Key Fragment Guide and Related Methods

Abstract

The primary fragment guide is configured to be temporarily secured to a primary fragment of a metatarsal bone surgically separated from a proximal portion of the metatarsal bone. The primary fragment guide can be manipulated to correspondingly manipulate the primary fragment, thereby correcting the bunion. The implant can permanently secure the proximal portion to the primary fragment.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This claims the priority of U.S. Patent Application No. 63 / 186,720, filed on May 10, 2021, the disclosure of which is incorporated herein by reference in its entirety as if fully set forth herein.

[0002] (Field of the Invention) The present disclosure relates to surgical instruments and methods for treating foot deformities by minimally invasive bunion correction.

Background Art

[0003] A bunion is typically a progressive disorder that begins with the inclination of the big toe, gradually changes the angle of the bone, and may cause a characteristic bump on the inner side of the metatarsal bone near the joint between the metatarsal bone and the proximal phalanx. Specifically, a bunion is a bony prominence and sometimes an inflammatory bursa. Hallux valgus is a condition where the big toe is displaced from its normal position in the direction of the second toe.

[0004] Correction or repair of bunions is a common surgery, with 100,000 surgeries performed annually in the United States. Many surgical procedures for bunion repair are invasive, painful, require an incision of several inches, and a long recovery period of up to 10 - 12 weeks. Minimally invasive surgery has been carried out in orthopedic surgery for decades.

Summary of the Invention

Problems to be Solved by the Invention

[0005] What is needed are improvements over current minimally invasive surgical methods and instruments.

Means for Solving the Problems

[0006] In one embodiment, the guide is configured to align a bone having a first portion and a second portion surgically separated from the first portion. The guide may include a main body portion defining an inner surface facing the bone and an outer surface opposite to the inner surface. The guide may define a plurality of main body portion openings extending through the main body portion from the outer surface to the inner surface. The guide further includes an alignment portion extending from the main body portion, the alignment portion defining an inner surface facing each bone and an outer surface opposite to each inner surface. The guide may define a plurality of alignment openings extending through the alignment portion from each outer surface to each inner surface. The guide may include a handle portion, the handle portion extending from the main body portion such that the alignment portion and the handle portion extend from both ends of the main body portion. The guide may be sized so that at least one of the alignment openings aligns with the first portion of the bone, so that at least one of the alignment openings is configured to receive a temporary distal fixation device inserted into the second portion of the bone. The guide may be further sized to align at least one of the body portion openings with the first portion while at least one of the alignment openings is aligned with the second portion, so that at least one of the body portion openings is configured to receive a temporary proximal fixation device inserted into the first portion.

[0007] The above and other features, elements, characteristics, steps, and advantages of the present invention will become more apparent from the following detailed description of embodiments of the present invention with reference to the accompanying drawings. [Brief explanation of the drawing]

[0008] [Figure 1] These are front, top, and right-side perspective views of a main fragment guide configured according to one embodiment. [Figure 2A] Figure 1 shows the rear, bottom, and left-side perspective views of the main fragment guide. [Figure 2B] Figure 1 shows another front, top, and right-side perspective view of the main fragment guide. [Figure 2C] Figure 1 shows another rear, bottom, and left-side perspective view of the main fragment guide. [Figure 2D]Figure 1 shows the front, bottom, and right-side perspective views of the main fragment guide. [Figure 2E] Figure 1 is a right-side elevation view of the main fragment guide. [Figure 2F] Figure 1 is a left elevation view of the main fragment guide. [Figure 2G] Figure 1 is a top view of the main fragment guide. [Figure 2H] Figure 1 is a bottom view of the main fragment guide. [Figure 2I] Figure 1 is a rear elevation view of the main fragment guide. [Figure 2J] Figure 1 is a front elevation view of the main fragment guide. [Figure 2K] This is a cross-sectional elevation view of the main fragment guide taken around line 2K-2K in Figure 2G. [Figure 3A] This is a perspective view of the main fragment guide constructed by another embodiment. [Figure 3B] Figure 3A is another perspective view of the main fragment guide. [Figure 4A] A perspective view of the first K-wire extending through a sizing guide within the first metatarsal bone of the foot of a patient with a bunion during surgical bunion correction procedure. [Figure 4B] Figure 4A is a perspective view showing the sizing guide removed so that the first K-wire extends into the first metatarsal bone of the patient's foot. [Figure 5A] Figure 4B is a perspective view of the major fragment guide in Figure 1 aligned with the distal portion of the first metatarsal bone of the patient's foot, with the distal portion marked to define the major fragment of the first metatarsal bone. [Figure 5B] Figure 5A is a perspective view of the patient's foot, showing how two K-wires are driven into the distal portion of the first metatarsal bone through the alignment opening of the major fragment guide. [Figure 6] Figure 5B is a perspective view of the patient's foot, showing the major fragment guide removed while the two k-wires remain inserted in the distal portion of the first metatarsal bone. [Figure 7A]A perspective view of a cutting guide configured to receive a cutting instrument used to cut or excise the first intermediate metatarsal bone so as to separate the distal portion of the first intermediate metatarsal bone, thereby defining a major fragment of the first intermediate metatarsal bone separated from the proximal portion of the first intermediate metatarsal bone. [Figure 7B] Another perspective view of the cutting guide of FIG. 7A. [Figure 8A] A perspective view of a patient's foot of FIG. 6, showing the cutting guide of FIG. 7A being guided along the first K-wire of FIG. 4B to the interface between the proximal portion and the distal portion of the first intermediate metatarsal bone. [Figure 8B] A perspective view of a patient's foot of FIG. 8A, showing the cutting guide aligned with the first intermediate metatarsal bone in a predetermined position to guide a cutting instrument for cutting the first intermediate metatarsal bone. [Figure 9] A perspective view of a patient's foot of FIG. 8B, showing the cutting instrument inserted into and guided by the cutting guide to cut / excise the first intermediate metatarsal bone and define a major fragment separated from the proximal portion of the first intermediate metatarsal bone. [Figure 10A] A perspective view of a patient's foot of FIG. 9, showing the cut / excised first intermediate metatarsal bone, and further showing the implant connected to an inserter and aligned to be inserted into the distal end of the proximal portion of the intermediate metatarsal bone that is exposed by shifting the major fragment to an offset position relative to the proximal portion. [Figure 10B] A perspective view of a patient's foot of FIG. 10A, showing the implant seated on the proximal portion of the first intermediate metatarsal bone by an inserter. [Figure 10C] A perspective view of a patient's foot of FIG. 10B, showing the implant fully seated on the proximal portion of the first intermediate metatarsal bone and the inserter removed. [Figure 11A] A perspective view of a patient's foot of FIG. 10C, showing the drill guide positioned to guide a drill for creating a proximal bone fastener hole in the proximal portion of the first intermediate metatarsal bone. [Figure 11B] A perspective view of a patient's foot of FIG. 11A, showing the proximal bone fastener being driven through the implant and into the bone fastener hole in the proximal portion of the first intermediate metatarsal bone. [Figure 11C] A perspective view of a patient's foot of FIG. 11B, showing the state where the implant is fixed to the proximal portion of the first midfoot bone. [Figure 12A] A perspective view of a patient's foot of FIG. 11C, showing the state where the main fragment guide is positioned on the two K-wires shown in FIG. 5B such that the two K-wires extend through the main fragment guide. [Figure 12B] A perspective view of a patient's foot of FIG. 12A, showing the adjustment of the main fragment from a misaligned position to an aligned position with respect to the proximal portion using the main fragment guide. [Figure 12C] A perspective view of a patient's foot of FIG. 12B, showing the state where the third K-wire is driven into the proximal portion of the first midfoot bone through the guide opening of the main fragment guide so that the main fragment guide positionally fixes the main fragment to the proximal portion. [Figure 12D] A side elevation view of the main fragment guide constructed according to an alternative embodiment. [Figure 13A] A perspective view of a patient's foot of FIG. 12C, showing the state where the drill guide is positioned to drill a distal bone fastener hole through the implant and into the main fragment of the first midfoot bone. [Figure 13B] A perspective view of a patient's foot of FIG. 13A, showing the state where the distal bone fastener is driven by a driver instrument through the implant and into the main fragment of the first midfoot bone. [Figure 13C] A perspective view of a patient's foot of FIG. 13B, showing the state where the distal bone fastener is fully seated in the implant and driven into the main fragment of the first midfoot bone, and showing the state where the driver instrument is removed. [Figure 14] A perspective view of a patient's foot of FIG. 13C, showing the state where the main fragment guide is removed at the completion of the surgical bunion correction procedure, and further showing the state where the two K-wires and the third K-wire are removed.

[0009] Various embodiments are shown in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of these examples. Additional embodiments can be formed by combining various features of different disclosed embodiments, and such embodiments are part of this disclosure. [Modes for carrying out the invention]

[0010] Various features and advantages of the systems, apparatus, and methods of the technology described herein will become more fully apparent from the following description relating to the illustrated embodiments. These examples are intended to illustrate the principles of the disclosure, and the disclosure should not be limited merely to the illustrated embodiments. In view of the principles disclosed herein, features of the illustrated embodiments can be modified, combined, removed, and / or replaced as will be apparent to those skilled in the art.

