsal 210 with a typical IMA 234 in the transverse plane. FIG. 2B shows first metatarsal 210 with a transverse plane rotational deformity characterized by a greater IMA caused by the distal end of first metatarsal 210 being pivoted medially relative to the second metatarsal 212.



FIG. 3A is a side view of foot 200 showing a typical position of first metatarsal 210 in the sagittal plane. The sagittal plane is a plane parallel to the sagittal suture which divides the body into right and left halves. On foot 200, the sagittal plane is a plane that extends vertically and is perpendicular to an axis extending proximally to distally along the length of the foot. FIG. 3A shows first metatarsal 210 with a typical rotational position in the sagittal plane. FIG. 3B shows first metatarsal 210 with a sagittal plane rotational deformity characterized by a rotational angle 240 relative to ground, as indicated by line 238.


A bone positioning technique according to the disclosure can be useful to correct an anatomical misalignment of a bones or bones. In some applications, the technique involves realigning a metatarsal or a portion thereof, relative to an adjacent cuneiform and/or adjacent metatarsal. The metatarsal undergoing realignment may be anatomically misaligned in the frontal plane, transverse plane, and/or sagittal plane, as illustrated and discussed with respect to FIGS. 1-3 above. Accordingly, realignment may involve releasing the misaligned metatarsal or portion thereof for realignment and thereafter realigning the metatarsal or portion in one or more planes, two or more planes, or all three planes. After suitably realigning the metatarsal or portion thereof, the metatarsal or portion thereof can be fixated to hold and maintain the realigned positioned.


While a metatarsal can have a variety of anatomically aligned and misaligned positions, in some examples, the term “anatomically aligned position” means that an angle of a long axis of first metatarsal 210 relative to the long axis of second metatarsal 212 is about 10 degrees or less in the transverse plane and/or sagittal plane. In certain embodiments, anatomical misalignment can be corrected in both the transverse plane and the frontal plane. In the transverse plane, a normal IMA 234 between first metatarsal 210 and second metatarsal 212 is less than about 9 degrees. An IMA 234 of between about 9 degrees and about 13 degrees is considered a mild misalignment of the first metatarsal and the second metatarsal. An IMA 234 of greater than about 16 degrees is considered a severe misalignment of the first metatarsal and the second metatarsal. In some embodiments, methods according to the disclosure are utilized to anatomically align first metatarsal 210 or a portion thereof by reducing the IMA from over 10 degrees to about 10 degrees or less (e.g., to an IMA of about 1-5 degrees), including to negative angles of about −5 degrees or until interference with the second metatarsal, by positioning the first metatarsal at a different angle with respect to the second metatarsal.


With respect to the frontal plane, a normal first metatarsal will be positioned such that its crista prominence is generally perpendicular to the ground and/or its sesamoid bones are generally parallel to the ground and positioned under the metatarsal. This position can be defined as a metatarsal rotation of 0 degrees. In a misaligned first metatarsal, the metatarsal is axially rotated between about 4 degrees to about 30 degrees or more. In some embodiments, methods according to the disclosure are utilized to anatomically align the metatarsal by reducing the metatarsal rotation from about 4 degrees or more to less than 4 degrees (e.g., to about 0 to 2 degrees) by rotating the metatarsal with respect to the medial cuneiform.



FIG. 4A is a flow diagram illustrating an example osteotomy technique for correcting an anatomical alignment. The technique will be described with respect to first metatarsal 210 although can be performed on other bones, as discussed above. With reference to FIG. 4A, the example technique involves making a first crescentic-shaped cut transecting metatarsal 210 (300). The first cut separates the first metatarsal 210 into two portions: a proximal portion and a distal portion. One of the portions can have a concave-shaped end with a radius corresponding to the radius of the crescentic-shaped cut while the other portion can have a corresponding concave-shaped end of the same radius. The two portions can be distracted, or separated by force, to provide opposed ends separated from each other.


The technique of FIG. 4A further involves making a second crescentic-shaped cut across the concave-shaped end of the concave-shaped bone portion (302). The second crescentic-shaped cut can be made at an offset angle relative to the first crescentic-shaped cut, providing intersecting cut arcs that define multiple intersecting concave regions on the end face of the bone. For example, second crescentic-shaped cut may be used to chamfer a dorsal-lateral quadrant of the concave-shaped bone portion, providing a second concave pocket offset from a centered concavity formed upon making the first crescentic-shaped cut. This second concave pocket may provide a region in which the convex-shaped end of the opposite bone portion can be rotated into to rotationally realign one bone portion relative to the other bone portion.


For example, the illustrated technique includes moving one bone portion relative to another bone portion to adjust an alignment of the bone portions relative to each other (304). In some examples, the distal portion of the transected first metatarsal 210 is rotated relative to the proximal portion of the transected metatarsal. The distal portion of the transected first metatarsal 210 may be rotated in the frontal plane and/or pivoted in the transverse plane and/or pivoted in the sagittal plane to help correct an anatomical misalignment of the distal portion of the metatarsal. In some examples, the distal portion of the first metatarsal 210 is rotated about an axis extending through the frontal plane so the medial side is moved dorsally and/or the distal portion of the first metatarsal 210 is moved laterally in the transverse plane and/or plantarly in the sagittal plane. For example, the distal portion of the transected first metatarsal 210 may be moved from an anatomically misaligned position relative to second metatarsal 212 and/or the medial cuneiform 222 to an anatomically aligned position. During movement, the end face of the distal portion of the first metatarsal 210 created by making the first crescentic-shaped cut can shift relative to the end face of the proximal portion of the first metatarsal created by making the cut.


In some example, the end face of the distal portion of the first metatarsal 210 created by making the first crescentic-shaped moves medially relative to the end face of the proximal portion of the first metatarsal created by making the cut. This base shift can cause the lateral side of the distal portion to move from being aligned with the lateral side of the proximal portion to being medially offset relative to the lateral face. For example, the lateral side of the distal portion of first metatarsal 210 may move into a concave pocket formed in the medial-lateral quadrant of the end face of the proximal portion of the first metatarsal by making the second crescentic-shaped cut. In these applications, the second pocket formed by making the second crescentic-shaped cut may reduce or eliminate bone-on-bone interference that may otherwise occur between the proximal and distal portions of the first metatarsal during realignment.


After suitably moving the two transected bone portions relative to each other, the bone portions can be fixated to each other to secure and hold the new realigned position achieved through movement (306). The bone portions can be fixated using pins, plates, screws, or other fixation devices to provide stability during the healing process. In one example, a bone plate is secured on the dorsal-medial side of the distal and proximal bone portions across the joint formed by transecting the first metatarsal 210 into the two bone portions. Additionally or alternatively, a bone plate may be secured on a different portion of the bones, such as helical bone plate that extends from a medial side of the distal bone portion to a plantar side of the proximal bone portion and/or from a plantar side of the distal bone portion to a medial side of the proximal bone portion. Additional details on example bone plating configurations that can be used are described in U.S. patent application Ser. No. 14/990,368, entitled “BONE PLATING SYSTEM AND METHOD” and filed on Jan. 7, 2016, the entire contents of which are incorporated herein by reference.



FIG. 4B is a flow diagram illustrating another example technique for correcting an anatomical alignment. The example technique involves making a generally spherical-shaped cut transecting a metatarsal 210 (450). The generally spherical-shaped cut separates the first metatarsal 210 into two portions: a proximal portion and a distal portion. One of the portions can have a generally spherical-shaped end while the end of the opposed bone portion can have a corresponding generally spherical-shaped socket.


To make the generally spherical-shaped cut, a generally spherical-shaped cutting instrument can be translated through an arc that transects the first metatarsal. The cutting instrument can be translated in any direction across the metatarsal, including from the dorsal to the plantar side of the metatarsal or vice versa, or the medial to the lateral side of the metatarsal or vice versa. The cutting instrument can be translated across the metatarsal such that the resulting proximal portion defines the generally spherical-shaped ball and the distal portion defines the corresponding generally spherical-shaped socket. Alternatively, the cutting instrument can be translated across the metatarsal such that the resulting distal portion defines the generally spherical-shaped ball and the proximal portion defines the corresponding generally spherical-shaped socket.


The generally spherical-shaped ends formed by making the transecting cut according to the technique of FIG. 4B may have a substantially constant radius (or, in some embodiments, constant radius) of curvature from a geometric center of the shape or may have a radius of curvature that varies across the face from the geometric center of the shape. For example, the generally spherical-shaped ends may have a parabolic or other spheroidal shape that provides one rounded end that fits into a cup-like depression of an opposed end. The generally spherical-shaped ends can be achieved using a cutting instrument with a generally spherical-shaped blade or cutting instruments having alternative shapes that are moved through the bone during transection to achieve the general spherical-shape. In some examples, a generally spherical-shaped cutting instrument is used that has a generally spherical-shaped cutting blade having a diameter ranging from 6 millimeters to 30 millimeters, although cutting blades of other dimensions can also be used. The radius of curvature of the generally spherical-shaped cutting blade may be constant across the blade or may vary by less than a threshold amount, such as plus or minus 30%, plus or minus 20%, plus or minus 10%, plus or minus 5%, or plus or minus 1%.


After cutting the first metatarsal into two portions using a generally spherical-shaped cutting instrument, the technique of FIG. 4B includes moving one bone portion relative to another bone portion to adjust an alignment of the bone portions relative to each other (452). In some examples, the distal portion of the transected first metatarsal 210 is rotated relative to the proximal portion of the transected metatarsal. The distal portion of the transected first metatarsal 210 may be rotated in the frontal plane and/or pivoted in the transverse plane and/or pivoted in the sagittal plane to help correct an anatomical misalignment of the distal portion of the metatarsal, as described herein.


After suitably moving the two transected bone portions relative to each other, the bone portions can be fixated to each other to secure and hold the new realigned position achieved through movement (452). The bone portions may or may not be provisionally fixated before being permanently fixated together. In either case, the portions can be permanently fixated using pins, plates, screws, staples or other fixation devices to provide stability during the healing process, as discussed above with respect to FIG. 4A and also discussed below with respect to FIGS. 9A-9C and 10.



FIG. 4C is a flow diagram illustrating another example osteotomy technique for correcting an anatomical alignment. The example technique involves making a crescentic-shaped cut transecting metatarsal 210 (456). The cut separates the first metatarsal 210 into a proximal portion and a distal portion. One of the portions can have a concave-shaped end with a radius corresponding to the radius of the crescentic-shaped cut while the other portion can have a corresponding concave-shaped end of the same radius. In some examples, the proximal portion has the concave-shaped end and the distal portion has the convex-shaped end. The two portions may or may not be distracted to provide opposed ends separated from each other.


The technique of FIG. 4C further involves making a transverse, planar cut across the distal bone portion (458). The transverse, planar cut removes the concave- or convex-shaped end of the distal bone portion, forming a third or intermediate bone portion having the concave- or convex-shaped end previously defined by the distal bone portion. The ends of the distal bone portion and the intermediate bone portion facing each other may be planar.


After making the transverse, planar cut across, the technique further includes moving the distal metatarsal portion relative to the proximal metatarsal portion and/or the intermediate metatarsal portion to adjust an alignment of the distal and proximal bone portions relative to each other (460). In some examples, the distal portion of the transected first metatarsal 210 may be rotated in the frontal plane and/or pivoted in the transverse plane and/or pivoted in the sagittal plane to help correct an anatomical misalignment of the distal portion of the metatarsal. For example, the distal portion and the intermediate portion may each be moved in the transverse plane relative to the proximal portion, e.g., either the same distance or different distances. In some examples, the proximal ends of the distal portion and the intermediate portion are each translated medially in the transverse plane, e.g., causing the distal ends to pivot laterally to close the IMA.


In addition to or in lieu of translating the distal portion and the intermediate portion in the transverse plane, the distal portion may be rotated relative to the intermediate portion in the frontal plane. During movement, the planar proximal end face of the distal portion can rotate relative to the planar distal end face of the intermediate portion. In some examples, the distal portion is pivoted in the sagittal plane to also adjust the alignment of the distal portion in the sagittal plane.


After suitably moving the three transected bone portions relative to each other, the bone portions can be fixated to each other to secure and hold the new realigned position achieved through movement (462). The bone portions may or may not be provisionally fixated before being permanently fixated together. In either case, the portions can be permanently fixated using pins, plates, screws, staples or other fixation devices to provide stability during the healing process, as discussed above with respect to FIG. 4A and also discussed below with respect to FIGS. 9A-9C and 10.



FIG. 4D is a flow diagram illustrating another example technique for correcting an anatomical alignment. The example technique involves making a planar cut transecting a metatarsal 210 (600). The planar cut separates the first metatarsal 210 into two portions: a proximal portion and a distal portion. Both bone portions may have planar cut end faces.


To make the planar cut, a planar cutting instrument such as a saw blade can be translated through the first metatarsal. The cutting instrument can be translated in any direction across the bone, including from the dorsal to the plantar side of the metatarsal or vice versa, or the medial to the lateral side of the metatarsal or vice versa. The cutting instrument can be translated through the first metatarsal parallel to the frontal plane or at a non-zero degree angle relative to the frontal plane. Likewise, the cutting instrument can be translated through the first metatarsal orthogonal to the transverse plane or at a non-zero degree angle relative to the transverse plane. Independent of the angle at which the planar cutting instrument is passed through the bone, the end faces formed by making the transecting cut according to FIG. 4D may be planar (e.g., non-curved).


