Joint spacer systems and methods

Abstract

To provide a bone preparation guide.SOLUTION: In some examples, a method for preparing one or more bones involves inserting a spacer into a space defined between a first bone and a second bone, such as a joint space between a first metatarsal and medial cuneiform. A bone preparation guide can be aligned with opposed ends of the first bone and the second bone using the spacer as an alignment reference. For example, the bone preparation guide may include an opening such that the guide can be installed across the joint space with the spacer received in the opening. A clinician may use the bone preparation guide to guide a tissue removing instrument to cut or otherwise prepare the ends of the first bone portion and second bone portion.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 366,219, filed on July 25, 2016, and U.S. Provisional Patent Application No. 62 / 220,530, filed on September 18, 2015. The entire contents of both of these applications are incorporated herein by reference.

[0002] This disclosure generally relates to devices and methods for preparing and realigning bone.

Background Art

[0003] Bones such as the bones of the foot can be anatomically misaligned. In certain situations, surgical intervention is required to correctly align the bones in order to reduce patient discomfort and improve the patient's quality of life.

Summary of the Invention

[0004] This disclosure generally is directed to devices and techniques for preparing one or more bones and realigning them from an anatomically misaligned position to an anatomically aligned position. In some examples, the devices and techniques are utilized to correct a deformity of a plantar fibroma where a first midfoot bone is anatomically misaligned with respect to a medial cuneiform bone and / or a second midfoot bone. To correct such misalignment, a system including a bone preparation guide and a spacer can be utilized. The bone preparation guide can provide one or more cutting surfaces and / or cutting grooves along or through which a cutting instrument can be translated to prepare opposing ends of the first midfoot bone and / or the medial cuneiform bone for relative realignment. The spacer can function as an alignment and / or reference tool for the bone preparation guide.

[0005] In some examples, a clinician inserts a spacer into the joint space between the first midfoot bone and the medial cuneiform bone. The spacer can have a variety of different configurations, such as a central insertion portion, an offset insertion portion, a constant thickness, a tapered thickness, or the like. After the spacer is suitably positioned, the clinician can insert a bone preparation guide across the joint space, for example, by attaching the bone preparation guide over a portion of the spacer that protrudes from the joint space. Next, the clinician can use the bone preparation guide to cut the end of the first midfoot bone and / or the end of the medial cuneiform bone to facilitate realignment of the bones relative to each other. In some examples, the clinician uses tissue removal instrument site verification to confirm the location and / or orientation of one or more cut surfaces or grooves on the bone to be cut before creating such a cut. In any case, the clinician can adjust the position of the first midfoot bone either before or after creating the cut to achieve realignment of the midfoot bone.

[0006] In one example, a method for preparing one or more bones is disclosed. The method includes inserting a spacer into a space defined between a first bone and a second bone. The method further includes aligning a bone preparation guide with a portion of the first bone or the second bone while the spacer is inserted into the space, using the spacer as a reference. Additionally, the method includes using the bone preparation guide to contact a portion of the first bone or the second bone with a tissue removal instrument to direct the tissue removal instrument.

[0007] In another example, a bone preparation guide including a body and a spacer is described. The body has a first guide surface defining a first preparation plane and a second guide surface defining a second preparation plane. The first and second guide surfaces are spaced apart from each other by a certain distance. In this example, a first end extends from the body in a first direction, a second end extends from the body in a second direction, the second direction is different from the first direction, and each of the first end and the second end includes a fixing hole configured to receive a fixing device. This example also specifies that it extends from the body in a third direction, and the third direction is different from the first and second directions. The spacer is configured to be placed within the joint space between opposing bones.

[0008] In another example, a spacer configured to be inserted into the joint spaces between first and second opposing bones is described. The spacer includes a first portion configured to extend within the joint space and a second portion opposite the first portion configured to extend over the joint space. The spacer also includes an intermediate portion disposed between the first portion and the second portion. This example specifies that the spacer is configured to function as a reference for positioning a tissue removal instrument relative to the first and / or second bone.

[0009] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, as well as from the claims.