[0011] This disclosure relates to a major fragment guide 100 configured to be temporarily fixed to a major fragment of a first metatarsal bone excised from the proximal portion of the metatarsal bone. Therefore, for example, when the major fragment guide is moved to correct a bunion, the major fragment moves relative to the proximal portion accordingly. The major fragment guide can then be temporarily fixed to the proximal portion to fix the major fragment in position relative to the proximal portion. A permanent implant can be fixed to the proximal portion and the major fragment, and the major fragment guide can be removed.

[0012] Referring here to Figures 1 to 2K, mainly Figures 1, 2G, and 2K, the surgical system may include a main fragment guide 100. Other components of the surgical system, which may be provided as a kit or separately as desired, are described below. The main fragment guide 100 may be formed from a single material such as aluminum, plastic, steel, or other material suitable for use in a sterile surgical environment. The main fragment guide 100 may include a body portion 110, an alignment portion 120 extending from the body portion 110, and a handle portion 130 extending from the body portion 110. In one embodiment, the alignment portion 120 and the handle portion 130 may extend from both ends of the body portion 110. In one embodiment, the alignment portion 120 and the handle portion 130 may extend from the body portion 110 along their respective extension directions, which are at least substantially parallel to each other. Alternatively, the extension directions of the alignment portion 120 and the handle portion 130 may be angularly offset from each other as needed.

[0013] The main body portion 110 defines a first or proximal end 110a and a second or distal end 110b opposite the proximal end 110a along the longitudinal direction L. Therefore, “distal direction” and its derivatives can be defined as the direction from the proximal end 110a to the distal end 110b. Conversely, “proximal direction” and its derivatives can be defined as the direction from the distal end 110b to the proximal end 110a. The proximal and distal directions may each extend along the longitudinal direction L. The alignment portion 120 and the handle 130 can define the opposite end of the main fragment guide 100. For example, the alignment portion 120 may define the distal end of the main fragment guide 100, and the handle 130 may define the proximal end of the main fragment guide 100.

[0014] As can be understood from the following description, the distal end 110b may be separated from the proximal end 110a in the anatomically distal direction when placed against the first metatarsal bone. In one embodiment, the alignment portion 120 may extend distally from the distal end 110b of the main body portion 110, and the handle portion 130 may extend proximal to the proximal end 110a of the main body portion 110. The main fragment guide 100, which includes the main body portion 110, the alignment portion 120, and the handle portion 130, will now be described in more detail.

[0015] The main fragment guide 100 defines a bone-facing inner surface 105 configured to face the underlying metatarsal bone, and an outer surface 106 located opposite the inner surface 105 along the transverse direction T, which is perpendicular to the longitudinal direction L. The inner surface 105 may be at least partially defined by the bone-facing inner surface 111 of the main body portion 110 configured to face the underlying metatarsal bone, and the bone-facing inner surface 121 of the alignment portion 120 configured to face the underlying metatarsal bone. In some embodiments, the inner surface 105 of the main fragment guide may be further defined by the inner surface 133 of the handle portion 130. The outer surface 106 of the main fragment guide 100 may be at least partially defined by the outer surface 112 of the main body portion 110 located opposite the inner surface 105 along the transverse direction T, and the outer surface 122 of the alignment portion located opposite the inner surface along the transverse direction T. In some embodiments, the outer surface 106 of the main fragment guide 100 may be further defined by the outer surface 137 of the handle portion 130, which is opposite the inner surface 133 along the transverse direction T. Thus, the inner surface 105 and the outer surface 106 may extend along the body portion 110, the alignment portion 120, and the handle portion 130, respectively.

[0016] The main fragment guide 100 may further include first and second outer surfaces 107 and 108 that are opposite each other along a transverse direction A, which is perpendicular to the longitudinal direction L and the transverse direction T, respectively. For example, the first outer surface 107 may be separated from the second outer surface 108 along a first transverse direction extending along transverse direction A. Conversely, the second outer surface 108 may be separated from the first outer surface 107 along a second transverse direction opposite to the first transverse direction, and thus extending along transverse direction A. The first and second outer surfaces 107 and 108 extend from the inner surface 105 to the outer surface 106. The first outer surface 107 may be at least partially defined by the first outer surface 113 of the main body portion 110 and the first outer surface 127 of the alignment portion 120. The first outer surface 107 may be further partially defined by the first outer surface 138 of the handle portion 130. The second outer surface 108 can be at least partially defined by the second outer surface 114 of the main body portion 110 and the second outer surface 128 of the alignment portion 120. The second outer surface 108 can be further partially defined by the second outer surface 139 of the handle portion 130. Thus, the first and second outer surfaces 107 of the main fragment guide 100 can extend along the main body portion 110, the alignment portion 120, and the handle portion 130, respectively. In this regard, the first outer surfaces 113, 127, and 138 of the main body portion 110, the alignment portion 120, and the handle portion 130 can be separated, respectively, from the second outer surfaces 114, 128, and 139 of the main body portion 110, the alignment portion 120, and the handle portion 130 along the first lateral direction.

[0017] The main body portion 110 may have a width ranging from approximately 0.75 inches to approximately 2 inches along the lateral direction A from the first outer surface 113 to the second outer surface 114. It should be understood that in certain implementations, the main body portion 110 may include a wider or narrower width depending on the number of situations in which a particular guide is designed to be used. In one embodiment, the width of the main body portion 110 may be greater than the width of either or both of the alignment portion 120 and the handle portion 130 along the lateral direction A from their respective first outer surface to their respective second outer surface.

[0018] The primary fragment guide 100 may include a number of body portion openings 132 extending through the body portion 110. As can be seen from the following description, the body portion openings 132 may receive temporary fixation devices, such as Kirschner wires (K-wires), which positionally fix the primary fragment guide 100 to the proximal portion of the metatarsal bone. The surgeon may select the openings 132 that will receive the temporary fixation devices based, for example, on alignment with the underlying proximal bone that can reliably receive the temporary fixation devices.

[0019] The opening 132 may extend as a through hole from the outer surface 112 to the inner surface 111 of the main body portion 110. The opening 132 may extend along a straight linear central axis 129 from the outer surface 112 to the inner surface 111. Either or both of the outer surface 112 and the inner surface 111 may be planar as needed. Furthermore, the outer surface 112 and the inner surface 111 may be parallel to each other. The openings 132 may be arranged in a structured pattern such as an array 115. The array 115 may be defined by a plurality of rows 116 of one or more openings 132 spaced apart from each other along the transverse direction A. The openings 132 in each row 116 may be aligned with each other along the longitudinal direction L. Furthermore, the openings 132 in adjacent rows 116 may be offset from each other along the transverse direction A. The array 115 may be further defined by a plurality of rows 117 of one or more openings 132. Rows 117 may be oriented perpendicular to columns 116. For example, rows 117 may be oriented along the transverse direction A and spaced apart from each other along the longitudinal direction L. In some embodiments, the array 115 may contain more rows 117 than columns 116. Naturally, it should be understood that the openings 132 may be arranged in any suitable alternative array, whether patterned or not, as desired.

[0020] The main body opening 132 can be organized into various sections, including a central section 135, a first side section 134, and a second side section 136. The central section 135 may include one or more openings 132 aligned on the centerline 118 of the main body 110. The centerline 118 may extend along the longitudinal direction L and may bisect the main body 110 at an equal distance between the first outer surface 113 and the second outer surface 114. In one embodiment, the central axis 129 of one or more openings 132 of the central section 135 may intersect the centerline 118. In some embodiments, the central section 135 may include a single column of columns 116 aligned with the centerline 118, but it should be understood that the central section 135 may alternatively include one or more columns 116 adjacent to the centerline, such as columns 116 located on either side of the centerline 118.

[0021] A first side section 134 may be positioned between the central section 135 and the first outer surface 113. Therefore, one or more openings 132 of the first side section 134 may be offset toward the first outer surface 113 relative to one or more openings 132 of the central section 135. A second side section 136 may be positioned between the central section 135 and the second outer surface 114. Therefore, one or more openings 132 of the second side section 136 may be offset toward the second outer surface 114 relative to one or more openings 132 of the central section 135.

[0022] In one embodiment, the inner surface 111 and outer surface 112 of the main body portion 110 may be flat along a plane perpendicular to the transverse direction T. Alternatively, the inner surface 111 and outer surface 112 of the main body portion 110 may be flat along a plane angularly offset with respect to the transverse direction T. The central axis 129 of one or more, up to all, of the openings 132 may each be oriented perpendicular to either or both of the inner surface 111 and outer surface 112. In another embodiment, the central axis 129 of one or more, up to all, of the openings 132 may each define a non-perpendicular angle with respect to either or both of the inner surface 111 and outer surface 112. The non-perpendicular angle of a given central axis 129 with respect to the inner surface 111 and outer surface 112 may be measured in any plane containing the given central axis 129.