After cutting the first metatarsal into two portions using a planar cutting instrument, the technique of FIG. 4D includes moving one bone portion relative to another bone portion in multiple planes to adjust an alignment of the bone portions relative to each other (602). In some examples, the distal portion of the transected first metatarsal 210 is rotated relative to the proximal portion of the transected metatarsal. The distal portion of the transected first metatarsal 210 may be rotated in the frontal plane and/or translated in the transverse plane and/or translated in the sagittal plane to help correct an anatomical misalignment of the distal portion of the metatarsal, as described herein.


After suitably moving the two transected bone portions relative to each other, the bone portions can be fixated to each other to secure and hold the new realigned position achieved through movement (604). The bone portions may or may not be provisionally fixated before being permanently fixated together. In either case, the portions can be permanently fixated using pins, plates, screws, staples or other fixation devices to provide stability during the healing process, as discussed above with respect to FIG. 4A and also discussed below with respect to FIGS. 9A-9C and 10.



FIGS. 5A-5D show example procedural steps that can be performed to correct an anatomical misalignment of a bone. As shown in FIG. 5A, the first metatarsal 210 is positioned in the transverse plane and defines a medial side 310, lateral side 312, dorsal side 314, and plantar side 316. To transect the first metatarsal 210, a first crescentic-shaped cut 318 can be made to form a proximal bone portion 320 and a distal bone portion 322. In different examples, the crescentic-shaped cut can make using a cutting instrument that makes a planar cut (e.g., planar blade, rotary cutter) that is translated through a curved arc or a curved-shaped cutting blade that is translated linearly to form the generally crescent-shaped cut. For example, the crescentic-shaped cutting blade may be translated parallel to the frontal plane of first metatarsal 210 (e.g., either from the dorsal to plantar side or plantar to dorsal side) to form the first crescentic-shaped cut 318.


In general, the terms crescent and crescentic are used interchangeably in this disclosure and refer to an arcuate shape having a uniform radius of curvature. The crescentic-shaped cut 318 defines new end faces separating the proximal portion 320 from the distal portion 322. In the illustration of FIG. 5B, the end face 324 of proximal portion 320 has a concave shape while the end face 326 of distal portion 322 has a corresponding convex shape. In other applications, the arc can be flipped so the end face 324 of proximal portion 320 has the convex shape while the end face 326 of distal portion 322 has the corresponding concave shape.


While the crescentic-shaped cut 318 can be made at any location along the length of first metatarsal 210, in some examples, the cut is made on the proximal portion of the metatarsal. For example, the crescentic-shaped cut 318 may be made on the proximal-most half of the first metatarsal 210, such as the proximal-most quarter, or proximal-most eighth of the first metatarsal. Positioning the crescentic-shaped cut 318 closer to the TMT joint may be useful to position the center of rotation, or Center of Rotational Angulation (“CORA”), formed between the proximal portion 320 and distal portion 322, farther back proximally along the length of foot 200 to approach a more anatomically correct alignment.


With reference to FIG. 5C, the distal portion 322 of the first metatarsal 210 can be distracted, or separated, from the proximal portion 320 of the metatarsal to expose the end faces of the respective bone portions. Thereafter, a second crescentic-shaped cut 328 can be made across the concave-shaped end face to create a second concavity 332 intersecting with a first concavity 330 formed by making the first crescentic-shaped cut 318. The second crescentic-shaped cut 328 may remove a section of bone to allow the end face of the distal bone portion 322 to be shifted in the medial direction 310 to realign the bone portion in one or more planes relative to proximal portion 320.


In some examples, the second crescentic-shaped cut 328 is formed by rotating the cutting instrument in the frontal plane relative to the position of the cutting instrument when making the first crescentic-shaped cut 318. Thereafter, the cutting instrument can be translated across the bone, e.g., causing the cutting instrument to form the second crescentic-shaped cut 328 at an angle relative to the angle at which the first crescentic-shaped cut 318 was made. FIGS. 6 and 7 are perspective and frontal views, respectively, showing overlapping arcuate cuts that can be made to form the first and second crescentic-shaped cuts 318 and 328, respectively. The arcuate cuts are shown overlapping on a unitary first metatarsal 210 for purposes of illustration although in practice, one of the cuts (either the first crescentic-shaped cut 318 or second crescentic-shaped cut 328) will be made to separate the metatarsal into two portions followed by the other of the two cuts.


In FIGS. 6 and 7, the first and second crescentic-shaped cuts 318 and 328 are made relative to a sagittal plane 340, a transverse plane 342, and a frontal plane 344. The sagittal plane 340 extends in the proximal to distal direction along the length of first metatarsal 210 and bisects metatarsal in the dorsal 314 to plantar 316 directions. The transverse plane 342 extends in the proximal to distal direction along the length of first metatarsal 210 and bisects metatarsal in medial 310 to lateral 312 directions. The frontal plane 344 transects the first metatarsal 210 at one particular location along the length of the metatarsal in the proximal to distal direction.


In the illustrated example, the first crescentic-shaped cut 318 is made parallel to the frontal plane 344, e.g., perpendicular to the transverse plane 342. However, the first crescentic-shaped cut 318 can be angled in the sagittal plane 340 (either in the proximal-to-distal direction or distal-to-proximal direction), such as an angle ranging from 2 degrees to 15 degrees relative to the frontal plane 344, such as from 5 degrees to 10 degrees relative to the frontal plane.


The second crescentic-shaped cut 328 may be made at an angle relative to the transverse plane 342. For example, the second crescentic-shaped cut 328 may be made at an acute angle 348 relative to the transverse plane. In some examples, the acute angle ranges from 10 degrees to 35 degrees, such as from 15 degrees to 25 degrees, or from 18 degrees to 23 degrees. The second crescentic-shaped cut 328 may be made in the same frontal plane as the frontal plane in which the first crescentic-shaped cut 318 is made or may be offset. For example, the second crescentic-shaped cut 328 may be at an angle ranging from 2 degrees to 15 degrees relative to the frontal plane 344, such as from 5 degrees to 10 degrees relative to the frontal plane.



FIGS. 8A and 8B show frontal views of the proximal bone portion 320 at different stages of the example osteotomy technique. FIG. 8A illustrates the end face of proximal bone portion 320 after the first cut but prior to the second cut, resulting in the first concavity 330. The curvature of first crescentic-shaped cut 318 is illustrated in FIG. 8A overlaying the end face to show how the curvature has been formed by the generally crescent-shaped cut. FIG. 8B illustrates the end face of proximal bone portion 320 after the second cut, resulting in second concavity 332. The curvature of second crescentic-shaped cut 328 is illustrated in FIG. 8B overlaying the end face to show how the curvature has intersected with the curvature of the first cut. As shown in this example, a section of bone in a dorsal lateral quadrant of the end face has been removed by the second crescentic-shaped cut 328, thereby forming a second pocket or saddle (second concavity 332) that intersects with the main pocket or saddle (first concavity 330) formed by the first cut.


In practice, the same cutting instrument (e.g., having the same radius of curvature) used to form the first crescentic-shaped cut 318 may be used to form the second crescentic-shaped cut 328. Alternatively, a different sized and/or shaped cutting instrument may be used to form the second crescentic-shaped cut 328 from that used to form the first cut. In some examples, the cutting instrument used to form the first and/or second crescentic-shaped cuts 318, 328 has a radius of curvature ranging from 3 millimeters to 15 millimeters.


After forming the first and second crescentic-shaped cuts 318, 328, the clinician may move one bone portion (e.g., distal portion 322) relative to another bone portion (e.g., proximal portion 320) to realign that bone portion relative to the medial cuneiform 222 and/or an adjacent metatarsal, such as second metatarsal 212 (FIGS. 1A and 2A). For example, as discussed above with respect to FIG. 4A, the distal portion 322 of the transected first metatarsal 210 may be moved from an anatomically misaligned position relative to second metatarsal 212 and/or the medial cuneiform 222 to an anatomically aligned position. During movement, the end face of the distal portion 322 of the first metatarsal 210 created by making the first crescentic-shaped cut 318 can shift relative to the end face of the proximal portion 320 of the first metatarsal created by making the cut.


In some examples, the lateral side of the end face of the distal portion 322 is repositioned in contact with a portion of end face of proximal portion 320 created by making the second crescentic-shaped cut 328. FIGS. 9A and 9B illustrate exemplary movement of a distal portion 322 relative to a proximal portion 320, e.g., to reduce the IMA in the transverse plane and/or reduce the extent of angular deformity in the frontal and/or sagittal planes. FIG. 9A illustrates example movement of distal portion 322 relative to proximal portion 320 to correct a comparatively minor deformity while FIG. 9B illustrates example movement for a more severe deformity.


To reposition the distal portion 322 relative to the proximal portion 320 in the example of FIGS. 9A and 9B, the distal portion 322 can be rotated in the frontal plane about an axis 350 extending parallel to the length of the metatarsal 210. Rotation of distal portion 322 about axis 350 can cause the proximal end of the distal portion to rotate into the second saddle or concavity 332 (illustrated on FIG. 8B) formed by making the second crescentic-shaped cut 328. In some examples, the distal portion 322 is rotated relative to the proximal portion 320 until the sagittal plane 340 bisects the crista prominence 346 on the plantar side of the foot, as illustrated in FIG. 7. Additionally or alternatively, the distal portion 322 can be pivoted in the transverse plane (e.g., such that the distal end of the distal portion is translated from the medial to lateral direction) to close the IMA. Further additionally or alternatively, the distal portion 322 may be pivoted in the sagittal plane (e.g., such that the distal end of the distal portion is translated plantarly or dorsally) to correct a sagittal plane misalignment.


In some applications, the distal portion 322 is moved in multiple planes (2 or 3 planes) relative to the proximal portion 320 to move the distal portion from an anatomically misaligned position to an anatomically aligned position. With respect to the frontal plane, a normal first metatarsal will be positioned such that its crista prominence 346 (FIG. 7) is generally perpendicular to the ground (e.g., bisected by the sagittal plane) and/or its sesamoid bones are generally parallel to the ground and positioned under the metatarsal. This position can be defined as a metatarsal rotation of 0 degrees. In a misaligned first metatarsal, the metatarsal may be axially rotated between about 4 degrees to about 30 degrees or more. Accordingly, in some applications, the distal portion 322 is moved relative to the proximal portion 320 to anatomically align the distal portion by reducing the metatarsal rotation in the frontal plane from about 4 degrees or more to less than 4 degrees (e.g., to about 0 to 2 degrees) by rotating the distal portion 322 with respect to the proximal portion 320.


In an anatomically misaligned metatarsal, the hallux sesamoid bones in the foot of the patient may be rotated relative to their normal, anatomically-aligned position. The hallux sesamoids are two ovoid-shaped ossicles within the flexor hallucis brevis muscles where the muscles pass over the metatarsophalangeal joint (joint 232 in FIG. 2A) between the first metatarsal 210 and proximal phalanx 220. There is a tibial hallux sesamoid and a fibular hallux sesamoid. FIG. 9C is a frontal plane view of first metatarsal 210 showing an example frontal plane rotational misalignment of the two sesamoid bones 352. In some examples, the distal portion 322 is rotated in the frontal plane until the sesamoids 352 are generally parallel to the ground and positioned under the metatarsal, e.g., bisected by the sagittal plane. Repositioning of the sesamoids after an example rotational realignment in the frontal plane is illustrated in FIG. 9D. Additional details on rotation correction techniques for bone portions that can be used in accordance with the disclosure are described in U.S. patent application Ser. No. 14/981,335, entitled “BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS” and filed on Dec. 28, 2015, the entire contents of which are incorporated herein by reference.


In some examples, a clinician performing an anatomical realignment according to the disclosure (for example, using one or more of the cutting techniques described with respect to FIGS. 4A-4D), may use imaging equipment within the operating suit to help visualize and guide the realignment process. For example, the clinician may use fluoroscopy to visualize the positioning of bones during one or more portions of the realignment technique, such as during cutting and/or while realigning a distal bone portion relative to a proximal bone portion. To aid visualization and/or movement of one bone portion relative to another bone portion, the clinician may insert one or more pins (e.g., metal rods) into the bone before or after making a transecting cut.


In some examples, the clinician inserts a pin into the distal portion of the bone before making a transecting cut (e.g., using a planar, crescentic, spherical, or other shaped cutting instrument). Additionally or alternatively, the clinician may insert a pin into the proximal portion of the bone before making the transecting cut. As alternatives, one or both pins may be inserted after making the transecting cut, although it may be procedurally simpler to insert the pin(s) before making the cut. The clinician may insert the pin in the distal portion so the tip of the pin is inserted at an angle in the lateral-plantar direction into the bone. This may result in the head of the pin projecting out of the bone in the medial-dorsal quadrant. Other insertion directions can be used.