Brief Description of the Drawings

[0010]

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C - 4F

Figure 4G - 4J

Figure 4K - 4M

Figure 5

Figure 6A

Figure 6B

Figure 6C

Figure 6D

Figure 7

Figure 8

Figure 9

DETAILED DESCRIPTION OF THE INVENTION

[0011] The following detailed description is of a illustrative nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some examples for implementing exemplary embodiments of the invention. Examples of structures, materials, and dimensions are provided for selected elements and all other elements used that are known to those of ordinary skill in the art of the invention. Those of ordinary skill in the art will recognize that many of the described examples have various suitable alternatives.

[0012] Generally, the present disclosure is directed to surgical instruments and techniques that can be used in bone correction procedures. Embodiments of the present disclosure include spacers, bone preparation guides, and / or tissue removal instrument location confirmation members, along with methods of positioning such spacers and guides in medical procedures. Such instruments can be used alone or in combination to improve the effectiveness of bone correction procedures as compared to when procedures without the use of instruments are used.

[0013] In exemplary uses, embodiments of the spacer, bone preparation guide, and / or tissue removal instrument location confirmation member can be used before and / or during surgical procedures such as where one or more bones are prepared (e.g., cartilage or bone removal and / or cutting), bone alignment, osteotomy, fusion procedures, and / or other procedures. Such procedures can be performed, for example, on bones of the foot or hand (e.g., joints or adjacent bones separated by different portions of a single bone) where the bone is relatively small compared to other parts of the human structure. In one example, a procedure utilizing one or more embodiments of the present disclosure can be performed to correct the alignment between the intermediate cuneiform bone (e.g., the first intermediate cuneiform bone) and the second intermediate cuneiform bone and / or the cuneiform bone (e.g., the medial or first cuneiform bone) in, for example, a tenosynovial tumor corrective surgery. An example of such a procedure is the Lapidus procedure (also known as a fusion between the first metatarsal bone and the intermediate cuneiform bone). In another example, the procedure can be performed by modifying the alignment of the intermediate cuneiform bone (e.g., the first intermediate cuneiform bone). An example of such a procedure is a subtalar intermediate cuneiform osteotomy procedure.

[0014] For example, during a calcaneus midfoot (''TMT'') fusion procedure, the described surgical instruments can be combined and used to achieve multi-planar realignment (e.g., two-plane, three-plane) of the first midfoot bone relative to the medial cuneiform bone. A spacer can be used to properly position a bone preparation guide or a cutting guide relative to the TMT joint, and more specifically, to position the guide surface or groove of the cutting guide relative to the bone end to be cut. In some examples, one or more guide surfaces or grooves of the cutting guide are inclined. For example, the cutting guide can be configured to position a guide groove along which a cutting instrument is translated parallel to the end face of the first midfoot bone while another guide groove is refracted relative to the end face of the medial cuneiform bone. The guide groove positioned on the end of the medial cuneiform bone can be inclined proximally from the medial side to the lateral side of the medial cuneiform bone, resulting in the removal of the wedge-shaped section of bone from the medial cuneiform bone. The disclosed instruments can assist in properly preparing the ends of the first midfoot bone and the medial cuneiform bone for repositioning in multiple planes (e.g., frontal plane, cross-sectional plane, and / or sagittal plane), enabling the correction of the first midfoot bone from an anatomically misaligned position to an anatomically aligned position.

[0015] FIG. 1 shows a perspective view of an exemplary bone preparation guide and spacer 10. The bone preparation guide and spacer 10 can include a bone preparation guide 12 and a spacer 14. In some applications, the bone preparation guide and spacer 10 can be provided to facilitate the positioning and / or preparation of a bone or a plurality of bones. In the illustrated example, the bone preparation guide 12 includes a body 16 that defines a first guide surface 18 that defines a first preparation plane and a second guide surface 20 that defines a second preparation plane. A tissue removal instrument (e.g., a saw, a rotary burr, an osteotome, etc., not shown) can be aligned with the guide surface to remove tissue (e.g., remove cartilage or bone, and / or create a cut portion in the bone). The first and second guide surfaces 18, 20 can be spaced apart from each other by a distance (e.g., about 4-7 millimeters, etc., about 2 millimeters to about 10 millimeters). In the illustrated embodiment, the first and second guide surfaces are parallel such that the cut portions for adjacent bones using the guide surfaces are substantially parallel.