[0023] In another embodiment, the inner surface 111 and outer surface 112 of the main body portion 110 may be non-planar as desired. The central axis 129 of one or more, up to all, of the openings 132 may be oriented substantially parallel to the transverse direction T. In another embodiment, the central axis 129 of one or more of all the openings 132 may define an angle with respect to the transverse direction T. The angle may be the same for all the openings 132, or it may differ for one or more openings 132 with respect to the other openings 132. The angle may be measured in any plane including the transverse direction T.

[0024] Therefore, it should be understood that in some embodiments, the central axes 129 of all the openings 132 may be parallel to each other. In other embodiments, one or more central axes 129 of the openings 132 may be angularly offset with respect to the central axes 129 of one or more other openings 132, as desired. For example, the central axes 129 of the openings 132 in each section may be parallel to each other and angularly offset with respect to the central axes 129 of the openings 132 in another section. Alternatively or additionally, the central axes 129 of the openings 132 in each column 116 may be parallel to each other and angularly offset with respect to the central axes 129 of the openings 132 in another column 116. Alternatively or further additionally, the central axes 129 of the openings 132 in each row 117 may be parallel to each other and angularly offset with respect to the central axes 129 of the openings 132 in another row 117. In yet another embodiment, the central axis 129 of at least one opening 132 in a given section, column 116, and / or row 117 may be angularly offset with respect to the central axis 129 of at least one other opening 132 in the given section, column 116, and / or row 117.

[0025] Continuing to refer to Figures 1 to 2K, as described above, the guide 100 may include an alignment portion 120 extending from the main body portion 110. For example, the alignment portion 120 may extend distally from the distal end 110b of the main body portion 110. In one embodiment, the alignment portion 120 may define a monolithic, integrated structure with the main body portion 110. Alternatively, the alignment portion 120 may be separate and fixed to the main body portion 110. The alignment portion 120 extends from the main body portion 110 to the free end portion 123. The alignment portion 120 may be roughly aligned along the centerline 118 of the main body portion 110.

[0026] The primary fragment guide 100 may include a plurality of alignment openings 124 extending from the outer surface 122 to the inner surface 121 through the alignment portion 120. The alignment portion 120 may have a height from the outer surface 112 to the inner surface 111 that is greater than the height of the guide portion 110 from the outer surface 122 to the inner surface 121. The openings 124 may extend along their respective straight linear central axes 126 from the outer surface 122 to the inner surface 121. As can be understood from the following description, the alignment openings 124 may receive temporary fixation devices, such as K-wires, which positionally fix the primary fragment guide 100 to the primary fragment of the metatarsal bone. The surgeon may select an opening 132 that will receive the temporary fixation device based, for example, on alignment with the bone of the underlying distal fragment portion that can reliably receive the temporary fixation device. As will be explained in more detail below, positional manipulation of the main fragment guide 110, particularly the alignment portion 120, can cause a corresponding positional manipulation of the distal fragment portion relative to the proximal portion of the metatarsal bone when the main body portion 110 is not temporarily fixed relative to the proximal portion.

[0027] Multiple aligned openings 124 can be aligned in at least one row 125 oriented along the longitudinal direction L. In one embodiment, the aligned openings 124 are aligned in a single row 125 oriented along the longitudinal direction L. The row 125 can be aligned with the central section 135 of the body portion opening 132 along the longitudinal direction L. Thus, the central axis 126 of each aligned opening 124 can be located on the center line 118. It should be understood that the row 125 can alternatively be oriented along a direction angularly offset with respect to the longitudinal direction L, and thus angularly offset with respect to the central section 135 of the body portion opening 132. The openings 124 can be aligned with each other along the row 125. Alternatively, the openings 124 can be arranged in a staggered pattern with respect to each other along the row 125. In yet another embodiment, the openings 124 can be arranged in two or more rows. In this regard, the openings 124 can be arranged in any suitable array as desired.

[0028] In one embodiment, adjacent alignment openings 124 may be spaced about 0.25 inches to 1.25 inches apart. As illustrated, a plurality of openings 124 may include four openings or any other number of openings as desired. The openings 124, and all openings described herein as configured to receive a K-wire, may be sized for the k-wire intended to be received therein. In one embodiment, the K-wire may have a diameter of 0.062 inches, and the opening 124 may have a diameter of about 0.069 inches. Naturally, it should be understood that the alignment openings 124 and all K-wire receiving openings described herein may be sized to receive k-wires of any size. Thus, in one embodiment, the openings may have diameters ranging from about 0.040 inches to about 0.125 inches. The central axes 126 of the alignment openings 124 may be oriented parallel to each other and parallel to the body portion openings 132. For example, the central axes 126 may be oriented along the transverse direction T. Alternatively, the central axis 126 may be oriented along an angular direction that is angularly offset with respect to the transverse direction T. The angular direction may be defined within any plane extending along the central axis 126. Furthermore, the central axis 126 of the opening 124 may be oriented perpendicular to either or both of the inner surface 121 and the outer surface 122.

[0029] The inner surface 121 may include one or more inclined surface portions, such as a first or proximal inclined surface portion 121a and a second or distal inclined surface portion 121b distally separated from the proximal inclined surface portion 121a. In one embodiment, the inner surface 121 may include an intermediate surface portion 121c extending between the proximal inclined surface portion 121a and the distal inclined surface portion 121b. Alternatively, the distal inclined surface portion 121b may extend from the proximal inclined surface portion 121a. Each of the proximal inclined surface portion 121a and the distal inclined surface portion 121b may extend outward toward the outer surface 122 as it extends distally. The distal inclined surface portion 121b may extend toward the outer surface 122 at a larger, smaller, or substantially equal angle to that of the proximal inclined surface portion 121a. The proximal inclined surface portion 121a may curve as it extends along the longitudinal direction L. In one embodiment, none of the aligned openings 124 extend to the distal inclined surface portion 121b. Alternatively or additionally, in one embodiment, none of the aligned openings 124 extend to the distal inclined surface portion 121b. It should be understood that the inclined surface may be straight or curved as needed.

[0030] The inner surface 121 may further include a third or aligned surface portion 121d that is aligned with the inner surface 111 of the main body portion 110 and therefore coplanar. The aligned surface portion 121d may be parallel to the intermediate surface portion 121c as necessary. Alternatively, the third surface portion 121d may be angularly offset with respect to the inner surface 111. The aligned surface portion 121d may extend distally from the inner surface 111 of the main body portion 110, and the proximal inclined surface portion 121a may extend distally from the aligned surface portion 121c. In one embodiment, all openings 124 may extend to the aligned inner surface portion 121d. Alternatively, one or more of the openings 124 may extend to the proximal inclined surface portion 121a. Alternatively or additionally, one or more of the openings 124 may extend to the distal inclined surface portion 121b.

[0031] The outer surface 122 of the aligned portion 120 may extend from the outer surface 112 of the main body portion 110. The outer surface 122 may be parallel to the outer surface 112 and offset from the outer surface 112 in a transverse outward direction defined from the inner surface 111 toward the outer surface 112. Alternatively, the outer surface 122 may be angularly offset from the outer surface 112. In yet another embodiment, the outer surfaces 122 and 112 may be aligned and therefore coplanar with each other.

[0032] Continuing to refer to Figures 1 to 2K, as described above, the main fragment guide 100 may include a handle portion 130 extending from the proximal end 110a of the main body portion 110. The handle portion 130 may provide at least one grip section 131 configured to be grasped by the surgeon for positional manipulation of the main fragment guide 100. The grip section 131 may define a greater frictional force with the surgeon's hand compared to other sections of the handle portion 130. In particular, the grip section 131 may be defined on the outer circumference of the handle portion and may extend outward along a first lateral direction with respect to a first outer surface 138 of the handle portion 130 and along a second lateral direction with respect to a second outer surface 139. Thus, the first and second outer surfaces 138 and 139 may be recessed relative to the grip portion 131. The grip section 131 may be ribbed or otherwise textured as desired. The handle portion 130 may include a raised, curved knob 140 that extends outward from the outer surface 112 of the main body portion 110 (along the direction from the inner surface 105 to the outer surface 106). Therefore, the handle portion 130 may be easier to grip and operate. The handle portion 130 and the alignment portion 120 may each have a width along the lateral direction A that is smaller than the width of the main body portion 110. For example, the width of the handle portion 130 may be in the range of about 0.25 inches to about 1 inch along the lateral direction A. The width of the alignment portion 120 may be substantially equal to the width of the handle portion 130.

[0033] Continuing to refer to Figures 1 to 2K in general, either or both of the first outer surface 113 and the second outer surface 114 of the main body portion 110 may include ribs 141 or other surface textures to facilitate the surgeon's grip of the main body portion 110. The ribs 141 may be elongated along the transverse direction T or any other direction as desired. The ribs 141 may be spaced apart from each other along the longitudinal direction L or any other direction as desired. As shown in Figure 3, the first and second outer surfaces 113 and 114 of the main body portion 110 may be smooth instead. The grip section 131 may also terminate at a position aligned with the first and second outer surfaces 138 and 139 of the handle portion 130. The main fragment guide 100 in Figure 3 may be constructed in other ways as illustrated and described with reference to Figures 1 to 2K.