After making the transecting cut, the clinician may use the pin as a guiding instrument to facilitate movement of the distal bone portion relative to the proximal bone portion. For example, the clinician may apply a translating force and/or a rotary force to the pin, optionally while observing the amount of movement under fluoroscopic imaging, to guide the distal bone portion to a suitably realigned position. The clinician may use the anatomical standards and/or landmarks described above to determine when the distal bone portion has been suitably realigned. In some examples, the distal bone portion is rotated until the sesamoid bones on the distal portion are centered plantarly. Example anatomical landmarks are described below with respect to FIGS. 18A and 18B.


After suitably moving the distal and proximal bone portions 322, 320 relative to each other, the bone portions may be fixated to provide a stable orientation during healing. In some examples, the distal and proximal bone portions 322, 320 are provisionally fixated relative to each other before permanently fixating the bone portions relative to each other. Provisional fixation can temporarily hold the proximal bone portion 320 and distal bone portion 322 in fixed alignment relative to each other while one or more permanent fixation devices are applied to the bones and across the joint formed therebetween. To provisionally fixate the bone portions relative to each other, a fixation wire may be driven in the proximal bone portion 320 and distal bone portion 322. Additionally, or alternatively, a compression pin, such as a threaded olive pin, may be inserted through the proximal portion 320 and into the distal portion 322, or vice versa, to provide compression and provisional fixation between the two bone portions.


Independent of whether the proximal bone portion 320 and distal bone portion 322 are provisionally fixated together, the clinician may apply a permanent fixation device to the bone portions and across the joint between the bone portions. The permanent fixation device can hold the bone portions in fixed alignment relative to each other, e.g., to promote healing between the bone portions in their aligned positions. In different examples, one or more bone plates, pins, screws, staples, or other fixation mechanisms can be used to fixate the bones relative to each other. FIG. 10 illustrates an example configuration of a bone plate 400 that may be used to bridge the joint formed between the proximal portion and the distal portion of the first metatarsal. When using a bone plate, a variety of different shaped bone plates can be used, including helical-shaped bone plates, T-shaped bone plates, and L-shaped bone plates.


Additionally, while different cutting hardware can be used to execute an osteotomy technique according to the disclosure, FIG. 10 illustrates one example cutting guide 410 that may be useful to perform the technique. As shown, cutting guide 410 includes a seeker portion 420 projecting plantarly from a main body 430. The seeker portion may be configured (e.g., sized and/or shaped) to be inserted in a TMT joint between first metatarsal 210 and medial cuneiform 222, thereby providing a comparatively stable and fixed platform from which to guide cutting. The main body 430 of cutting guide 410 extends distally along first metatarsal 210 and may define a guide surface along with a cutting instrument 440 can be translated to perform one or more cuts as described herein.


As yet another example, an osteotomy correction technique may be performed using a combination of a crescentic-shaped cut and a planar (e.g., non-curved) cut. FIGS. 11A-11C show example procedural steps that can be performed to correct an anatomical misalignment of a bone using a combination of crescentic-shaped and planar cuts. As shown in FIG. 11A, the first metatarsal 210 can be transected by making a crescentic-shaped cut 318 to form a proximal bone portion 320 and a distal bone portion 322, as discussed above with respect to FIGS. 5A-5D. In different examples, the crescentic-shaped cut 318 can be made using a cutting instrument that makes a planar cut (e.g., planar blade, rotary cutter) that is translated through a curved arc or a curved-shaped cutting blade that is translated linearly to form the generally crescent-shaped cut. In some examples, the crescentic-shaped cut 318 is made so the end face 324 of proximal portion 320 has a concave shape while the end face 326 of distal portion 322 has a corresponding convex shape.


With reference to FIG. 11B, a planar cut 470 can be made across the distal portion 322 to form an intermediate bone portion 472. The planar cut 470 can be made prior to making the crescentic-shaped cut 318 or after making the crescentic-shaped cut. In either case, the planar cut 470 can form a new planar end face 474 on the proximal end of the distal portion 322. This can cause the crescentic-shaped end face 324 previously defined by the distal portion 322 to become the proximal end face of the newly formed intermediate portion 472. The distal end face 476 of the intermediate portion 472 may be planar, corresponding to the planar end face 474 on the distal portion 322.


The planar cut 470 can be made by translating a cutting instrument through the distal portion 322. The planar cut 470 may be offset from the crescentic-shaped end face 324 formed by making the crescentic-shaped cut 318 (or that will be formed upon subsequently making the crescentic-shaped cut in instances where the planar cut is made first). In some examples, the planar cut 470 is offset from the terminal edge 478 of the crescentic-shaped end face 324 a distance 480 ranging from 2 to 30 millimeters, such as from 7 to 25 millimeters.


In the illustrated example, the planar cut 470 is made parallel to the frontal plane, e.g., perpendicular to the transverse plane. However, the planar cut can be angled in the sagittal plane (either in the proximal-to-distal direction or distal-to-proximal direction), such as an angle ranging from 2 degrees to 15 degrees relative to the frontal plane 344, such as from 5 degrees to 10 degrees relative to the frontal plane.


To adjust the anatomical alignment of the distal portion 322 relative to the proximal portion 320 and/or intermediate portion 472, the distal portion can be moved. In some examples as illustrated in FIG. 11C, the distal portion 322 and intermediate portion 472 are translated in the transverse plane. The distal portion 322 and intermediate portion 472 can be pivoted in the transverse plane (e.g., such that the distal end of the distal portion is translated from the medial to lateral direction) to close the IMA. As the distal portion 322 and intermediate portion 472 are pivoted, the crescentic-shaped end face 324 of the intermediate portion can translate along the arc of the corresponding crescentic-shaped end face 326 of the proximal portion. The planar end faces 474 and 476 of the intermediate and distal portions may not move relative to each other during this pivoting movement.


Additionally or alternatively, the distal portion 322 can be rotated in the frontal plane about an axis 350 extending parallel to the length of the metatarsal 210. Rotation of distal portion 322 about axis 350 can cause the planar end face 474 on the proximal end of the distal portion 322 to rotate relative to the planar end face 476 on the intermediate portion, which may remain rotationally stationary during movement. In some examples, the distal portion 322 is rotated relative to the intermediate portion 472 and proximal portion 320 until the sagittal plane 340 bisects the crista prominence 346 on the plantar side of the foot, as illustrated in FIG. 7. Further additionally or alternatively, the distal portion 322 may be pivoted in the sagittal plane (e.g., such that the distal end of the distal portion is translated plantarly or dorsally) to correct a sagittal plane misalignment. The distal portion 322 can be moved relative to the intermediate bone portion 472 and/or proximal bone portion 320 to achieve any of the anatomical alignment positions described herein.


After suitably moving the distal bone portion 322, proximal bone portion 320, and intermediate bone portion 472 relative to each other, the bone portions may be fixated to provide a stable orientation during healing. In some examples, the distal, intermediate, and proximal bone portions 322, 472, 320 are provisionally fixated relative to each other before permanently fixating the bone portions relative to each other. In either case, a clinician may apply a permanent fixation device to the three bone portions and across the two joints between the three bone portions. In different examples, one or more bone plates, pins, screws, staples, or other fixation mechanisms can be used to fixate the bones relative to each other.



FIG. 12 illustrates an example fixation arrangement that includes a first bone plate 490 and a second bone plate 492. The bone plates bridge the joint formed between the distal portion and the intermediate portion as well as the joint formed between the intermediate portion and the proximal portion. In some examples, a bone plate is secured on the dorsal-medial side of the distal, intermediate, and proximal bone portions across the joints formed by transecting the first metatarsal 210 into the three bone portions. Additionally or alternatively, a bone plate may be secured on a different portion of the bones.


While the foregoing discussion has generally described osteotomy techniques involving multiple crescentic-shaped cuts, it should be appreciated that the techniques may be performed without making multiple crescentic-shaped cuts in other applications. For example, in instances where a generally spherical-shaped cutting instrument is used, a single cut may be made to transect the first metatarsal 210 and define the ends of the respective bone portions.



FIG. 13 is an illustration of an example generally spherical-shaped cutting blade 500 that can be used to transect a metatarsal during a bone realignment procedure. In use, the generally spherical-shaped cutting blade 500 may be translated through an arc tracing the surface of an imaginary sphere to form the generally spherical-shaped cut. The cutting blade can form one metatarsal portion having a generally spherical-shaped projection and an opposed metatarsal portion having a generally spherical-shaped recess. When used, the generally spherical-shaped cutting blade 500 can have a diameter ranging from 6 millimeters to 30 millimeters, although cutting blades of other dimensions can also be used.



FIGS. 14A and 14B are illustrations of example end faces formed by transecting a first metatarsal with generally spherical-shaped cutting blade 500. FIG. 14A illustrates an example proximal portion 320 having a concave or socket end face 502. FIG. 14B illustrates an example distal portion 322 having a convex or ball end face 504. The end faces illustrated in FIGS. 14A and 14B can be created be positioning the CORA of the generally spherical-shaped cutting blade 500 over the first metatarsal and thereafter translating the blade through the bone, e.g., from a medial to lateral direction or vice versa. In other applications, the generally spherical-shaped cutting blade 500 may be positioned such that the proximal portion 320 resulting after the cut has the convex or ball end face while the distal portion 322 has the concave or socket end face. This reverse orientation can be achieved by positioning the CORA of the generally spherical-shaped cutting blade 500 over the medial cuneiform and thereafter translating the blade through the first metatarsal, e.g., from a medial to lateral direction or vice versa. In yet other applications, the CORA of the generally spherical-shaped cutting blade 500 can be positioned over either the first metatarsal or the medial cuneiform and the blade translated through the first metatarsal from a dorsal to a plantar direction.



FIGS. 15A-15D illustrate example osteotomy procedure steps that may be performed to realign a bone or bone portion using a planar cutting instrument according to the technique of FIG. 4D. FIG. 15A is a dorsal to plantar view of a first metatarsal 210 with an example frontal-plane rotation and transverse-plane medial deviation, resulting in an increased IM angle. A guide pin 650 has been inserted in the distal head of the metatarsal in preparation for further surgical procedure steps. FIG. 15B illustrates an example planar osteotomy cut line 652 though which a planar cutting instrument is passed to transect the metatarsal 210 into a distal portion and a proximal portion. FIG. 15C illustrates an example frontal-plane rotational correction that can be applied to the distal bone portion. The clinician may grasp the guide pin 650 and use the guide pin to correct the rotation of the distal metatarsal segment in the frontal-plane. In some examples, the clinician visualizes the rotational realignment and use the rotational position of guide pin 650 to visually guide the degree of rotational correction applied to the distal metatarsal portion. In addition, FIG. 15D illustrates an example lateral translation that can be applied to the distal bone portion, either before, after, or concurrent with rotating the distal bone portion in the frontal plane (FIG. 15C). The distal bone portion can be translated laterally in the transverse plane to address the transverse-plane medial deviation of the metatarsal, helping to reduce or eliminate the bunion “bump”. Although not illustrated, the distal bone portion can be translated in the sagittal plane in addition to or in lieu of translating the bone portion in the transverse plane.


The clinician may visually monitor the position of guide pin 650 and use the position of the pin (e.g., the angle of rotation of the pin) to determine when the distal bone portion is adequately realigned. Additionally, or alternatively, the clinician may view the position of guide pin 650 and/or the position of one or more anatomical landmarks on the distal bone portion under fluoroscopy to determine when the distal bone portion is adequately realigned. Once suitably realigned, the clinician may provisionally and/or permanently fixate the realigned distal bone portion to the proximal bone portion, as discussed above.



FIGS. 16A and 16B are example images showing how a guide pin can be used to help facilitate realignment of one bone portion relative to another bone portion. FIG. 16A illustrates a first metatarsal 210 having frontal-plane rotation deviation. A guide pin 650 is inserted into the metatarsal. The rotational position of guide pin 650 can be used by the clinician to help visually determine (e.g., with the unaided eye or under fluoroscopic imaging) when the portion of the first metatarsal being rotationally realigned has been suitably rotated in the frontal plane. In some examples, the clinician also uses guide pin 650 as a grasping instrument to manually grasp the pin and rotate the bone portion being realigned. FIG. 16B illustrates how the portion of first metatarsal 210 containing guide pin 650 has been rotationally realigned in the frontal plane. The angle of the guide pin 650 has rotated dorsally with rotation of the first metatarsal 210 and the sesamoid bones of have been centered plantarly under the metatarsal. In some examples, the first metatarsal 210 may translated in the transverse and/or sagittal plane in addition to being rotated in the frontal plane.



FIGS. 17A and 17B are additional example images showing how guide pins can be used to help facilitate realignment of one bone portion relative to another bone portion. FIG. 17A illustrates a first metatarsal 210 having frontal-plane rotation deviation. A first guide pin 650A is inserted into the metatarsal (e.g., in a distal portion of the metatarsal) while a second guide pin 650B is inserted proximally of the first guide pin (e.g., in a proximal portion of the metatarsal and/or medial cuneiform). The clinician can use the relative rotational positions of first and second guide pins 650A and 650B to help visually guide realignment of the distal portion of the first metatarsal (e.g., with the unaided eye and/or under fluoroscopic imaging). FIG. 17B illustrates how the portion of first metatarsal 210 containing first guide pin 650A has been rotationally realigned in the frontal plane relative to the second guide pin 650B. The angle of the first guide pin 650A has rotated dorsally into alignment with the second guide pin 650B. In some examples, the first metatarsal 210 may translated in the transverse and/or sagittal plane in addition to being rotated in the frontal plane.