[0016] In some embodiments, as shown in FIG. 1, the first opposing surface 22 is positioned adjacent to the first guide surface 18 and / or the second opposing surface 24 is positioned adjacent to the second guide surface 20. In such embodiments, the distance between the first guide surface and the first opposing surface defines the first guide groove 26, and the distance between the second guide surface and the second opposing surface defines the second guide groove 28. Each groove 26, 28 can be sized to receive a tissue removal instrument, which is a tissue removal instrument for preparing a bone end portion therethrough. The first and second grooves 26, 28 may be parallel to each other or may be refracted (e.g., non-parallel). In the illustrated embodiment, the opposing surfaces each contain a gap along their respective lengths such that each surface is not a single continuous surface. In other embodiments, the opposing surfaces can each be a single continuous surface having no such gap.

[0017] In some embodiments, the opening 30 can be defined by the body 16 between the first and second opposing surfaces 22, 24. Thus, as further discussed below, the opening 30 can be, for example, the region between the grooves 26, 28 that is useful for a physician to have a visual path to a bone cutting site (e.g., cartilage, bone, and / or joint space) during bone preparation and / or to allow reception of an instrument. In the illustrated embodiment, the opening 30 extends across the body 16 by the distance from the surface 32 facing the first opposing surface 22 to the surface 34 facing the second opposing surface 24.

[0018] The illustrated embodiment also includes a first end 40 extending from the body 16 in a first direction and a second end 42 extending from the body 16 in a second direction. The second direction may be different from (e.g., opposite to) the first direction. The first and second ends 40, 42 may each extend perpendicularly from the body 16 as shown, and in other embodiments, the first and second ends 40, 42 may extend from the body at different angles. As shown, each of the first end 40 and the second end 42 may include at least one fixing hole 44 configured to receive a fixing device (e.g., a pin, not shown) for fixing the guide 12 to one or more bones. Such holes 44 may be perpendicular to the upper surface of the guide 12 or may extend through each respective end at a refractive angle, as shown.

[0019] The bone preparation guide 12 may also include a first adjustable stabilization member 46 engaged with the first end 40. In some embodiments, the bone preparation guide 12 may also include a second adjustable stabilization member 48 engaged with the second end 42. Each of the members 46, 48 may be threaded and may engage a threaded hole defined by the ends 40, 42. The elevation angle of each end 40, 42 may be adjusted with respect to one or more bones by adjusting the members 46, 48 at the end where elevation adjustment is desired. In some embodiments, as shown, the members 46, 48 may be cannula-shaped so as to be able to receive their respective fixing devices. The bone preparation guide 12 is illustrated as having two adjustable stabilization members, but in other examples, the guide may include fewer adjustable stabilization members (e.g., none, one) or more adjustable stabilization members (e.g., three, four or more), and the present disclosure is not limited in this regard.

[0020] As noted, the bone preparation guide as shown in FIG. 1 includes a spacer 14. The spacer may extend in a third direction from the body, the third direction being different from the first and second directions (e.g., perpendicular to the first and second directions) and may be configured to be placed within the joint space between opposing bones. In some embodiments, the spacer is integral with the guide and the guide and spacer are a single component, e.g., a unibody structure. In other embodiments, the spacer is physically separated from the guide and is insertable into the guide. In these embodiments, the spacer and bone cutting guide may be provided alone or in combination with other components as part of a sterile kit (e.g., packaged within a single common container) to facilitate the performance of the procedure.