[0034] Next, with reference to Figures 4A to 15, surgical techniques using the main fragment guide 100 will be described. Referring first to Figure 4A, the patient's foot 20 includes a metatarsal bone 22 and a proximal phalanx 24 containing a bunion 26 or other deformity. The metatarsal bone 22 may be the anatomical first metatarsal bone. It should be understood that the metatarsal bone 22 may, alternatively, be any metatarsal bone, especially if the proximal phalanx 24 contains a non-bunion deformity. In the illustrated embodiment, the angle between the metatarsal bone 22 and the proximal phalanx 24 may form an unpleasant bunion and hallux valgus, which can be corrected using surgical techniques as described herein. The embodiments and methods described herein will be described primarily in conjunction with surgical methods and instruments for correcting bunions and hallux valgus. However, the instruments and methods described herein may also be used in conjunction with other parts of the body to reorient and fix bone fragments. Therefore, the metatarsal bone 22 can be understood as the first bone, and the proximal phalanx 24 can be understood as the second bone. Similarly, the metatarsal bone 22, which has been resected and separated into a proximal portion and a distal major portion, as described below, can be understood as being applicable to the first bone, which has been separated into the first and second portions by resection, respectively. Furthermore, the major portion guide 100 can be called the guide.

[0035] As shown in Figures 4A and 4B, the surgical system may further include a first temporary fixation device, such as a first K-wire 28, which can be inserted into a desired position 27 of the metatarsal bone 22. As will be understood from the following description, the desired position 27 may be the position where the metatarsal bone is resected. The incision may be made in the patient's skin and soft tissue so that the first K-wire can be inserted through the incision into the desired position 27 of the metatarsal bone 22. The desired position 27 may coincide with a marked location so as to be on the cut surface separating the proximal portion 22a of the metatarsal bone 22 from the distal portion 22b of the metatarsal bone 22. Once the distal portion 22b of the metatarsal bone 22 is separated from the proximal portion 22a, the distal portion 22b defines the major fragment, as will be described in more detail below. In this regard, the first K-wire 28 may be called the cut surface K-wire 28 or temporary cut surface fixation device. It should be understood that this disclosure may apply to any bone in addition to the metatarsal bones, and therefore the proximal portion 22a may be referred to as the first portion or proximal portion of the bone, the distal portion 22b may be referred to as the second portion or distal portion of the bone, and the principal fragment may be referred to as the separated second portion or distal portion of the bone separated from the first portion or proximal portion of the bone.

[0036] In one embodiment, the first K-wire 28 is driven to a desired position 27 by any suitable instrument as desired. A sizing guide 30 may then be placed on the first K-wire 28 to determine the size of the proximal portion 22a which will determine the corresponding size of a permanent implant to be placed later (see implant 52 in Figures 10A-10C). The sizing guide 30 may include a sizing guide body 32 and a sizing guide opening 34 which extends through the sizing guide body 32 along its respective central axis and is sized to receive the K-wire 28. The sizing guide opening 34 may have a diameter substantially equal to the diameter of the first K-wire 28, so that the first K-wire 28 can only be translated within the sizing guide body 32 along the central axis of the sizing guide opening 34 as it moves through the sizing guide opening 34. Thus, translation of the K-wire 28 along a direction angularly offset with respect to the central axis of the sizing guide opening 34, and corner formation of the K-wire 28 within the sizing guide opening 34 are substantially prevented. The sizing guide 30 may be roughly aligned with the metatarsal bone 22 such that the sizing guide opening 34 aligns with a desired position 27 along a desired trajectory defined by the central axis of the sizing guide opening 34. The sizing guide 30 may include two or more size indicators 35 that the surgeon can visually examine during use to determine the appropriate sizing of the permanent implant.

[0037] During operation, the first K-wire 28 can be driven to a desired position 27 on the metatarsal bone 22 in the insertion direction. If the K-wire is threaded, the K-wire 28 can be rotated to screw the first K-wire 28 into the metatarsal bone 22 as the K-wire moves into the metatarsal bone 22. Alternatively, the K-wire 28 may have a smooth outer surface that contacts the metatarsal bone 22. The sizing guide 30 can then be positioned on the first K-wire 28 by inserting the free end of the K-wire 28 into the sizing guide opening 34 and moving the sizing guide 30 toward the metatarsal bone 22 to a position where the sizing guide 30 is sufficiently close to and adjacent to the metatarsal bone so that the surgeon can properly measure the size indicator 35 relative to the metatarsal bone. The trajectory of the first K-wire 28 guides the sizing guide 30 toward the metatarsal bone 22, resulting in the sizing guide opening 34 being brought to a position aligned with the desired position 27 along the central axis of the first K-wire 28.

[0038] When the sizing guide 30 is positioned adjacent to the metatarsal bone 22, the surgeon can determine the size of the permanent implant. Each size indicator 35 is positioned at a different distance from the sizing guide opening 34 along the length of the sizing guide 30 (and therefore along the length of the metatarsal bone 22). The kit may include multiple permanent implants corresponding to different indicators of the size indicator 35. Thus, when the sizing guide 30 is positioned adjacent to the metatarsal bone 22, the surgeon can identify which size indicator 35 best matches the length of the proximal portion of the metatarsal bone 22. The surgeon can then select the permanent implant corresponding to the identified size indicator 35. In one embodiment, the sizing guide includes two size indicators 35, each containing a letter or graphic mark such as "S" or "L" corresponding to "small" and "large" implant sizes, respectively. It should be understood that the size indicators 35 may, if desired, include any preferred graphical representation, including distances correlated to the corresponding permanent implant length or size. Once the permanent implant is sized, the sizing guide 30 can be removed from the foot 20 by sliding the sizing guide 30 along the first K-wire 28 in a removal direction away from the foot 20 until the sizing guide 30 is removed from the first K-wire. The first K-wire 28 may remain inserted into the metatarsal bone 22 at a desired position 27, as shown in Figure 4A.

[0039] Referring here to Figures 5A and 5B, the surgical system may further include one or more temporary fixation devices, such as a pair of temporary fixation devices which may constitute K-wires 36. The K-wires may be inserted into the distal portion 22b of the metatarsal bone 22, which is marked to define the main fragment when the metatarsal bone 22 is later cut. That is, the K-wires 36 may be inserted percutaneously into the metatarsal bone 22 at their respective locations distal to the first K-wire 28. The respective locations may be separated from each other in the anatomical proximal-distal direction. Furthermore, the K-wires 36 may be oriented substantially parallel to each other.

[0040] In one embodiment, the K-wire 36 is first inserted into the distal portion 22b by moving the main fragment guide 100 to a position aligned with the metatarsal bone 22 so that one or more of the alignment openings 124 align with the distal portion 22b of the metatarsal bone 22 along a trajectory such that one or more of the alignment openings 124 are defined by the central axis of the alignment openings 124. The main fragment guide 100 may be located outside the incision and therefore outside the patient's body, including the metatarsal bone 22. The alignment openings 124 may have a diameter substantially equal to the diameter of the K-wire 36 so that the K-wire 36 can only translate along the central axis 126 of the alignment openings 124 as it moves through the alignment openings 124.

[0041] The first K-wire 36 is driven in its respective insertion direction to the metatarsal bone 22 through each selected alignment opening 124 of a plurality of alignment openings 124, and then the K-wire 36 may be rotated to contact the metatarsal bone 22 as it moves in the insertion direction into the distal portion 22b of the metatarsal bone 22. In one embodiment, the K-wire 36 and other K-wires disclosed herein have a smooth surface that contacts the underlying bone. In other embodiments, the K-wire may have a threaded surface that screws into the underlying bone by rotating the K-wire as it is driven into the underlying bone. The K-wire 36 may be driven through alignment openings 124 that are reliably aligned with bone for contact with the K-wire 36. As the K-wire 36 is driven through each alignment opening 124 and into the distal portion 22b of the metatarsal bone, the main body portion 110 may align with the proximal portion 22a of the metatarsal bone 22. Since the K-wire 36 is inserted into the distal portion 22b of the metatarsal bone 22, the K-wire 36 may be referred to as a distal K-wire or distal temporary fixation member. Any number of K-wires 36, such as at least one, may be inserted into the distal portion 22, but as will be explained in more detail below (see Figures 12A and 12B), it is understood that at least a pair of K-wires 36 can give the major fragment guide 100 better control over the positional manipulation of the major fragment 22c. Furthermore, at least one K-wire 36 allows the surgeon to easily position and identify the major fragment 22c in subsequent surgical steps, which may be particularly advantageous in minimally invasive surgery with small incisions.

[0042] Referring here to Figure 6, once the K-wire 36 is driven into the distal portion 22b of the metatarsal bone 22, the main fragment guide 100 can be removed by sliding the main fragment guide 100 along the K-wire 36 in the removal direction opposite to the insertion direction of the K-wire 36. The K-wire 36 remains inserted into the distal portion 22b of the metatarsal bone 22. It is understood that both the insertion and removal directions can be defined by the central axis 126 of the alignment opening 124. As can be understood from the following description, since the K-wire 36 has been driven through the alignment opening 124, the main fragment guide 100 can later be positioned on the metatarsal bone 22 so that the K-wire 36 can be received again by the alignment opening 124.