FIGS. 18A and 18B are fluoroscopic images showing example anatomical landmarks on a distal portion of a first metatarsal that a clinician may monitor (e.g., with the aid of fluoroscopy) to determine when the distal portion is suitably realigned relative to the proximal portion of the metatarsal. FIG. 18A is a fluoroscopic image taken from the dorsal-to-plantar direction showing a first metatarsal 210 that is misaligned in at least the frontal plane. In this example, the distal metatarsal head is characterized by a lateral rounding 670 in the transverse plane (the plane in the plane of the image), which is attributable to the frontal plane misalignment. As illustrated, the lateral rounding is the profile of the plantar condyles that come into view in the anterior-posterior projection with metatarsal frontal-plane rotation. Further, FIG. 18A illustrates that the sesamoid bones 672 are rotated laterally, also attributable to the frontal plane misalignment.



FIG. 18B is a fluoroscopic image taken from the dorsal-to-plantar direction showing the first metatarsal 210 from FIG. 18A that has been realigned in multiple planes. As shown, the lateral side 670 of the distal metatarsal head is substantially planar in the sagittal plane. In addition, the sesamoid bones 672 have rotated medially and are positioned substantially centered plantarly under the distal portion of the first metatarsal. Accordingly, FIGS. 18A and 18B illustrate that the profile of the metatarsal head and/or the position of the sesamoid bones are anatomical landmarks visible using fluoroscopy that a clinician can use to control realignment and determine when a distal bone portion is adequately realigned.


Various examples have been described. These and other examples are within the scope of the following claims.

Claims
  • 1. A method comprising: using a guide surface of a cutting guide to guide a cutting instrument to cut a first metatarsal, the cutting instrument cutting the first metatarsal into a proximal metatarsal portion and a distal metatarsal portion;inserting a guide pin into the distal metatarsal portion;moving the distal metatarsal portion in at least a frontal plane and a transverse plane relative to the proximal metatarsal portion, to correct bunion deformity by adjusting an alignment of the distal metatarsal portion relative to the proximal metatarsal portion, wherein moving the distal metatarsal portion comprises moving the distal metatarsal portion in at least the frontal plane by applying a rotational force to the guide pin; andfixating an adjusted position of the distal metatarsal portion relative to the proximal metatarsal portion by applying at least one fixation device.
  • 2. The method of claim 1, wherein moving the distal metatarsal portion in the frontal plane comprises rotating the distal metatarsal portion until a tibial sesamoid bone and a fibular sesamoid bone are on opposite sides of a sagittal plane when viewed from the frontal plane.
  • 3. The method of claim 1, wherein moving the distal metatarsal portion in the transverse plane comprises shifting the distal metatarsal portion laterally in the transverse plane.
  • 4. The method of claim 1, wherein moving the distal metatarsal portion in the transverse plane comprises pivoting the distal metatarsal portion laterally in the transverse plane.
  • 5. The method of claim 1, wherein moving the distal metatarsal portion in at least the frontal plane and the transverse plane further comprises moving the distal metatarsal portion in a sagittal plane.
  • 6. The method of claim 1, wherein fixating the adjusted position of the distal metatarsal portion relative to the proximal metatarsal portion by applying at least one fixation device comprises applying at least one of a bone plate, a pin, a screw, and a staple across a joint separating the distal metatarsal portion from the proximal metatarsal portion.
  • 7. The method of claim 1, wherein fixating the adjusted position of the distal metatarsal portion relative to the proximal metatarsal portion by applying at least one fixation device comprises applying at least one bone plate across a joint separating the distal metatarsal portion from the proximal metatarsal portion.
  • 8. The method of claim 7, wherein the at least one bone plate comprises a bone plate selected from the group consisting of a helical-shaped bone plate, a T-shaped bone plate, and an L-shaped bone plate.
  • 9. The method of claim 1, wherein using the guide surface of the cutting guide to guide the cutting instrument to cut the first metatarsal, the cutting instrument cutting the first metatarsal into the proximal metatarsal portion and the distal metatarsal portion comprises making at least one of a planar cut, a generally spherical-shaped cut, and a crescentic-shaped cut transecting the first metatarsal.
  • 10. The method of claim 1, wherein cutting the first metatarsal into a proximal metatarsal portion and a distal metatarsal portion comprises making a planar cut transecting the first metatarsal.
  • 11. The method of claim 1, further comprising, prior to using the guide surface of the cutting guide, aligning the cutting guide relative to the first metatarsal.
  • 12. The method of claim 1, wherein the cutting guide comprises a seeker, and aligning the cutting guide comprising inserting the seeker into a tarsometatarsal joint between the first metatarsal and a medial cuneiform.
  • 13. The method of claim 1, wherein inserting the guide pin into the distal metatarsal portion comprises inserting the guide pin into the distal metatarsal portion after cutting the first metatarsal into the proximal metatarsal portion and the distal metatarsal portion.
  • 14. The method of claim 13, wherein the guide pin comprises a distal guide pin and further comprising inserting a proximal guide pin into the proximal metatarsal portion.
  • 15. The method of claim 14, wherein moving the distal metatarsal portion comprises visualizing the distal metatarsal portion and the proximal metatarsal portion under fluoroscopy and monitoring a position of one or more anatomical landmarks visible under fluoroscopy to control adjustment of the distal metatarsal portion.
  • 16. A method comprising: positioning a guide surface of a cutting guide over a portion of a first metatarsal to be cut, the cutting guide comprising a seeker offset a distance from the guide surface, wherein positioning the guide surface of the cutting guide over the portion of the first metatarsal to be cut comprises inserting the seeker into a joint defined by an end of the first metatarsal;guiding a cutting instrument along the guide surface to cut the first metatarsal into a proximal metatarsal portion and a distal metatarsal portion;inserting a guide pin into the distal metatarsal portion;moving the distal metatarsal bone portion in at least a frontal plane and a transverse plane relative to the proximal metatarsal bone portion, to correct bunion deformity by adjusting an alignment of the distal metatarsal portion relative to the proximal metatarsal portion, wherein moving the distal metatarsal portion comprises moving the distal metatarsal portion in at least the frontal plane by applying a rotational force to the guide pin; andfixating an adjusted position of the distal metatarsal portion relative to the proximal metatarsal portion by applying at least one fixation device.
  • 17. The method of claim 16, wherein moving the distal metatarsal portion in the transverse plane comprises shifting the distal metatarsal portion laterally in the transverse plane.
  • 18. The method of claim 16, wherein moving the distal metatarsal portion in the transverse plane comprises pivoting the distal metatarsal portion laterally in the transverse plane.
  • 19. The method of claim 16, wherein guiding the cutting instrument along the guide surface to cut the first metatarsal into the proximal metatarsal portion and the distal metatarsal portion comprises making at least one of a planar cut, a generally spherical-shaped cut, and a crescentic-shaped cut transecting the first metatarsal.
  • 20. The method of claim 1, wherein inserting the guide pin comprises inserting the guide pin such that the guide pin projects out of a medial-dorsal quadrant of the distal metatarsal portion.
  • 21. The method of claim 1, wherein using the guide surface of the cutting guide to guide the cutting instrument to cut the first metatarsal, the cutting instrument cutting the first metatarsal into the proximal metatarsal portion and the distal metatarsal portion comprises making a planar cut across the first metatarsal parallel to the frontal plane.
  • 22. The method of claim 16, wherein moving the distal metatarsal portion comprises visualizing the distal metatarsal portion and the proximal metatarsal portion under fluoroscopy and monitoring a position of one or more anatomical landmarks visible under fluoroscopy to control adjustment of the distal metatarsal portion.
CROSS-REFERENCE

This application is a continuation of U.S. patent application Ser. No. 15/687,994, filed Aug. 28, 2017, which claims the benefit of U.S. Provisional Patent Application No. 62/380,074, filed Aug. 26, 2016. The entire contents of each of these applications are incorporated herein by reference.

US Referenced Citations (394)
Number Name Date Kind
2557364 Tillson Jun 1951 A
2737835 Herz Mar 1956 A
3159952 Lipkins Dec 1964 A
4069824 Weinstock Jan 1978 A
4159716 Borchers Jul 1979 A
4187840 Watanabe Feb 1980 A
4335715 Kirkley Jun 1982 A
4338927 Volkov et al. Jul 1982 A
4349018 Chambers Sep 1982 A
4409973 Neufeld Oct 1983 A
4440168 Warren Apr 1984 A
4501268 Comparetto Feb 1985 A
4502474 Comparetto Mar 1985 A
4509511 Neufeld Apr 1985 A
4565191 Slocum Jan 1986 A
4570624 Wu Feb 1986 A
4627425 Reese Dec 1986 A
4628919 Clyburn Dec 1986 A
4632102 Comparetto Dec 1986 A
4664102 Comparetto May 1987 A
4677973 Slocum Jul 1987 A
4708133 Comparetto Nov 1987 A
4750481 Reese Jun 1988 A
4754746 Cox Jul 1988 A
4757810 Reese Jul 1988 A
4787908 Wyss et al. Nov 1988 A
4895141 Koeneman et al. Jan 1990 A
4952214 Comparetto Aug 1990 A
4978347 Ilizarov Dec 1990 A
4988349 Pennig Jan 1991 A
4995875 Coes Feb 1991 A
5021056 Hofmann et al. Jun 1991 A
5035698 Comparetto Jul 1991 A
5042983 Rayhack Aug 1991 A
5049149 Schmidt Sep 1991 A
5053039 Hofmann et al. Oct 1991 A
5078719 Schreiber Jan 1992 A
5112334 Alchermes et al. May 1992 A
5147364 Comparetto Sep 1992 A
5176685 Rayhack Jan 1993 A
5207676 Canadell et al. May 1993 A
5246444 Schreiber Sep 1993 A
5254119 Schreiber Oct 1993 A
5312412 Whipple May 1994 A
5358504 Paley et al. Oct 1994 A
5364402 Mumme et al. Nov 1994 A
5413579 Tom Du Toit May 1995 A
5417694 Marik et al. May 1995 A
5449360 Schreiber Sep 1995 A
5470335 Du Toit Nov 1995 A
5490854 Fisher et al. Feb 1996 A
5529075 Clark Jun 1996 A
5540695 Levy Jul 1996 A
5578038 Slocum Nov 1996 A
5586564 Barrett et al. Dec 1996 A
5601565 Huebner Feb 1997 A
5613969 Jenkins, Jr. Mar 1997 A
5620442 Bailey et al. Apr 1997 A
5620448 Puddu Apr 1997 A
5643270 Combs Jul 1997 A
5667510 Combs Sep 1997 A
H1706 Mason Jan 1998 H
5722978 Jenkins Mar 1998 A
5749875 Puddu May 1998 A
5765648 Sheehan et al. Jun 1998 A
5779709 Harris et al. Jul 1998 A
5788695 Richardson Aug 1998 A
5803924 Oni et al. Sep 1998 A
5810822 Mortier Sep 1998 A
5843085 Graser Dec 1998 A
5893553 Pinkous Apr 1999 A
5911724 Wehrli Jun 1999 A
5928234 Manspeizer Jul 1999 A
5935128 Carter et al. Aug 1999 A
5941877 Viegas et al. Aug 1999 A
5951556 Faccioli et al. Sep 1999 A
5980526 Johnson et al. Nov 1999 A
5984931 Greenfield Nov 1999 A
6007535 Rayhack et al. Dec 1999 A
6027504 McGuire Feb 2000 A
6030391 Brainard et al. Feb 2000 A
6162223 Orsak et al. Dec 2000 A
6171309 Huebner Jan 2001 B1
6203545 Stoffella Mar 2001 B1
6248109 Stoffella Jun 2001 B1
6391031 Toomey May 2002 B1
6478799 Williamson Nov 2002 B1
6511481 Von Hoffmann et al. Jan 2003 B2
6547793 McGuire Apr 2003 B1
6676662 Bagga et al. Jan 2004 B1
6719773 Boucher et al. Apr 2004 B1
6743233 Baldwin et al. Jun 2004 B1
6755838 Trnka Jun 2004 B2
6796986 Duffner Sep 2004 B2
6859661 Tuke Feb 2005 B2
7018383 McGuire Mar 2006 B2
7033361 Collazo Apr 2006 B2
7097647 Segler et al. Aug 2006 B2
7112204 Justin et al. Sep 2006 B2
7153310 Ralph et al. Dec 2006 B2
7182766 Mogul Feb 2007 B1
7241298 Nemec et al. Jul 2007 B2
7282054 Steffensmeier et al. Oct 2007 B2
7377924 Raistrick et al. May 2008 B2
7465303 Riccione et al. Dec 2008 B2
7540874 Trumble et al. Jun 2009 B2
7572258 Stiernborg Aug 2009 B2
7641660 Lakin et al. Jan 2010 B2
D610257 Horton Feb 2010 S
7686811 Byrd et al. Mar 2010 B2
7691108 Lavallee Apr 2010 B2
7763026 Egger et al. Jul 2010 B2
D629900 Fisher Dec 2010 S
7967823 Ammann et al. Jun 2011 B2
7972338 O'Brien Jul 2011 B2
D646389 Claypool et al. Oct 2011 S
8057478 Kuczynski et al. Nov 2011 B2
8062301 Ammann et al. Nov 2011 B2
D651315 Bertoni et al. Dec 2011 S
D651316 May et al. Dec 2011 S
8080010 Schulz et al. Dec 2011 B2
8083746 Novak Dec 2011 B2
8123753 Poncet Feb 2012 B2
8137406 Novak et al. Mar 2012 B2
8147530 Strnad et al. Apr 2012 B2
8167918 Strnad et al. May 2012 B2
8172848 Tomko et al. May 2012 B2
8192441 Collazo Jun 2012 B2
8197487 Poncet et al. Jun 2012 B2
8231623 Jordan Jul 2012 B1
8231663 Kay et al. Jul 2012 B2
8236000 Ammann et al. Aug 2012 B2
8246561 Agee et al. Aug 2012 B1
D666721 Wright et al. Sep 2012 S
8262664 Justin et al. Sep 2012 B2
8277459 Sand et al. Oct 2012 B2
8282644 Edwards Oct 2012 B2
8282645 Lawrence et al. Oct 2012 B2
8292966 Morton Oct 2012 B2
8303596 Plassky et al. Nov 2012 B2
8313492 Wong et al. Nov 2012 B2
8323289 Re Dec 2012 B2
8337503 Lian Dec 2012 B2
8343159 Bennett Jan 2013 B2
8377105 Bscher Feb 2013 B2
D679395 Wright et al. Apr 2013 S
8409209 Ammann et al. Apr 2013 B2
8435246 Fisher et al. May 2013 B2
8475462 Thomas et al. Jul 2013 B2
8496662 Novak et al. Jul 2013 B2
8518045 Szanto Aug 2013 B2
8523870 Green, II et al. Sep 2013 B2
8529571 Horan et al. Sep 2013 B2
8535317 Szanto Sep 2013 B2
8540777 Ammann et al. Sep 2013 B2
D694884 Mooradian et al. Dec 2013 S
D695402 Dacosta et al. Dec 2013 S
8652142 Geissler Feb 2014 B2
8657820 Kubiak et al. Feb 2014 B2
D701303 Cook Mar 2014 S
8672945 Lavallee et al. Mar 2014 B2
8696716 Kartalian et al. Apr 2014 B2
8702715 Ammann et al. Apr 2014 B2
D705929 Frey May 2014 S
8715363 Ratron et al. May 2014 B2
8728084 Berelsman et al. May 2014 B2
8758354 Habegger et al. Jun 2014 B2
8764760 Metzger et al. Jul 2014 B2
8764763 Wong et al. Jul 2014 B2
8771279 Philippon et al. Jul 2014 B2
8777948 Bernsteiner Jul 2014 B2
8784427 Fallin et al. Jul 2014 B2
8784457 Graham Jul 2014 B2
8795286 Sand et al. Aug 2014 B2
8801727 Chan et al. Aug 2014 B2
8808303 Stemniski et al. Aug 2014 B2
8828012 May et al. Sep 2014 B2
8858602 Weiner et al. Oct 2014 B2
8882778 Ranft Nov 2014 B2
8882816 Kartalian et al. Nov 2014 B2
8888785 Ammann et al. Nov 2014 B2
D720456 Dacosta et al. Dec 2014 S
8900247 Tseng et al. Dec 2014 B2
8906026 Ammann et al. Dec 2014 B2
8915922 Fitzpatrick et al. Dec 2014 B2
8945132 Plassky et al. Feb 2015 B2
8998903 Price et al. Apr 2015 B2
8998904 Zeetser et al. Apr 2015 B2
D730132 Szanto May 2015 S
9023052 Lietz et al. May 2015 B2
9044250 Olsen et al. Jun 2015 B2
9060822 Lewis et al. Jun 2015 B2
9089376 Medoff et al. Jul 2015 B2
9101421 Blacklidge Aug 2015 B2
9107715 Blitz et al. Aug 2015 B2
9113920 Ammann et al. Aug 2015 B2
D740424 Dacosta et al. Oct 2015 S
9427240 Von Zabern et al. Aug 2016 B2
D765844 DaCosta Sep 2016 S
D766434 DaCosta Sep 2016 S
D766437 DaCosta Sep 2016 S
D766438 DaCosta Sep 2016 S
D766439 DaCosta Sep 2016 S
9452057 Dacosta et al. Sep 2016 B2
9750538 Soffiatti et al. Sep 2017 B2
9750551 Nichols Sep 2017 B1
9785747 Geebelen Oct 2017 B2
9980760 Dacosta et al. May 2018 B2
10028750 Rose Jul 2018 B2
10064631 Dacosta et al. Sep 2018 B2
10159499 Dacosta et al. Dec 2018 B2
10292713 Fallin et al. May 2019 B2
10327829 Dacosta et al. Jun 2019 B2
10376268 Fallin et al. Aug 2019 B2
11304705 Fallin et al. Apr 2022 B2
20020099381 Maroney Jul 2002 A1
20020107519 Dixon et al. Aug 2002 A1
20020165552 Duffner Nov 2002 A1
20020198531 Millard et al. Dec 2002 A1
20040010259 Keller et al. Jan 2004 A1
20040039394 Conti et al. Feb 2004 A1
20040065117 Chen et al. Apr 2004 A1
20040097946 Dietzel et al. May 2004 A1
20040138669 Horn Jul 2004 A1
20050004676 Schon et al. Jan 2005 A1
20050059978 Sherry et al. Mar 2005 A1
20050070909 Egger et al. Mar 2005 A1
20050075641 Singhatat et al. Apr 2005 A1
20050101961 Huebner et al. May 2005 A1
20050149042 Metzger Jul 2005 A1
20050228389 Stiernborg Oct 2005 A1
20050251147 Novak Nov 2005 A1
20050267482 Hyde, Jr. Dec 2005 A1
20050273112 McNamara Dec 2005 A1
20060015102 Toullec et al. Jan 2006 A1
20060129163 McGuire Jun 2006 A1
20060206044 Simon Sep 2006 A1
20060217733 Plassky et al. Sep 2006 A1
20060229621 Cadmus Oct 2006 A1
20060241607 Myerson et al. Oct 2006 A1
20060241608 Myerson et al. Oct 2006 A1
20060264961 Murray-Brown Nov 2006 A1
20070010818 Stone et al. Jan 2007 A1
20070123857 Deffenbaugh et al. May 2007 A1
20070233138 Figueroa et al. Oct 2007 A1
20070265634 Weinstein Nov 2007 A1
20070276383 Rayhack Nov 2007 A1
20080009863 Bond et al. Jan 2008 A1
20080039850 Rowley et al. Feb 2008 A1
20080091197 Coughlin Apr 2008 A1
20080140081 Heavener et al. Jun 2008 A1
20080147073 Ammann et al. Jun 2008 A1
20080172054 Claypool et al. Jul 2008 A1
20080195215 Morton Aug 2008 A1
20080208252 Holmes Aug 2008 A1
20080262500 Collazo Oct 2008 A1
20080269908 Warburton Oct 2008 A1
20090036893 Kartalian et al. Feb 2009 A1
20090036931 Pech et al. Feb 2009 A1
20090054899 Ammann et al. Feb 2009 A1
20090093849 Grabowski Apr 2009 A1
20090105767 Reiley Apr 2009 A1
20090118733 Orsak et al. May 2009 A1
20090198244 Leibel Aug 2009 A1
20090198279 Zhang et al. Aug 2009 A1
20090222047 Graham Sep 2009 A1
20090254092 Albiol Llorach Oct 2009 A1
20090254126 Orbay et al. Oct 2009 A1
20090287309 Walch et al. Nov 2009 A1
20100069910 Hasselman Mar 2010 A1
20100121334 Couture et al. May 2010 A1
20100130981 Richards May 2010 A1
20100152782 Stone et al. Jun 2010 A1
20100168799 Schumer Jul 2010 A1
20100185245 Paul et al. Jul 2010 A1
20100249779 Hotchkiss et al. Sep 2010 A1
20100256687 Neufeld et al. Oct 2010 A1
20100274293 Terrill et al. Oct 2010 A1
20100318088 Warne et al. Dec 2010 A1
20100324556 Tyber et al. Dec 2010 A1
20110093084 Morton Apr 2011 A1
20110245835 Dodds et al. Oct 2011 A1
20110264149 Pappalardo Oct 2011 A1
20110288550 Orbay et al. Nov 2011 A1
20110301648 Lofthouse et al. Dec 2011 A1
20120016426 Robinson Jan 2012 A1
20120065689 Prasad et al. Mar 2012 A1
20120078258 Lo et al. Mar 2012 A1
20120123420 Honiball May 2012 A1
20120123484 Lietz et al. May 2012 A1
20120130376 Loring et al. May 2012 A1
20120130383 Budoff May 2012 A1
20120184961 Johannaber Jul 2012 A1
20120185056 Warburton Jul 2012 A1
20120191199 Raemisch Jul 2012 A1
20120239045 Li Sep 2012 A1
20120253350 Anthony et al. Oct 2012 A1
20120265301 Demers et al. Oct 2012 A1
20120277745 Lizee et al. Nov 2012 A1
20120303033 Weiner et al. Nov 2012 A1
20120330135 Millahn et al. Dec 2012 A1
20130012949 Fallin et al. Jan 2013 A1
20130035694 Grimm et al. Feb 2013 A1
20130085499 Lian Apr 2013 A1
20130096563 Meade et al. Apr 2013 A1
20130131821 Cachia May 2013 A1
20130150900 Haddad et al. Jun 2013 A1
20130150903 Vincent Jun 2013 A1
20130158556 Jones et al. Jun 2013 A1
20130165936 Myers Jun 2013 A1
20130165938 Chow et al. Jun 2013 A1
20130172942 Lewis et al. Jul 2013 A1
20130184714 Kaneyama et al. Jul 2013 A1
20130190765 Harris et al. Jul 2013 A1
20130190766 Harris et al. Jul 2013 A1
20130204259 Zajac Aug 2013 A1
20130226248 Hatch et al. Aug 2013 A1
20130226252 Mayer Aug 2013 A1
20130231668 Olsen et al. Sep 2013 A1
20130237987 Graham Sep 2013 A1
20130237989 Bonutti Sep 2013 A1
20130267956 Terrill et al. Oct 2013 A1
20130310836 Raub et al. Nov 2013 A1
20130325019 Thomas et al. Dec 2013 A1
20130325076 Palmer et al. Dec 2013 A1
20130331845 Horan et al. Dec 2013 A1
20130338785 Wong Dec 2013 A1
20140005672 Edwards et al. Jan 2014 A1
20140025127 Richter Jan 2014 A1
20140039501 Schickendantz et al. Feb 2014 A1
20140039561 Weiner et al. Feb 2014 A1
20140046387 Waizenegger Feb 2014 A1
20140074099 Vigneron et al. Mar 2014 A1
20140074101 Collazo Mar 2014 A1
20140094861 Fallin Apr 2014 A1
20140094924 Hacking et al. Apr 2014 A1
20140135775 Maxson et al. May 2014 A1
20140163563 Reynolds et al. Jun 2014 A1
20140171953 Gonzalvez et al. Jun 2014 A1
20140180342 Lowery et al. Jun 2014 A1
20140188139 Fallin et al. Jul 2014 A1