[0043] Referring here to Figures 7A to 8B, the surgical system may further include a cutting guide 38 configured to guide a cutting instrument to cut the metatarsal bone along a desired cutting plane. The cutting guide 38 may include a cutting guide body 40 defining an inner surface 40a facing the bone and an outer surface 40b opposite to the surface 40a facing the bone. The cutting guide may include a first opening or central opening 42 extending through the cutting guide body 40 from the outer surface 40b to the inner surface 40a along the central axis of the first opening 42. The first opening 42 is sized and configured to receive a first K-wire 28. The first opening 42 may have a diameter substantially equal to the diameter of the first K-wire 28. Thus, translation of the first K-wire 28 within the first opening 42 can occur relative to the cutting guide 38 only along the central axis of the first opening 42.

[0044] The cutting guide 38 may further include a cutting slot 44 extending from the outer surface 40b to the inner surface 40a through the cutting guide body 40. The cutting slot 44 may be positioned at a known location relative to the first opening 42. Thus, when the first opening 42 receives the first K-wire 28, the cutting slot 44 may align with the metatarsal bone at a location determined to be excised by the cutting instrument. Thus, the location to be excised may include a desired position 27 of the first K-wire 28 (see Figures 4A and 4B). The cutting slot 44 may define a length measured along a direction extending along either or both of the inner surface 40a and the outer surface 40b. The cutting slot 44 may define a width perpendicular to its length and smaller than its length. In one embodiment, the inner portion of the first opening 42 may be defined by the cutting slot 44, while the outer portion of the first opening 42 extends beyond the width of the cutting slot 44. In particular, the diameter of the first opening 42 may be sized to be larger than the width of the cutting slot 44. As a result, when the first K wire 28 extends through the first opening 42, the first K wire is prevented from translating or forming an angle along the length of the cutting slot 44.

[0045] In another embodiment, the first opening 42 may be spaced a known distance away from the cutting slot 44. Thus, in this embodiment, the desired position 27 of the first K-wire 28 (see Figures 4A and 4B) may be spaced a known distance away from the cutting slot. Thus, when the first K-wire 28 is received by the first opening 42 of the cutting guide 38 spaced a known distance away from the cutting slot 44, the cutting slot 44 may be aligned with the cutting surface of the metatarsal bone to be cut. It should be understood that the desired position of the first K-wire and the cutting surface of the metatarsal bone may be marked as part of the pre-planning before the surgical procedure, or may be identified in real time by the surgeon during the surgical procedure.

[0046] The cutting guide 38 may further include at least one mounting opening 46 that extends through the cutting guide body 40 from the outer surface 40b to the inner surface 40a. The cutting guide 38 is recognized as positionally fixed to the metatarsal bone 22 when it is fixed to the metatarsal bone at two different fixing points (see Figure 8B). One of the fixing points may be defined by a temporary fixing device, such as a fixing K-wire 48, which is driven through the mounting opening 46 and into the metatarsal bone 22. When the first opening 42 is spaced away from the cutting slot 44, the other of the fixing locations may be defined by the first K-wire 28. Thus, in some embodiments, the cutting guide 38 may include only a single mounting opening 46.

[0047] When the first opening 42 aligns with the cutting slot 44, the first K-wire 28 is removed before cutting the metatarsal bone 22 through the cutting slot 44. Thus, the cutting guide 38 may include a pair of mounting openings 46 spaced apart from each other and receiving their respective mounting K-wires 48, to ensure that the cutting guide 38 is positionally fixed against movement along the metatarsal bone 22. In one embodiment, the cutting slot 44 may be positioned between the mounting openings 46. The mounting openings 46 may have a diameter substantially equal to the diameter of the temporary mounting device that may constitute the mounting K-wire 48. Thus, as the mounting K-wires 48 are driven into the metatarsal bone 22 through the mounting openings 46, the cutting guide 38 is prevented from moving along the metatarsal bone 22. Embodiments of the cutting guide 48 are shown and described with reference to Figures 4–8 and 14A–14E of U.S. Patent Publication No. 2021 / 0038260 (which is incorporated in its entirety by reference). The surgical system may further include a K-wire 48.

[0048] Continuing to refer to Figures 7A to 8B, during operation, the cutting guide 38 is inserted through the incision and placed on the metatarsal bone 22 so that the first opening 42 receives the first K wire 28. Next, the cutting guide 38 can rotate about an axis of rotation that can be defined by the first K wire 28 to align the cutting plane and the cutting slot 44 to be cut so as to separate the proximal portion 22a from the distal portion 22b of the metatarsal bone 22. When the first opening 42 is partially defined by the cutting slot 44, the mounting K wire 48 can be driven through the mounting opening 46 and into the metatarsal bone to fix the cutting guide 38 in position, thereby aligning the cutting slot 44 with the desired cutting plane. Since the attachment openings 46 may be located on both sides of the cutting slot 44, it should be understood that one of the attachment K-wires 48, the proximal one, is driven through one of the attachment openings 46 and into the proximal metatarsal portion 22a, and one of the attachment K-wires 48, the distal one, is driven through the other of the attachment openings 46 and into the distal metatarsal portion 22b.

[0049] Referring here to Figures 8B to 9, the first K-wire 28 can then be removed from the metatarsal bone 22 to expose the entire cutting slot 44. The attached K-wire 48 provides two anchoring points for the cutting guide 38 to the metatarsal bone 22, so that the cutting guide 38 cannot be translated or angled along the metatarsal bone. Thus, the cutting slot 44 remains aligned with the marked cutting plane. In other embodiments where the first opening 42 is separated from the cutting slot 44, the first K-wire 28 may remain inserted into the first opening during the cutting procedure as the underlying metatarsal bone 22, and only the single attached K-wire 48 and the first K-wire 28 may provide two anchoring points for stabilizing the cutting guide 38.

[0050] Next, referring also to Figure 9, the cutting instrument 50 can cut the metatarsal bone 22, thereby dividing the metatarsal bone into a proximal portion 22a and a major fragment 22c. The major fragment 22c is predefined by the distal portion of the metatarsal bone 22. The cutting instrument 50 may consist of a saw, reamer, bur, or any preferred alternative instrument. The surgical system may further include a fitted cutting instrument 50. The major fragment 22c is defined by the distal portion 22b, which is excised and separated from the proximal portion 22a. The cutting instrument 50 may be inserted into the metatarsal bone 22 within the cutting slot 44 and along the marked cutting plane. The movement of the cutting instrument 50 along the cutting plane through the metatarsal bone 22 separates the distal portion 22b of the metatarsal bone 22 from the proximal portion 22a, and as a result, the distal portion 22b defines the major fragment 22c. Next, the cutting instrument 50 can be removed from the cutting guide 38, and the cutting guide 38 and the attached K-wire 48 can be removed from the metatarsal bone 22. The cutting guide 38 can be removed from the attached K-wire 48 in the direction opposite to the insertion direction, and then the attached K-wire 48 can be removed from the metatarsal bone 22. Alternatively, the attached K-wire 48 can be removed from the metatarsal bone 22, and then the assembly of the K-wire 48 and the cutting guide 38 can be removed. The other distal K-wire 36 can be grasped to stabilize the main fragment 22c while removing the distal attached K-wire 48 from the main fragment 22c, if necessary. We have described a procedure for separating the distal portion of a metatarsal bone from its proximal portion and manipulating the distal portion relative to the proximal portion to align it with the proximal portion. Please understand that this procedure can be applied to any bone as desired, thereby separating the second portion from the first portion of the bone so that the second portion of the bone defines the separated second portion, and manipulating the separated second portion of the bone relative to the first portion of the bone to align it with the first portion.

[0051] Referring here to Figures 10A-10C, the surgical system may further include an implant 52 configured to fix the proximal portion 22a of the metatarsal bone 22 to the major fragment 22c after the major fragment 22c has been repositioned to correct the bunion 26. The implant 52 may include a nail portion 54, a neck 56 extending from the nail portion 54, and a head 58 extending from the neck 56. The nail portion 54, the neck 56, and the head 58 may define a single, integrated monolithic body. The nail portion 54 may be sized and configured to be inserted into the pulpoid canal of the proximal portion 22a of the metatarsal bone 22 through the distal end of the pulpoid canal. The head 58 may extend along the major fragment 22c and define a distal fixation opening 62 configured to receive a bone fixation element for fixing the implant 52 to the distal portion 22b. The head 58 may also be configured to be detachably connected to an inserter 64. The neck 56 may extend from the nail portion 54 to the head 58. The neck 56 may further define a proximal fixation opening 60 configured to receive a bone fixation element for fixing the implant 52 to the proximal portion 22a. The proximal fixation opening 60 may extend through the neck 56 of the implant 52. The distal fixation opening 62 may extend through the head 58 of the implant 52. As will be described in more detail below, the implant 52 may be fixed to the proximal portion 22a, the main segment 22c may be manipulated to a desired position, and then the implant 52 may be fixed to the main segment 22c to fix the distal portion to a desired position.

[0052] Referring particularly to Figure 10A, the implant 52 may be removably connected to an inserter 64, which may be included in the surgical system. In some embodiments, the inserter 64 may be defined by the same instrument that defines the guide 30 (see Figure 4A). Alternatively, the insertion portion 64 may be defined by a separate instrument as needed. The inserter 64 may be manipulated so that the nail portion 54 aligns with the distal end of the pulp canal in the proximal portion 22a of the metatarsal bone 22. The main segment 22c may be moved or shifted to an offset position relative to the proximal portion 22a to expose the distal end of the pulp canal, thereby providing access for the nail portion 54 to be inserted into the pulp canal through the distal end. Manual force may be applied to the main segment 22c, thereby moving and shifting the main segment 22c laterally to an offset position relative to the proximal portion 22a.

[0053] As shown in Figure 10B, the inserter 64 can drive the nail portion 54 of the implant 52 into the pulp canal until the nail portion 54 is fully seated in the pulp canal. Then, as shown in Figure 10C, the inserter 64 can be removed. The implant 52 can be fully seated in the pulp canal such that the proximal fixation opening 60 is aligned with the proximal portion 22a of the metatarsal bone 22 and the distal fixation opening 62 is aligned with the distal portion 22b of the metatarsal bone 22. In particular, the implant 52 may be positioned so that the surgeon has easy access to the openings 60 and 62 for inserting the respective bone fixation elements through its interior. Furthermore, the openings 60 and 62 may be positioned where the anatomical structure best accommodates the bone fixation elements. For example, the openings 60 and 62 may be positioned roughly aligned with the medial surface of the metatarsal bone 22. The implant 52 may include an outwardly extending handle 66 that the surgeon can grasp to help position the implant 52 as desired.

[0054] Referring here to Figures 11A-11C, once the implant 52 is inserted into its desired position within the proximal portion 22a of the metatarsal bone 22, the implant 52 can be permanently fixed to the proximal portion 22a. The term “permanently” is used to indicate that fixation remains after the completion of the surgical procedure. During operation, as shown in Figure 11A, the handle 68 may support the drill guide 67, which receives a drill that can be driven through the proximal fixation opening 60 and into the proximal portion 22a of the metatarsal bone 22 to form a hole for receiving the bone fixator. As shown in Figure 11B, the driver instrument 69 may drive the proximal bone fixator 70 through the proximal fixation opening 60 and into the hole created in the proximal portion 22a. In other embodiments, the proximal bone fixator 70 can be driven into the proximal portion 22a without first preparing a hole in the proximal portion 22a. The handle 68 may be defined by the same instrument that defines the guide 30 (see Figure 4A) and the inserter 64 (see Figures 10A and 10B). Alternatively, the handle 68 may be defined by a separate instrument as needed.

[0055] The surgical system may include a proximal bone fastener 70. The central axis of the proximal fixation opening 60 may extend along a trajectory oriented laterally and posteriorly. Thus, the proximal bone fixation opening may be referred to as oblique. The proximal bone fastener 70 may be driven along the central axis of the proximal fixation opening 60 (e.g., laterally and posteriorly), through the proximal fixation opening 60, and into the proximal portion 22a. Thus, the proximal bone fastener 70 may also be referred to as oblique. In one embodiment, the proximal bone fastener 70 may be configured as a proximal bone screw having a threaded shaft 72 that screws into the proximal portion 22a. The bone fastener 70 may include a head (not shown) that seats against the implant 52 in the proximal fixation opening 60. The head may not be threaded so as to provide compression to the implant 52 when the proximal bone screw is driven into the proximal portion 22a. In some embodiments, the head may be threaded to screw into the implant 52 in the proximal fixation opening 60. Once the bone fixator is seated against the implant and inserted into the proximal portion 22a, the implant 52 is attached to and fixed to the proximal portion 22a against relative movement. Thus, movement of the implant 52 relative to the proximal portion 22a is prevented. The implant 52 is not attached to the main segment 22c so that the main segment 22c is movable relative to the proximal portion 22a.

[0056] Referring here to Figures 12A to 12C, at least one distal K wire 36 can be moved relative to the proximal portion 22a, and therefore, the main segment 22c can be moved and repositioned accordingly to align with the proximal portion 22a, thereby eliminating the bunion 26 (see Figure 4). In one embodiment, the main segment guide 100 can be temporarily connected to the main segment 22c such that the movement of the main segment guide 100 relative to the proximal portion 22a moves the main segment 22c correspondingly relative to the proximal portion 22a. For example, the main segment guide 100 can be reconnected to the distal K wire 36 which remains temporarily fixed to the main segment 22c.

[0057] The main fragment guide 100 can be repositioned on the distal K-wire 36 so that the distal K-wire 36 is again received in each of the alignment openings 124. In particular, the K-wire 36 can be received in the alignment opening 124 into which the K-wire 36 was pre-inserted when it is pre-fixed to the distal portion 22b, as described above with respect to Figures 5A and 5B. Alternatively, the K-wire 36 can be received by a different alignment opening 124 than the one into which the K-wire 36 was pre-inserted when it is fixed to the distal portion 22b (for example, when all the alignment openings 124 are spaced the same distance apart from each other). Once the K-wire 36 is received in each of the alignment openings 124, the main body portion 110 of the main fragment guide 100 can be positioned on the proximal portion 32a so that at least one of the main body portion openings 132 aligns with the proximal portion 32a along its respective central axis. Therefore, once the main fragment 22c is manipulated to a desired translational and rotational alignment position relative to the proximal portion 22a, at least one K-wire can then be inserted into the proximal fragment 22a through at least one of the main body portion openings 132 to temporarily fix the distal fragment 22c to the proximal fragment 22a.

[0058] The K-wire 36 and / or the main fragment guide 100 allows the surgeon to track and reposition the main fragment 22c to provide surgical correction for the bunion, or otherwise realign or otherwise align the main fragment 22c with the proximal portion 22a. Specifically, in this case, the surgeon may grasp the handle portion 130, the body portion 110, or any other portion of the main fragment guide 100 and, accordingly, translate the main fragment guide 100, in particular the alignment portion 120, relative to the proximal portion 22a medially, laterally, posteriorly, anteriorly, or any suitable combination thereof. Alternatively or additionally, the surgeon may angle the main fragment guide 100, in particular the alignment portion 120, relative to the proximal portion 22a around any axis defined by the anatomical medial-lateral axis, the anatomical anterior-posterior axis, the anatomical superior-inferior axis, or any combination of two or all three of the anatomical axes.

[0059] Since the alignment section 120 is positionally fixed to the main segment 22c by the K wire 36, translation and / or angle formation (referred to as movement or manipulation) of the alignment section 120 corresponds to translation and / or angle formation of the K wire 36, which then translates and / or angles the main segment 22c from the initial misaligned position shown in Figure 12A to the aligned position where it aligns with the proximal segment 22a, as shown in Figure 12B, thereby eliminating bunion. Since the alignment section 120 is fixed to the body section 110 and handle 130 of the main segment guide 100, movement of the main segment guide 100 causes movement of the alignment section 120, which in turn causes movement of the main segment 22c below it. Thus, the main segment 22c can be positionally manipulated relative to the proximal segment 22a to be placed in the aligned position, thereby aligning the main segment 22c with the proximal segment 22a. In the aligned position, the major fragment 22c is more aligned with the proximal portion 22a compared to the alignment of the apices relative to the distal portion 22b before separating the distal portion 22b from the proximal portion 22a. During the alignment of the major fragment 22c, the surgeon may pay particular attention to the adjusted angles of the metatarsal bones 22 and proximal phalanges 24. In addition, the surgeon may ensure that at least one of the main body openings 132 of the main body portion 130 is aligned with the proximal portion 22b of the metatarsal bones 22. It should be understood that once the major fragment 22c is moved into the aligned position, the major fragment is positioned outside the incision and the patient's body.

[0060] In one embodiment, the alignment portion 120 is fixed to the main body portion 110 and the handle portion 130 of the main fragment guide 100, so that movement of the main fragment guide 100 causes movement of the alignment portion 120. In another embodiment, the alignment portion 120 is movable relative to the main body portion 110 and can therefore be operated independently to reposition the main fragment 22c. For example, as shown in Figure 12D, the alignment portion 120 may be attached to the main body portion 110 by a joint 143 that allows movement of the alignment portion 120 relative to the main body portion 110 by the method described herein. Thus, while the alignment portion 120 is being operated relative to the main body portion 110, one or more K-wires can temporarily fix the main body portion 110 to the proximal portion 22a.

[0061] Advantageously, since the K-wire 36 can be inserted percutaneously into the major fragment 22c in the manner described above, the major fragment guide 100 can be positioned outside the human body. Therefore, the surgical procedure can be performed minimally invasively using an incision through the metatarsal bone 22 to insert the cutting guide 38 (see Figures 7A to 8B), and an incision through the dermis and soft tissue layers adjacent to the metatarsal bone, long enough to accommodate the insertion of the implant 52 into the proximal portion of the pulposus 22a and the major fragment 22c (see Figures 10A to 10C). In one embodiment, the incision may be in the range of about 5 mm to about 30 mm, for example, about 10 mm to about 20 mm in length.