20140194884 Martin et al. Jul 2014 A1
20140194999 Orbay et al. Jul 2014 A1
20140207144 Lee et al. Jul 2014 A1
20140249537 Wong et al. Sep 2014 A1
20140257308 Johannaber Sep 2014 A1
20140257509 Dacosta et al. Sep 2014 A1
20140276815 Riccione Sep 2014 A1
20140276853 Long et al. Sep 2014 A1
20140277176 Buchanan et al. Sep 2014 A1
20140277214 Helenbolt et al. Sep 2014 A1
20140288562 Von Zabern et al. Sep 2014 A1
20140296995 Reiley et al. Oct 2014 A1
20140303621 Gerold et al. Oct 2014 A1
20140336658 Luna et al. Nov 2014 A1
20140343555 Russi et al. Nov 2014 A1
20140350561 Dacosta et al. Nov 2014 A1
20150032168 Orsak et al. Jan 2015 A1
20150045801 Axelson, Jr. et al. Feb 2015 A1
20150045839 Dacosta et al. Feb 2015 A1
20150051650 Verstreken et al. Feb 2015 A1
20150057667 Ammann et al. Feb 2015 A1
20150066094 Prandi et al. Mar 2015 A1
20150112446 Melamed et al. Apr 2015 A1
20150119944 Geldwert Apr 2015 A1
20150142064 Perez et al. May 2015 A1
20150150608 Sammarco Jun 2015 A1
20150182273 Stemniski et al. Jul 2015 A1
20150223851 Hill et al. Aug 2015 A1
20150245858 Weiner et al. Sep 2015 A1
20160015426 Dayton et al. Jan 2016 A1
20160022315 Soffiatti et al. Jan 2016 A1
20160135858 Dacosta et al. May 2016 A1
20160151165 Fallin et al. Jun 2016 A1
20160175089 Fallin et al. Jun 2016 A1
20160192950 Dayton et al. Jul 2016 A1
20160192970 Dayton et al. Jul 2016 A1
20160199076 Fallin et al. Jul 2016 A1
20160213384 Fallin et al. Jul 2016 A1
20160235414 Hatch et al. Aug 2016 A1
20160242791 Fallin Aug 2016 A1
20160256204 Patel et al. Sep 2016 A1
20160324532 Montoya et al. Nov 2016 A1
20160354127 Lundquist et al. Dec 2016 A1
20170014173 Smith et al. Jan 2017 A1
20170042598 Santrock et al. Feb 2017 A1
20170042599 Bays et al. Feb 2017 A1
20170056031 Awtrey Mar 2017 A1
20170079669 Bays et al. Mar 2017 A1
20170143511 Cachia May 2017 A1
20170164989 Weiner et al. Jun 2017 A1
20180110530 Wagner et al. Apr 2018 A1
20180132868 Dacosta et al. May 2018 A1
20180344334 Kim et al. Dec 2018 A1
Foreign Referenced Citations (99)
Number Date Country
2009227957 Jul 2014 AU
2491824 Sep 2005 CA
2854997 May 2013 CA
695846 Sep 2006 CH
1457968 Nov 2003 CN
2930668 Aug 2007 CN
201558162 Aug 2010 CN
201572172 Sep 2010 CN
201586060 Sep 2010 CN
201912210 Aug 2011 CN
101237835 Nov 2012 CN
202801773 Mar 2013 CN
103462675 Dec 2013 CN
103505276 Jan 2014 CN
203458450 Mar 2014 CN
102860860 May 2014 CN
203576647 May 2014 CN
104490460 Apr 2015 CN
104510523 Apr 2015 CN
104523327 Apr 2015 CN
104546102 Apr 2015 CN
204379413 Jun 2015 CN
204410951 Jun 2015 CN
204428143 Jul 2015 CN
204428144 Jul 2015 CN
204428145 Jul 2015 CN
204446081 Jul 2015 CN
2255312 May 1974 DE
4425456 Mar 1996 DE
202006010241 Mar 2007 DE
102007053058 Apr 2009 DE
685206 Sep 2000 EP
1508316 May 2007 EP
1897509 Jul 2009 EP
2124772 Dec 2009 EP
2124832 Aug 2012 EP
2632349 Sep 2013 EP
2665428 Nov 2013 EP
2742878 Jun 2014 EP
2750617 Jul 2014 EP
2849684 Mar 2015 EP
2624764 Dec 2015 EP
3023068 May 2016 EP
2304322 Oct 1976 FR
2362616 Mar 1978 FR
2764183 Nov 1999 FR
2953120 Jan 2012 FR
3030221 Jun 2016 FR
2154143 Sep 1985 GB
2154144 Sep 1985 GB
2334214 Jan 2003 GB
200903719 Jun 2009 IN
200904479 May 2010 IN
140DELNP2012 Feb 2013 IN
2004KOLNP2013 Nov 2013 IN
4134243 Aug 2008 JP
4162380 Oct 2008 JP
2011092405 May 2011 JP
2011523889 Aug 2011 JP
4796943 Oct 2011 JP
5466647 Apr 2014 JP
2014511207 May 2014 JP
2014521384 Aug 2014 JP
5628875 Nov 2014 JP
100904142 Jun 2009 KR
756 Nov 2014 MD
2074810 Mar 1997 RU
2098036 Dec 1997 RU
2195892 Jan 2003 RU
2320287 Mar 2008 RU
2321366 Apr 2008 RU
2321369 Apr 2008 RU
2346663 Feb 2009 RU
2412662 Feb 2011 RU
1333328 Aug 1987 SU
0166022 Sep 2001 WO
03075775 Sep 2003 WO
2004089227 Oct 2004 WO
2008051064 May 2008 WO
2009029798 Mar 2009 WO
2009032101 Mar 2009 WO
2011037885 Mar 2011 WO
2012029008 Mar 2012 WO
2013090392 Jun 2013 WO
2013134387 Sep 2013 WO
2013169475 Nov 2013 WO
2014020561 Feb 2014 WO
2014022055 Feb 2014 WO
2014035991 Mar 2014 WO
2014085882 Jun 2014 WO
2014147099 Sep 2014 WO
2014152219 Sep 2014 WO
2014152535 Sep 2014 WO
2014177783 Nov 2014 WO
2014200017 Dec 2014 WO
2015094409 Jun 2015 WO
2015105880 Jul 2015 WO
2015127515 Sep 2015 WO
2016134160 Aug 2016 WO
Non-Patent Literature Citations (171)
Entry
Dayton et al., “Dorsal Suspension Stitch: An Alternative Stabilization After Flexor Tenotomy for Flexible Hammer Digit Syndrome,” The Journal of Foot and Ankle Surgery, vol. 48, No. 5, Sep./Oct. 2009, pp. 602-605.
Dayton et al., “The Extended Knee Hemilithotomy Position for Gastrocnemius Recession,” The Journal of Foot and Ankle Surgery, vol. 49, 2010, pp. 214-216.
Wienke et al., “Bone Stimulation for Nonunions: What the Evidence Reveals,” Podiatry Today, vol. 24, No. 9, Sep. 2011, pp. 52-57.
Dayton et al., “Hallux Varus as Complication of Foot Compartment Syndrome,” The Journal of Foot and Ankle Surgery, vol. 50, 2011, pp. 504-506.
Dayton et al., “Measurement of Mid-Calcaneal Length on Plain Radiographs: Reliability of a New Method,” Foot and Ankle Specialist, vol. 4, No. 5, Oct. 2011, pp. 280-283.
Dayton et al., “A User-Friendly Method of Pin Site Management for External Fixators,” Foot and Ankle Specialist, Sep. 16, 2011, 4 pages.
Dayton et al., “Effectiveness of a Locking Plate in Preserving Midcalcaneal Length and Positional Outcome after Evans Calcaneal Osteotomy: A Retrospective Pilot Study,” The Journal of Foot and Ankle Surgery, vol. 52, 2013, pp. 710-713.
Dayton et al., “Does Postoperative Showering or Bathing of a Surgical Site Increase the Incidence of Infection? A Systematic Review of the Literature,” The Journal of Foot and Ankle Surgery, vol. 52, 2013, pp. 612-614.
Dayton et al., “Technique for Minimally Invasive Reduction of Calcaneal Fractures Using Small Bilateral External Fixation,” The Journal of Foot and Ankle Surgery, Article in Press, 2014, 7 pages.
Dayton et al., “Clarification of the Anatomic Definition of the Bunion Deformity,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 160-163.
Dayton et al., “Observed Changes in Radiographic Measurements of the First Ray after Frontal Plane Rotation of the First Metatarsal in a Cadaveric Foot Model,” The Journal of Foot and Ankle Surgery, Article in Press, 2014, 5 pages.
Dayton et al., “Observed Changes in First Metatarsal and Medial Cuneiform Positions after First Metatarsophalangeal Joint Arthrodesis,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 32-35.
Dayton et al., “Reduction of the Intermetatarsal Angle after First Metatarsal Phalangeal Joint Arthrodesis: A Systematic Review,” The Journal of Foot and Ankle Surgery, Article in Press, 2014, 4 pages.
Feilmeier et al., “Reduction of Intermetatarsal Angle after First Metatarsophalangeal Joint Arthrodesis in Patients with Hallux Valgus,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 29-31.
Dayton et al., “Principles of Management of Growth Plate Fractures in the Foot and Ankle,” Clinics in Podiatric Medicine and Surgery, Pediatric Foot Deformities, Oct. 2013, 17 pages.
Dayton et al., “Observed Changes in Radiographic Measurements of the First Ray after Frontal and Transverse Plane Rotation of the Hallux: Does the Hallux Drive the Metatarsal in a Bunion Deformity?,” The Journal of Foot and Ankle Surgery, Article in Press, 2014, 4 pages.
Rodriguez et al., “Ilizarov method of fixation for the management of pilon and distal tibial fractures in the compromised diabetic patient: A technique guide,” The Foot and Ankle Journal Online, vol. 7, No. 2, 2014, 9 pages.
Feilmeier et al., “Incidence of Surgical Site Infection in the Foot and Ankle with Early Exposure and Showering of Surgical Sites: A Prospective Observation,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 173-175.
Catanese et al., “Measuring Sesamoid Position in Hallux Valgus: When Is the Sesamoid Axial View Necessary,” Foot and Ankle Specialist, 2014, 3 pages.
Dayton et al., “Comparison of Complications for Internal and External Fixation for Charcot Reconstruction: A Systematic Review,” The Journal of Foot and Ankle Surgery, Article in Press, 2015, 4 pages.
Dayton et al., “A new triplanar paradigm for bunion management,” Lower Extremity Review, Apr. 2015, 9 pages.
Dayton et al., “American College of Foot and Ankle Surgeons' Clinical Consensus Statement: Perioperative Prophylactic Antibiotic Use in Clean Elective Foot Surgery,” The Journal of Foot and Ankle Surgery, Article in Press, 2015, 7 pages.
Dayton et al., “Complications of Metatarsal Suture Techniques for Bunion Correction: A Systematic Review of the Literature,” The Journal of Foot and Ankle Surgery, Article in Press, 2015, 3 pages.
DeCarbo et al., “The Weil Osteotomy: A Refresher,” Techniques in Foot and Ankle Surgery, vol. 13, No. 4, Dec. 2014, pp. 191-198.
DeCarbo et al., “Resurfacing Interpositional Arthroplasty for Degenerative Joint Diseas of the First Metatarsalphalangeal Joint,” Podiatry Management, Jan. 2013, pp. 137-142.
DeCarbo et al., “Locking Plates: Do They Prevent Complications?,” Podiatry Today, Apr. 2014, 7 pages.
Easley et al., “Current Concepts Review: Hallux Valgus Part II: Operative Treatment,” Foot and Ankle International, vol. 28, No. 6, Jun. 2007, pp. 748-758.
Kim et lal., “A Multicenter Retrospective Review of Outcomes for Arthrodesis, Hemi-Metallic Joint Implant, and Resectional Arthroplasty in the Surgical Treatment of End-Stage Hallux Rigidus,” The Journal of Foot and Ankle Surgery, vol. 51, 2012, pp. 50-56.
Easley et al., “Current Concepts Review: Hallux Valgus Part I: Pathomechanics, Clinical Assessment, and Nonoperative Management,” Foot and Ankle International, vol. 28, No. 5, May 2007, pp. 654-659.
Sandhu et al., “Digital Arthrodesis With a One-Piece Memory Nitinol Intramedullary Fixation Device: A Retrospective Review,” Foot and Ankle Specialist, vol. 6, No. 5, Oct. 2013, pp. 364-366.
Weber et al., “Use of the First Ray Splay Test to Assess Transverse Plane Instability Before First Metatarsocuneiform Fusion,” The Journal of Foot and Ankle Surgery, vol. 45, No. 4, Jul./Aug. 2006, pp. 278-282.
Smith et al., “Opening Wedge Osteotomies for Correction of Hallux Valgus: A Review of Wedge Plate Fixation,” Foot and Ankle Specialist, vol. 2, No. 6, Dec. 2009, pp. 277-282.
Easley et al., “What is the Best Treatment for Hallux Valgus?,” Evidence-Based Orthopaedics—The Best Answers to Clinical Questions, Chapter 73, 2009, pp. 479-491.
Shurnas et al., “Proximal Metatarsal Opening Wedge Osteotomy,” Operative Techniques in Foot and Ankle Surgery, Section I, Chapter 13, 2011, pp. 73-78.
Coetzee et al., “Revision Hallux Valgus Correction,” Operative Techniques in Foot and Ankle Surgery, Section I, Chapter 15, 2011, pp. 84-96.
Le et al., “Tarsometatarsal Arthrodesis,” Operative Techniques in Foot and Ankle Surgery, Section II, Chapter 40, 2011, pp. 281-285.
Collan et al., “The biomechanics of the first metatarsal bone in hallux valgus: A preliminary study utilizing a weight bearing extremity CT,” Foot and Ankle Surgery, vol. 19, 2013, pp. 155-161.
Eustace et al., “Hallux valgus, first metatarsal pronation and collapse of the medial longitudinal arch—a radiological correlation,” Skeletal Radiology, vol. 23, 1994, pp. 191-194.
Mizuno et al., “Detorsion Osteotomy of the First Metatarsal Bone in Hallux Valgus,” Japanese Orthopaedic Association, Tokyo, 1956; 30:813-819.