[0062] Referring here to Figure 12C, once the primary fragment 22c is moved into alignment position, it can be situally fixed to the proximal fragment 22a. In particular, at least one proximal temporary fixation device, such as a proximal K-wire 74, can be driven percutaneously through one of the openings 132 in the main body portion 110 and inserted into the underlying proximal portion 22a. It should be understood that one or more proximal K-wires 74 can be driven through each opening 132 in one or more of the sections 134-136 (see Figure 2G) of the openings 132 in the main body portion 130. The surgical system may include one or more proximal K-wires 74. The openings 132 provide the surgeon with positional flexibility so that at least one K-wire 74 is driven into the reliable bone of the proximal portion 22a in order to support at least one K-wire 74 in a position that does not interfere with the implant 52 and the proximal bone fixation device 70. Different sections 134-136 may be better aligned with the proximal portion 22a of the left or right foot, depending on the orientation of the main fragment guide 100.

[0063] Referring here to Figures 13A to 13C, once the main segment 22c is moved into alignment by at least one distal K-wire 36, the main segment 22c can be permanently fixed to the implant 52. In particular, as shown in Figure 13A, a drill guide 71 can receive a drill 73 that can be driven through the distal fixation opening 62 and into the main segment 22c of the metatarsal bone 22 to create a hole in the main segment 22c that will receive a bone fixator. The drill guide 71 may be supported by a handle such as the handle 68 described above with respect to Figure 11A. As shown in Figures 13B to 13C, a driver instrument 75 can drive a distal bone fixator 76 through the distal fixation opening 62 and into the hole created in the main segment 22c. In other embodiments, a proximal bone fixator 70 can be driven into the proximal segment 22a without first preparing a hole in the proximal segment 22a.

[0064] The surgical system may include a distal bone fastener 76. The central axis of the fixation opening 62 may extend within the main segment 22c along a trajectory oriented substantially laterally or in any preferred alternative direction. The distal bone fastener 76 may be driven along the central axis of the fixation opening 62, through the distal fixation opening 62, and within the main segment 22c. In one embodiment, the distal bone fastener 76 may be configured as a distal bone screw configured in any manner as described above with respect to the proximal bone fastener 70 (see Figures 11A-11C). Thus, the distal bone fastener 76 may have a threaded shaft 74 that screws into the main segment 22c. Once the distal bone fastener 76 is seated against the implant 52 in the distal fixation opening 62 and the shaft 74 is inserted into the main segment 22c, the implant 52 is attached to and fixed against the main segment 22c for relative movement. Thus, movement of the implant 52 relative to the main segment 22c is prevented. Therefore, it should be understood that the implant 52 is permanently fixed to each of the proximal portion 22a and the main portion 22c so as to prevent movement of the main portion 22c relative to the proximal portion 22a. It should be understood that any number of distal bone fasteners 72 may be driven into the main portion 22c through any number of distal fixation openings 62 of the implant 52, as desired. The head 58 may be positioned relative to the main portion 22c in some embodiments. In other embodiments, a drill or reamer may create a cavity within the main portion 22c that is aligned with the head 58 so that the head 58 can seat in the cavity when the head 58 is fixed to the main portion 22c. Therefore, the head 58 may be recessed relative to the outer surface of the main portion 22c.

[0065] Continuing with reference to Figure 13C, once the main fragment 22c is permanently fixed to the proximal portion 22a in an aligned position, the angle of the proximal phalanx 24 relative to the metatarsal 22 can be adjusted as desired. In particular, the implant 52 may include a loop 78, which may be made from suture, biocompatible metal, or any preferred alternative material. The loop 78 is configured to receive a suture extending through the soft tissue of the foot to create tension that adjusts the angle of the proximal phalanx 24 relative to the metatarsal. The suture can be tied to maintain the desired angle. Adjustment of the angle of the proximal phalanx 24 using a suture as shown in Figures 11A–11E and related descriptions of U.S. Patent Publication No. 2021 / 0038260 (which is incorporated in its entirety by reference).

[0066] As shown in Figure 14, once the implant 52 is permanently fixed to the main fragment 22c, the main fragment guide 100 can be removed from the proximal K-wire 74 and the distal K-wire 36, respectively, the proximal K-wire 74 can be removed from the proximal portion 22a of the metatarsal bone 22, and the distal K-wire 36 can be removed from the main fragment 22c. The incision can then be closed in the usual manner.

[0067] Specific terms The orientation terms used herein, such as “top,” “bottom,” “proximal,” “distal,” “longitudinal,” “lateral,” and “end,” are used in the context of the illustrated embodiments. However, this disclosure should not be limited to the illustrated orientations. In fact, other orientations are possible and within the scope of this disclosure. It should be understood that terms relating to circles, such as diameter or radius, as used herein do not require a perfectly circular structure, but rather should be applied to include any suitable structure having a cross-sectional area that can be measured from the left or right. General shape terms such as “circular,” “cylindrical,” “semicircular,” and “semicylindrical,” or related or similar terms, do not need to strictly adhere to the mathematical definitions of circles, cylinders, or other structures, but can include reasonably approximate structures.

[0068] Conditional language such as “can,” “was able to,” “may be possible,” or “may be able to” is generally intended to convey that a particular embodiment may or may not include a particular feature, element, and / or step, unless otherwise specified or understood in the context in which it is used. Therefore, such conditional language is generally not intended to imply that one or more embodiments require the feature, element, and / or step in any way.

[0069] Unless otherwise specified, connecting language such as “at least one of X, Y, and Z” is understood in the context in which it is commonly used to convey that an item, term, etc., could be any of X, Y, or Z. Therefore, such connecting language is not generally intended to imply that in a particular embodiment, at least one of X, at least one of Y, and at least one of Z must be present.

[0070] As used herein, the terms “approximately,” “about,” and “substantially” refer to a quantity that is close to the stated quantity and still performs the desired function or achieves the desired result. For example, in some embodiments, as the context may indicate, the terms “substantially,” “approximately,” and “about,” as used with respect to dimensions, orientation, shape, or other parameters, may include the stated parameter and differences of up to ±10%, e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% from the stated parameter. As used herein, the term “approximately” refers to a value, quantity, or characteristic that primarily comprises or tends toward a particular value, quantity, or characteristic. For example, in certain embodiments, as the context may indicate, the term “approximately parallel” may refer to something that is less than 20 degrees away from exactly parallel. All ranges include endpoints.

[0071] Several exemplary embodiments of surgical devices and related methods are disclosed. While this disclosure describes specific exemplary embodiments and uses, other embodiments and uses, including embodiments and uses that do not provide all of the features and benefits described herein, are also within the scope of this disclosure. Components, elements, features, actions, or steps may be arranged or performed in ways different from those described, and components, elements, features, actions, or steps may be combined, integrated, added, or excluded in various examples. All possible combinations and subcombinations of the elements and components described herein are intended to be included in this disclosure. A single feature or group of features is not required or essential.

[0072] Certain features described in this disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately or in any suitable subcombination in multiple implementations. Furthermore, while some features are described above as functioning in specific combinations, one or more features from a claimed combination may, in some cases, be excluded from that combination, and the combination may be claimed as a subcombination or a variation of a subcombination.

[0073] Any part of any step, process, structure, and / or apparatus disclosed or illustrated in an example of this disclosure may be combined with (or used in place of) any other part of any step, process, structure, and / or apparatus disclosed or illustrated in a different example or flowchart. The embodiments described herein are not intended to be separate and separable from one another. Several combinations, variations, and implementations of the disclosed functions are within the scope of this disclosure.

[0074] While operations may be shown in drawings or described in the specification in a specific order, such operations do not need to be performed in the specific order or sequence shown, or not all operations need to be performed, in order to achieve the desired result. Other operations not described or described may be incorporated into exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the operations described. Furthermore, in some implementations, operations may be rearranged or rearranged. Also, the separation of various components in the above-described implementations should not be understood as necessary in all implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products. Furthermore, several implementations are within the scope of this disclosure.

[0075] Furthermore, while exemplary embodiments have been described, any embodiments having equivalent elements, modifications, omissions, and / or combinations are also within the scope of this disclosure. Moreover, while certain aspects, advantages, and novel features are described herein, not all such advantages are necessarily achieved according to a particular embodiment. For example, some embodiments within the scope of this disclosure achieve one advantage or group of advantages as taught herein, but do not necessarily achieve other advantages taught or suggested herein. Furthermore, some examples may achieve advantages different from those taught or suggested herein.

[0076] Several embodiments will be described with reference to the drawings. The drawings are drawn and / or shown to scale, but such scale should not be limiting, as dimensions and proportions other than those shown are assumed and within the scope of the disclosed invention. Distances, angles, etc., are for illustrative purposes only and do not necessarily have an exact relationship to the actual dimensions and layout of the illustrated apparatus. Components may be added, deleted, and / or rearranged. Furthermore, certain features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc., relating to various embodiments may be used in all other embodiments described herein. Moreover, any method described herein may be carried out using any apparatus suitable for performing the steps listed.