Okuda et al., “The Shape of the Lateral Edge of the First Metatarsal Head as a Risk Factor for Recurrence of Hallux Valgus,” The Journal of Bone and Joint Surgery, vol. 89, 2007, pp. 2163-2172.
Okuda et al., “Proximal Metatarsal Osteotomy for Hallux Valgus: Comparison of Outcome for Moderate and Severe Deformities,” Foot and Ankle International, vol. 29, No. 7, Jul. 2008, pp. 664-670.
D'Amico et al., “Motion of the First Ray: Clarification Through Investigation,” Journal of the American Podiatry Association, vol. 69, No. 1, Jan. 1979, pp. 17-23.
Groves, “Operative Report,” St. Tammany Parish Hospital, Date of Procedure, Mar. 26, 2014, 2 pages.
Claim Chart for Groves Public Use (Mar. 26, 2014), Exhibit B4 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 161 pages.
“Accu-Cut Osteotomy Guide System,” BioPro, Brochure, Oct. 2018, 2 pages.
“Acumed Osteotomiesystem Operationstechnik,” Acumed, 2014, 19 pages (including 3 pages English translation).
Blomer, “Knieendoprothetik—Herstellerische Probleme und technologische Entwicklungen,” Orthopade, vol. 29, 2000, pp. 688-696, including English Abstract on p. 689.
Bouaicha et al., “Fixation of Maximal Shift Scarf Osteotomy with Inside-Out Plating: Technique Tip,” Foot & Ankle International, vol. 32, No. 5, May 2011, pp. 567-569.
“Futura Forefoot Implant Arthroplasty Products,” Tornier, Inc., 2008, 14 pages.
Gotte, “Entwicklung eines Assistenzrobotersystems für die Knieendoprothetik,” Forschungsberichte, Technische Universitat Munchen, 165, 2002, 11 pages, including partial English Translation.
Gregg et al., “Plantar plate repair and Weil osteotomy for metatarsophalangeal joint instability,” Foot and Ankle Surgery, vol. 13, 2007, pp. 116-121.
“Hat-Trick Lesser Toe Repair System, Foot and Ankle Technique Guide, Metatarsal Shortening Osteotomy Surgical Technique,” Smith & Nephew, 2014, 16 pages.
Hetherington et al., “Evaluation of surgical experience and the use of an osteotomy guide on the apical angle of an Austin osteotomy,” The Foot, vol. 18, 2008, pp. 159-164.
Hirao et al., “Computer assisted planning and custom-made surgical guide for malunited pronation deformity after first metatarsophalangeal joint arthrodesis in rheumatoid arthritis: A case report,” Computer Aided Surgery, vol. 19, Nos. 1-3, 2014, pp. 13-19.
Lieske et al., “Implantation einer Sprunggelenktotalendo-prothese vom Typ Salto 2,” Operative Orthopädie und Traumatologie, vol. 26, No. 4, 2014, pp. 401-413, including English Abstract on p. 403.
Magin, “Computernavigierter Gelenkersatz am Knie mit dem Orthopilot,” Operative Orthopädie und Traumatologie, vol. 22, No. 1, 2010, pp. 63-80, including English Abstract on p. 64.
Magin, “Die belastungsstabile Lapidus-Arthrodese bei Hallux-valgus-Deformität mittels IVP-Plattenfixateur (V-TEK-System),” Operative Orthopädie und Traumatologie, vol. 26, No. 2, 2014, pp. 184-195, including English Abstract on p. 186.
Miyake et al., “Three-Dimensional Corrective Osteotomy for Malunited Diaphyseal Forearm Fractures Using Custom-Made Surgical Guides Based on Computer Simulation,” JBJS Essential Surgical Techniques, vol. 2, No. 4, 2012, 11 pages.
Nagy et al., “The AO Ulnar Shortening Osteotomy System Indications and Surgical Technique,” Journal of Wrist Surgery, vol. 3, No. 2, 2014, pp. 91-97.
NexFix from Nexa Orthopedics, MetaFix I from Merete Medical, Inc. and The BioPro Lower Extremities from BioPro, found in Foot & Ankle International Journal, vol. 28, No. 1, Jan. 2007, 4 pages.
Odenbring et al., “A guide instrument for high tibial osteotomy,” Acta Orthopaedica Scandinavica, vol. 60, No. 4, 1989, pp. 449-451.
Otsuki et al., “Developing a novel custom cutting guide for curved per-acetabular osteotomy,” International Orthopaedics (SICOT), vol. 37, 2013, pp. 1033-1038.
“Patient to Patient Precision, Accu-Cut, Osteotomy Guide System,” BioPro, Foot & Ankle International Journal, vol. 23, No. 8, Aug. 2002, 2 pages.
Peters et al., “Flexor Hallucis Longus Tendon Laceration as a Complication of Total Ankle Arthroplasty,” Foot & Ankle International, vol. 34, No. 1, 2013, pp. 148-149.
“Prophecy Inbone Preoperative Navigation Guides,” Wright Medical Technology, Inc., Nov. 2013, 6 pages.
“Rayhack Ulnar Shortening Generation II Low-Profile Locking System Surgical Technique,” Wright Medical Technology, Inc., Dec. 2013, 20 pages.
Saltzman et al., “Prospective Controlled Trial of STAR Total Ankle Replacement Versus Ankle Fusion: Initial Results,” Foot & Ankle International, vol. 30, No. 7, Jul. 2009, pp. 579-596.
“Smith & Nephew scores a Hat-Trick with its entry into the high-growth hammer toe repair market,” Smith & Nephew, Jul. 31, 2014, 2 pages.
Tricot et al., “3D-corrective osteotomy using surgical guides for posttraumatic distal humeral deformity,” Acta Orthopaedica Belgica, vol. 78, No. 4, 2012, pp. 538-542.
Vitek et al., “Die Behandlung des Hallux rigidus mit Cheilektomie und Akin-Moberg-Osteotomie unter Verwendung einer neuen Schnittlehre und eines neuen Schraubensystems,” Orthopadische Praxis, vol. 44, Nov. 2008, pp. 563-566, including English Abstract on p. 564.
Vitek, “Neue Techniken in der Fußchirurgie Das V-tek-System,” ABW Wissenschaftsverlag GmbH, 2009, 11 pages, including English Abstract.
Weil et al., “Anatomic Plantar Plate Repair Using the Weil Metatarsal Osteotomy Approach,” Foot & Ankle Specialist, vol. 4, No. 3, 2011, pp. 145-150.
Wendl et al., “Navigation in der Knieendoprothetik,” OP-Journal, vol. 17, 2002, pp. 22-27, including English Abstract.
Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 41 pages.
Prior Art Publications, Exhibit A of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 3 pages.
Claim Chart for Fishco, “Making the Lapidus Easy,” The Podiatry Institute (Apr. 2014), Exhibit B1 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 97 pages.
Claim Chart for Fishco, “A Straightforward Guide to the Lapidus Bunionectomy,” HMP Global (Sep. 6, 2013), Exhibit B2 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 67 pages.
Claim Chart for Groves, “Functional Position Joint Sectioning: Pre-Load Method for Lapidus Arthrodesis,” Update 2015: Proceedings of the Annual Meeting of the Podiatry Institute, Chpt. 6, pp. 23-29 (Apr. 2015), Exhibit B3 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 151 pages.
Claim Chart for Mote, “First Metatarsal-Cuneiform Arthrodesis for the Treatment of First Ray Pathology: A Technical Guide,” The Journal Foot & Ankle Surgery (Sep. 1, 2009), Exhibit B5 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 21 pages.
Claim Chart for U.S. Pat. No. 10,376,268 to Fallin et al., entitled “Indexed Tri-Planar Osteotomy Guide and Method,” issued Aug. 13, 2019, Exhibit B6 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 155 pages.
Claim Chart for U.S. Pat. No. 8,282,645 to Lawrence et al., entitled “Metatarsal Bone Implant Cutting Guide,” issued Jan. 18, 2010, Exhibit B7 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 76 pages.
Claim Chart for U.S. Pat. No. 9,452,057 to Dacosta et al., entitled “Bone Implants and Cutting Apparatuses and Methods,” issued Apr. 8, 2011, Exhibit B8 of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 110 pages.
Obviousness Chart, Exhibit C of Defendant Fusion Orthopedics LLC's Invalidity Contentions, No. CV-22-00490-PHX-SRB, US District Court for the District of Arizona, Aug. 27, 2022, 153 pages.
“Foot and Ankle Instrument Set,” Smith & Nephew, 2013, 2 pages.
“Lapidus Pearls: Gaining Joint Exposure to Decrease Non-Union,” Youtube, Retrieved online from <https://www.youtube.com/watch?v=-jqJyE7pj-Y>, dated Nov. 2, 2009, 3 pages.
“Reconstructive Surgery of the Foot & Ankle,” The Podiatry Institute, Update 2015, Conference Program, May 2015, 28 pages.
“Speed Continuous Active Compression Implant,” BioMedical Enterprises, Inc., A120-029 Rev. 3, 2013, 4 pages.
“Visionaire: Patient Matched Cutting Blocks Surgical Procedure,” Smith & Nephew, Inc., 2009, 2 pages.
Arthrex, “Comprehensive Foot System,” Retrieved online from <https://www.arthrex.com/resources/animation/8U3iaPvY6kO8bwFAwZF50Q/comprehensive-foot-system?referringTeam=foot_and_ankle>, dated Aug. 27, 2013, 3 pages.
Baravarian, “Why the Lapidus Procedure is Ideal for Bunions,” Podiatry Today, Retrieved online from <https://www.hmpgloballearhmpgloballe.com/site/podipodi/article/5542>, dated May 2006, 8 pages.
Bauer et al., “Offset-V Osteotomy of the First Metatarsal Shaft in Hallux Abducto Valgus,” McGlamry's Comprehensive Textbook of Foot and Ankle Surgery, Fourth Edition, vol. 1, Chapter 29, 2013, 26 pages.
Cottom, “Fixation of the Lapidus Arthrodesis with a Plantar Interfragmentary Screw and Medial Low Profile Locking Plate,” The Journal of Foot & Ankle Surgery, vol. 51, 2012, pp. 517-522.
Coughlin, “Fixation of the Lapidus Arthrodesis with a Plantar Interfragmentary Screw and Medial Low Profile Locking Plate,” Orthopaedics and Traumatology, vol. 7, 1999, pp. 133-143.
Dayton et al., “Observed Changes in Radiographic Measurements of the First Ray after Frontal Plane Rotation of the First Metatarsal in a Cadaveric Foot Model,” The Journal of Foot & Ankle Surgery, vol. 53, 2014, pp. 274-278.
Dayton et al., “Relationship of Frontal Plane Rotation of First Metatarsal to Proximal Articular Set Angle and Hallux Alignment in Patients Undergoing Tarsometatarsal Arthrodesis for Hallux Abducto Valgus: A Case Series and Critical Review of the Literature,” The Journal of Foot & Ankle Surgery, 2013, Article in Press, Mar. 1, 2013, 7 pages.
DiDomenico et al., “Lapidus Bunionectomy: First Metatarsal-Cuneiform Arthrodesis,” McGlamry's Comprehensive Textbook of Foot and Ankle Surgery, Fourth Edition, vol. 1, Chapter 31, 2013, 24 pages.
Fallin et al., US Provisional Application Entitled Indexed Tri-Planar Osteotomy Guide and Method, U.S. Appl. No. 62/118,378, filed Feb. 19, 2015, 62 pages.
Fishco, “A Straightforward Guide to the Lapidus Bunionectomy,” Podiatry Today, Retrieved online from <https://www.hmpgloballearningnetwork.com/site/podiatry/blogged/straightforward-guide-lapidus-bunionectomy>, dated Sep. 6, 2013, 5 pages.
Fishco, “Making the Lapidus Easy,” The Podiatry Institute, Update 2014, Chapter 14, 2014, pp. 91-93.
Fleming et al., “Results of Modified Lapidus Arthrodesis Procedure Using Medial Eminence as an Interpositional Autograft,” The Journal of Foot & Ankle Surgery, vol. 50, 2011, pp. 272-275.
Fuhrmann, “Arthrodesis of the First Tarsometatarsal Joint for Correction of the Advanced Splayfoot Accompanied by a Hallux Valgus,” Operative Orthopadie und Traumatologie, No. 2, 2005, pp. 195-210.
Gerard et al., “The Modified Lapidus Procedure,” Orthopedics, vol. 31, No. 3, Mar. 2008, 7 pages.
Giannoudis et al., “Hallux Valgus Correction,” Practical Procedures in Elective Orthopaedic Surgery, Pelvis and Lower Extremity, Chapter 38, 2012, 22 pages.
Greiner, “The Jargon of Pedal Movements,” Foot & Ankle International, vol. 28, No. 1, Jan. 2007, pp. 109-125.
Groves, “Functional Position Joint Sectioning: Pre-Load Method for Lapidus Arthrodesis,” The Podiatry Institute, Update 2015, Chapter 6, 2015, pp. 23-29.