[0077] For the purpose of summarizing this disclosure, specific aspects, advantages, and features of the invention have been described herein. Not all advantages, or any such advantages, are necessarily achieved in accordance with any particularly specific aspect of the invention disclosed herein. The aspects of this disclosure are not required or essential. In many examples, the apparatus, systems, and methods may be configured in ways different from those shown in the drawings or description herein. For example, the various functions provided by the illustrated modules may be combined, rearranged, added, or removed. In some implementations, additional or different processors or modules may perform some or all of the functions described with reference to the description and illustrated embodiments. Many modifications of the implementations are possible. Features, structures, steps, or processes disclosed herein may be included in any embodiment.

[0078] In short, various embodiments of surgical devices and related methods are disclosed. This disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as specific modifications and their equivalents. Furthermore, this disclosure is expressly intended to allow the various features and aspects of the disclosed embodiments to be combined or substituted with one another. Therefore, the scope of this disclosure should not be limited by the specific disclosed embodiments described above, but should be determined solely by a fair reading of the claims.

[0079] [Implementation Method] (1) A guide configured to adjust a bone having a first part and a second part surgically separated from the first part, wherein the guide is A main body portion defining an inner surface facing the bone and an outer surface opposite to the inner surface, wherein the guide defines a plurality of main body portion openings extending through the main body portion from the outer surface to the inner surface, An alignment portion extending from the main body portion, wherein the alignment portion defines an inner surface facing each bone and an outer surface opposite to each inner surface, and the guide defines a plurality of alignment openings extending through the alignment portion from each outer surface to each inner surface, It comprises a handle portion, the handle portion extending from the main body portion such that the alignment portion and the handle portion extend from both ends of the main body portion, The guide is sized such that at least one of the alignment openings aligns with the first portion, and so at least one of the alignment openings is configured to receive a temporary distal fixation device inserted into the second portion. The guide is sized to align at least one of the body portion openings with the first portion, while at least one of the alignment openings is aligned with the second portion, so that at least one of the body portion openings is configured to receive a temporary proximal fixation device inserted into the first portion. (2) The guide according to Embodiment 1, wherein a pair of the alignment openings are configured to receive each temporary distal fixation device, each inserted into the second portion. (3) The guide according to Embodiment 1, wherein the proximal temporary fixation device and the distal temporary fixation device include a k-wire. (4) The guide according to Embodiment 1, wherein the alignment opening and the main body portion opening extend along their respective central axes which are parallel to each other. (5) The guide according to Embodiment 1, wherein the alignment openings extend along their respective central axes which are parallel to each other, and the body portion openings extend along their respective central axes which are parallel to each other and angularly offset with respect to the alignment openings.

[0080] (6) The guide according to Embodiment 1, wherein the inner surface of the guide portion and the lower surface of the guide portion are flat and parallel to each other. (7) The guide according to Embodiment 1, wherein the alignment portion has height, the guide portion has height, and the height of the alignment portion is greater than the height of the guide portion. (8) The guide according to Embodiment 1, wherein the handle includes a grip section. (9) The guide according to embodiment 8, wherein the grip section extends above the outer surface of the main body portion in a direction from the inner surface toward the outer surface. (10) The guide according to Embodiment 1, wherein the main body openings comprise central sections of main body openings that are aligned with each other along the longitudinal direction, and the aligned openings are aligned in a row that is aligned with the central sections of main body openings.

[0081] (11) The guide according to Embodiment 10, wherein the opening of the main body portion further comprises a first side section of the opening and a second side section of the opening, wherein the first side section of the opening is located between the central section and the first outer side of the main body portion, the second side section of the opening is located between the central section and the second outer side of the main body portion opposite the first outer side along a transverse direction perpendicular to the longitudinal direction, and the inner surface of the main body portion is located opposite the outer surface of the main body portion along a transverse direction perpendicular to the transverse and longitudinal directions, respectively. (12) A surgical system, The guide described in Embodiment 1, A cutting guide configured to receive a cutting instrument for cutting the metatarsal bone so as to separate the second part from the first part, A surgical system comprising: an implant configured to permanently fix a principal fragment to the first portion after the second portion has been repositioned to align with the first portion. (13) A method for adjusting the alignment between a first portion of a bone and a second portion of a metatarsal bone, the method being: The steps include aligning at least one alignment opening of the guide with the second portion of the bone, The steps include, after the alignment step, driving at least one temporary distal fixation member through the at least one alignment opening and into the second portion of the bone, A step of separating the second portion from the first portion by excising the bone so that the second portion defines the separated second portion, wherein the at least one temporary alignment and fixing member extends into the separated second portion. A step of permanently fixing the implant to the first portion, A step of moving the at least one temporary alignment and fixing member relative to the proximal portion so that the separated second portion is moved and repositioned in correspondence with the first portion, The steps include permanently fixing the implant to the separated second portion, A method comprising the step of removing the at least one distal temporary fixation member from the separated second portion after the step of permanent fixation. (14) The method according to Embodiment 13, wherein the alignment step further includes aligning at least one body portion opening with the first portion of the bone, and the driving step includes driving a pair of distal temporary fixation members percutaneously through the corresponding alignment opening and into the second portion. (15) The method of Embodiment 14, further comprising the step of driving a proximal temporary fixation device percutaneously through one of the at least one body openings and into the first portion between the moving step and the second permanent fixation step, thereby positionally fixing the second portion to the first portion.

[0082] (16) The method according to embodiment 15, wherein the removal step further includes removing the proximal temporary fixing member from the first portion. (17) The method according to embodiment 16, wherein the proximal temporary fixing member includes a proximal K wire. (18) The method of Embodiment 14, further comprising the step of placing the guide on the distal temporary fixation member so that the distal fixation member is received in a corresponding alignment opening among the plurality of alignment openings, wherein the moving step includes moving the guide relative to the proximal portion, and the guide is positioned outside the human body including the bone. (19) The method according to embodiment 18, wherein the moving step is to correct the bunion. (20) The method according to Embodiment 13, wherein the first permanent fixation step includes inserting the implant into the pulp canal of the first portion.

Claims

1. A guide configured to adjust a bone having a first portion and a second portion surgically separated from the first portion, wherein the guide is A main body portion defining an inner surface facing the bone and an outer surface opposite to the inner surface, wherein the guide defines a plurality of main body portion openings extending through the main body portion from the outer surface to the inner surface, An alignment portion extending from the main body portion, wherein the alignment portion defines an inner surface facing each bone and an outer surface opposite to each inner surface, and the guide defines a plurality of alignment openings extending through the alignment portion from each outer surface to each inner surface, It comprises a handle portion, the handle portion extending from the main body portion such that the alignment portion and the handle portion extend from both ends of the main body portion, The guide is sized such that at least one of the alignment openings aligns with the second portion, and so at least one of the alignment openings is configured to receive a temporary distal fixation device inserted into the second portion. The guide is sized such that at least one of the main body openings aligns with the first portion while at least one of the alignment openings aligns with the second portion, and so at least one of the main body openings is configured to receive a temporary proximal fixation device inserted into the first portion. A guide in which the main body portion openings comprise central sections of main body portion openings that are aligned with each other along the longitudinal direction, and the aligned openings are aligned in a row that is aligned with the central sections of the main body portion openings.

2. The guide according to claim 1, wherein a pair of the aligned openings are configured to receive each of the temporary distal fixation devices, each inserted into the second portion.

3. The guide according to claim 1, wherein the temporary proximal fixation device and the temporary distal fixation device include a k-wire.

4. The guide according to claim 1, wherein the alignment opening and the main body portion opening extend along their respective central axes which are parallel to each other.

5. The guide according to claim 1, wherein the alignment openings extend along their respective central axes which are parallel to each other, and the main body portion openings extend along their respective central axes which are parallel to each other and angularly offset with respect to the alignment openings.

6. The guide according to claim 1, wherein the inner surface of the main body portion and the outer surface of the main body portion are flat and parallel to each other.

7. The guide according to claim 1, wherein the alignment portion has height, the main body portion has height, and the height of the alignment portion is greater than the height of the main body portion.

8. The guide according to claim 1, wherein the handle portion includes a grip section.

9. The guide according to claim 8, wherein the grip section extends above the outer surface of the main body portion in a direction from the inner surface toward the outer surface.

10. The guide according to claim 1, wherein the main body opening further comprises a first side section of the opening and a second side section of the opening, wherein the first side section of the opening is positioned between the central section of the main body opening and the first outer side of the main body, the second side section of the opening is positioned between the central section of the main body opening and the second outer side of the main body opposite to the first outer side along a transverse direction perpendicular to the longitudinal direction, and the inner surface of the main body is opposite to the outer surface of the main body along a transverse direction perpendicular to the transverse and longitudinal directions, respectively.

11. A surgical system, The guide described in claim 1, A cutting guide configured to receive a cutting instrument for cutting the metatarsal bone so as to separate the second portion from the first portion, A surgical system comprising: an implant configured to permanently fix a principal fragment to the first portion after the second portion has been repositioned to align with the first portion.

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