Hardy et al., “Observations on Hallux Valgus,” The Journal of Bone and Joint Surgery, vol. 33B, No. 3, Aug. 1951, pp. 376-391.
Holmes, Jr., “Correction of the Intermetatarsal Angle Component of Hallux Valgus Using Fiberwire-Attached Endo-buttons,” Revista Internacional de Ciencias Podologicas, vol. 6, No. 2, 2012, pp. 73-79.
Integra, “Integra Large Qwix Positioning and Fixation Screw, Surgical Technique,” 2012, 16 pages.
Kilmartin et al., “Combined rotation scarf and Akin osteotomies for hallux valgus: a patient focused 9 year follow up of 50 patients,” Journal of Foot and Ankle Research, vol. 3, No. 2, 2010, 12 pages.
Lee et al., “Technique Tip: Lateral Soft-Tissue Release for Correction of Hallux Valgus Through a Medial Incision Using a Dorsal Flap Over the First Metatarsal,” Foot & Ankle International, vol. 28, No. 8, Aug. 2007, pp. 949-951.
Mote et al., “First Metatarsal-Cuneiform Arthrodesis for the Treatment of First Ray Pathology: A Technical Guide,” JFAS Techniques Guide, vol. 48, No. 5, Sep./Oct. 2009, pp. 593-601.
Myerson, “Cuneiform-Metatarsal Arthrodesis,” The Foot and Ankle, Chapter 9, 1997, pp. 107-117.
Sammarco, “Surgical Strategies: Mau Osteotomy for Correction of Moderate and Severe Hallux Valgus Deformity,” Foot & Ankle International, vol. 28, No. 7, Jul. 2007, pp. 857-864.
Schon et al., “Cuneiform-Metatarsal Arthrodesis for Hallux Valgus,” The Foot and Ankle, Second Edition, Chapter 8, 2002, pp. 99-117.
Sokoloff, “Lapidus Procedure,” Textbook of Bunion Surgery, Chapter 15, 1981, pp. 277-287.
Stamatis et al., “Mini Locking Plate as “Medial Buttress” for Oblique Osteotomy for Hallux Valgus,” Foot & Ankle International, vol. 31, No. 10, Oct. 2010, pp. 920-922.
Stewart, “Use for BME Speed Nitinol Staple Fixation for the Lapidus Procedure,” date unknown, 1 page.
Wukich et al., “Hypermobility of the First Tarsometatarsal Joint,” Foot and Ankle Clinics, vol. 10, No. 1, Mar. 2005, pp. 157-166.
Dayton et al., “Biwinged Excision for Round Pedal Lesions,” The Journal of Foot and Ankle Surgery, vol. 35, No. 3, 1996, pp. 244-249.
Dayton et al., “Medial Incision Approach to the First Metatarsophalangeal Joint,” The Journal of Foot and Ankle Surgery, vol. 40, No. 6, Nov./Dec. 2001, pp. 414-417.
Dayton et al., “Reduction of the Intermetatarsal Angle after First Metatarsophalangeal Joint Arthrodesis in Patients with Moderate and Severe Metatarsus Primus Adductus,” The Journal of Foot and Ankle Surgery, vol. 41, No. 5, Sep./Oct. 2002, pp. 316-319.
Dayton et al., “Use of the Z Osteotomy for Tailor Bunionectomy,” The Journal of Foot and Ankle Surgery, vol. 42, No. 3, May/Jun. 2003, pp. 167-169.
Dayton et al., “Early Weightbearing After First Metatarsophalangeal Joint Arthrodesis: A Retrospective Observational Case Analysis,” The Journal of Foot and Ankle Surgery, vol. 43, No. 3, May/Jun. 2004, pp. 156-159.
Albano et al., “Biomechanical Study of Transcortical or Transtrabecular Bone Fixation of Patellar Tendon Graft wih Bioabsorbable Pins in ACL Reconstruction in Sheep,” Revista Brasileira de Ortopedia (Rev Bras Ortop.) vol. 47, No. 1, 2012, pp. 43-49.
Anderson et al., “Uncemented STAR Total Ankle Prostheses,” The Journal of Bone and Joint Surgery, vol. 86(1, Suppl 2), Sep. 2004, pp. 103-111, (Abstract Only).
Dayton et al., “Is Our Current Paradigm for Evaluation and Management of the Bunion Deformity Flawed? A Discussion of Procedure Philosophy Relative to Anatomy,” The Journal of Foot and Ankle Surgery, vol. 54, 2015, pp. 102-111.
Dayton et al., “Observed Changes in Radiographic Measurements of the First Ray after Frontal and Transverse Plane Rotation of the Hallux: Does the Hallux Drive the Metatarsal in a Bunion Deformity?,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 584-587.
Dayton et al., “Relationship of Frontal Plane Rotation of First Metatarsal to Proximal Articular Set Angle and Hallux Alignment in Patients Undergoing Tarsometatarsal Arthrodesis for Hallux Abducto Valgus: A Case Series and Critical Review of the Literature,” The Journal of Foot and Ankle Surgery, vol. 52, No. 3, May/Jun. 2013, pp. 348-354.
Dayton et al., “Quantitative Analysis of the Degree of Frontal Rotation Required to Anatomically Align the First Metatarsal Phalangeal Joint During Modified Tarsal-Metatarsal Arthrodesis Without Capsular Balancing,” The Journal of Foot and Ankle Surgery, 2015, pp. 1-6.
De Geer et al., “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans,” Foot and Ankle International, Mar. 26, 2015, 9 pages.
DiDomenico et al., “Correction of Frontal Plane Rotation of Sesamoid Apparatus during the Lapidus Procedure: A Novel Approach,” The Journal of Foot and Ankle Surgery, vol. 53, 2014, pp. 248-251.
Dobbe et al. “Patient-Tailored Plate for Bone Fixation and Accurate 3D Positioning in Corrective Osteotomy,” Medical and Biological Engineering and Computing, vol. 51, No. 1-2, Feb. 2013, pp. 19-27, (Abstract Only).
EBI Extra Small Rail Fixator, Biomet Trauma, retrieved Dec. 19, 2014, from the Internet: <http://footandanklefixation.com/product/biomet-trauma-ebi-extra-small-rail-fixator>, 7 pages.
Garthwait, “Accu-Cut System Facilitates Enhanced Precision,” Podiatry Today, vol. 18, No. 6, Jun. 2005, 6 pages.
Gonzalez Del Pino et al., “Variable Angle Locking Intercarpal Fusion System for Four-Corner Arthrodesis: Indications and Surgical Technique,” Journal of Wrist Surgery, vol. 1, No. 1, Aug. 2012, pp. 73-78.
Grondal et al., “A Guide Plate for Accurate Positioning of First Metatarsophalangeal Joint during Fusion,” Operative Orthopädie Und Traumatologie, vol. 16, No. 2, 2004, pp. 167-178 (Abstract Only).
“Hat-Trick Lesser Toe Repair System,” Smith & Nephew, Brochure, Aug. 2014, 12 pages.
“Hoffmann II Compact External Fixation System,” Stryker, Brochure, Literature No. 5075-1-500, 2006, 12 pages.
“Hoffmann II Micro Lengthener,” Stryker, Operative Technique, Literature No. 5075-2-002, 2008, 12 pages.
“Hoffmann Small System External Fixator Orthopedic Instruments,” Stryker, retrieved Dec. 19, 2014, from the Internet: <http://www.alibaba.com/product-detail/Stryker-Hoffmann-Small-System-External-Fixator_1438850129.html>, 3 pages.
Kim et al., “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans,” Foot and Ankle International, vol. 36, No. 8, 2015, pp. 944-952.
“Lag Screw Target Bow,” Stryker Leibinger GmbH & Co. KG, Germany 2004, 8 pages.
MAC (Multi Axial Correction) Fixation System, Biomet Trauma, retrieved Dec. 19, 2014, from the Internet: <http://footandanklefixation.com/product/biomet-trauma-mac-multi-axial-correction-fixation-system>, 7 pages.
Michelangelo Bunion System, Surgical Technique, Instratek Incorporated, publication date unknown, 4 pages.
Mini Joint Distractor, Arthrex, retrieved Dec. 19, 2014, from the Internet: <http://www.arthrex.com/foot-ankle/mini-joint-distractor/products>, 2 pages.
MiniRail System, Small Bone Innovations, Surgical Technique, 2010, 24 pages.
Modular Rail System: External Fixator, Smith & Nephew, Surgical Technique, 2013, 44 pages.
Monnich et al., “A Hand Guided Robotic Planning System for Laser Osteotomy in Surgery,” World Congress on Medical Physics and Biomedical Engineering vol. 25/6: Surgery, Nimimal Invasive Interventions, Endoscopy and Image Guided Therapy, Sep. 7-12, 2009, pp. 59-62, (Abstract Only).
Moore et al., “Effect of Ankle Flexion Angle on Axial Alignment of Total Ankle Replacement,” Foot and Ankle International, vol. 31, No. 12, Dec. 2010, pp. 1093-1098, (Abstract Only).
Mortier et al., “Axial Rotation of the First Metatarsal Head in a Normal Population and Hallux Valgus Patients,” Orthopaedics and Traumatology: Surgery and Research, vol. 98, 2012, pp. 677-683.
Okuda et al., “Postoperative Incomplete Reduction of the Sesamoids as a Risk Factor for Recurrence of Hallux Valgus,” The Journal of Bone and Joint Surgery, vol. 91-A, No. 1, Jul. 2009, pp. 1637-1645.
Rx-Fix Mini Rail External Fixator, Wright Medical Technology, Brochure, Aug. 15, 2014, 2 pages.
Scanlan et al. “Technique Tip: Subtalar Joint Fusion Using a Parallel Guide and Double Screw Fixation,” The Journal of Foot and Ankle Surgery, vol. 49, Issue 3, May-Jun. 2010, pp. 305-309, (Abstract Only).
Scranton Jr. et al, “Anatomic Variations in the First Ray: Part I. Anatomic Aspects Related to Bunion Surgery,” Clinical Orthopaedics and Related Research, vol. 151, Sep. 1980, pp. 244-255.
Siddiqui et al. “Fixation of Metatarsal Fracture With Bone Plate in a Dromedary Heifer,” Open Veterinary Journal, vol. 3, No. 1, 2013, pp. 17-20.
Sidekick Stealth Rearfoot Fixator, Wright Medical Technology, Surgical Technique, Dec. 2, 2013, 20 pages.
Simpson et al., “Computer-Assisted Distraction Ostegogenesis by Ilizarov's Method,” International Journal of Medical Robots and Computer Assisted Surgery, vol. 4, No. 4, Dec. 2008, pp. 310-320, (Abstract Only).
Small Bone External Fixation System, Acumed, Surgical Technique, Effective date Sep. 2014, 8 pages.
Stableloc External Fixation System, Acumed, Product Overview, Effective date Sep. 2015, 4 pages.
Stahl et al., “Derotation of Post-Traumatic Femoral Deformities by Closed Intramedullary Sawing,” Injury, vol. 37, No. 2, Feb. 2006, pp. 145-151, (Abstract Only).
Talbot et al.,“Assessing Sesamoid Subluxation: How Good is the AP Radiograph?,” Foot and Ankle International, vol. 19, No. 8, Aug. 1998, pp. 547-554.
TempFix Spanning the Ankle Joint Half Pin and Transfixing Pin Techniques, Biomet Orthopedics, Surgical Technique, 2012, 16 pages.
Weber et al., “A Simple System for Navigation of Bone Alignment Osteotomies of the Tibia,” International Congress Series, vol. 1268, Jan. 2004, pp. 608-613, (Abstract Only).
Whipple et al., “Zimmer Herbert Whipple Bone Screw System: Surgical Techniques for Fixation of Scaphoid and Other Small Bone Fractures,” Zimmer, 2003, 59 pages.
Yakacki et al. “Compression Forces of Internal and External Ankle Fixation Devices with Simulated Bone Resorption,” Foot and Ankle International, vol. 31, No. 1, Jan. 2010, pp. 76-85, (Abstract Only).
Yasuda et al., “Proximal Supination Osteotomy of the First Metatarsal for Hallux Valgus,” Foot and Ankle International, vol. 36, No. 6, Jun. 2015, pp. 696-704.
Dayton et al.“Evidence-Based Bunion Surgery: A Critical Examination of Current and Emerging Concepts and Techniques,” Springer International Publishing, 2017, 254 pages.
Joung et al., “A spherical bone cutting system for Rotational Acetabular Osteotomy,” World Congress on Medical Physics and Biomedical Engineering, 2006, pp. 3130-3133 (Abstract Only).
Koyama et al., “Computer-assisted spherical osteotomy with a curved-bladed Tuke Saw®,” Computer Aided Surgery, vol. 11, No. 4, Jul. 2006, pp. 202-208.
Sakuma et al., “A bone cutting device for rotational acetabular osteotomy (RAO) with a curved oscillating saw,” International Congress Series, vol. 1268, 2004, pp. 632-637.
Weil Foot & Ankle Institute, “Scarf Akin Procedure for Bunion Correction,” YouTube video, published on Jul. 29, 2008 to https://www.youtube.com/watch?v=Sh2V8QvbaGc, 4 pages of example screen shots.
Related Publications (1)
Number Date Country
20210361294 A1 Nov 2021 US
Provisional Applications (1)
Number Date Country
62380074 Aug 2016 US
Continuations (1)
Number Date Country
Parent 15687994 Aug 2017 US
Child 17392010 US