[0021] In the illustrated embodiment, the spacer 14 can be selectively engaged with the bone preparation guide 12 such that the spacer and guide can be attached and removed. For example, the spacer 14 can be received by the body 16 of the guide 12 by inserting the spacer into the opening 30 or the like. When the spacer 14 is received within the opening 30, the spacer 14, when provided, can extend between the first guide surface 18 and the second guide surface 20 or within the first and second grooves 26, 28 from the body. In some examples where the spacer 14 is received within the opening 30, there need not be a connection between the guide 12 and the spacer 14 as the opening 30 itself may be sufficient to engage the guide and spacer. The spacer 14 can engage the guide 12 such that the guide 12 and / or the spacer 14 are movable relative to each other in the engaged state (e.g., in the vertical direction). For example, in some embodiments, the guide 12 is movable relative to the spacer 14 while the spacer is engaged within the joint space such that the guide can be inserted onto or removed from the spacer while the guide 12 and the pacer 14 are engaged. For example, the distal portion of the spacer can be inserted into the guide 12 positioned on top of the upper portion of the spacer while the proximal portion of the spacer projects from the top of the guide and the joint space (e.g., the joint space between the calcaneus and the midfoot) is present. In yet further embodiments, the guide 12 and the spacer 14 can be removably attachable by magnets, snap fits, male-female joints, or other temporary connections or the like.

[0022] Figures 2A and 2B show embodiments of the spacer 14. In some embodiments, the spacer 14 is configured to be used to guide a bone preparation instrument during a surgical procedure. In other embodiments, the spacer 14 is configured to be inserted into a bone preparation guide. FIG. 2A illustrates a perspective view of the spacer 14, and FIG. 2B illustrates the spacer 14 on a foot. The spacer 14 can be configured to be inserted into the space between two bones 50 and 52 (e.g., a joint between a single bone or adjacent bones separated by different parts), whether it is a self - standing component, a separate component selectively engageable with a guide, or a separate component integrated with a guide.

[0023] In one use, the space between the two bones into which the spacer 14 is configured to be inserted can be a TMT joint space, such as the joint between the first mid - foot bone and the cuneiform bone as shown in FIG. 2B where bone 50 is the first mid - foot bone and bone 52 is the medial cuneiform bone. The spacer 14 can be inserted into the space between the two bones in a variety of different directions depending on the use. In one example, the spacer 14 is inserted from the substantially dorsal side of the foot. In another example, the spacer 14 is inserted from the substantially dorsomedial side of the foot or the medial surface of the foot.

[0024] As seen in the embodiment of FIG. 2A, the spacer 14 can include a first portion 60 configured to at least partially extend into the space between two bones (e.g., the joint space between bones 50 and 52 as shown in FIG. 2B). In the embodiment shown in FIG. 2A, the first portion 60 is a substantially flat member having opposing flat surfaces. In other embodiments, the substantially flat member has one or more grooves and / or holes. In still other embodiments, the first portion has at least two extending members configured to extend into the joint space. The extending members can include any cross - sectional shape, such as cylindrical, triangular, or frustoconical shapes.

[0025] As shown in FIG. 2A, the first portion 60 may include a keel 62, which is configured to facilitate insertion into the space between two bones at the end of the first portion 60. As shown, the tip of the keel 62 is linear (e.g., extending in a plane parallel to the width of the keel). In other embodiments, the tip of the keel 62 may be circular and / or tapered to provide easier insertion into the space between the two bones of the keel 62. In some embodiments, the keel 62 may have a width that is less than or equal to the width of the space between two bones (e.g., the width of the joint). Additionally, the keel 62 may have a thickness (e.g., extending in a direction perpendicular to the width of the keel and along the length of the space between the two bones) that is less than or equal to the length of the space between the two bones. In some applications, it may be desirable to configure the thickness of the keel 62 to be thicker relative to the length of the space between the two bones so that the keel 62 fits snugly within the space between the two bones. For example, the thickness of the keel 62 may be sized to modify the space between the two bones, such as by expansion, when inserted. The keel 62 may have a uniform thickness along its length as seen in FIG. 2A, or may have a varying thickness, such as a thickness that tapers in the direction of travel towards the tip of the keel 62 (e.g., a wedge-shaped keel).

[0026] The length of the keel 62 and the first portion 60 can be configured to allow the keel 62 to extend perpendicular to the bottom base between two bones (e.g., when the spacer 14 is used in an on-foot application as seen in FIG. 2B, the keel 62 can extend from the substantially dorsal side of the foot to the substantially flat side). In other examples, the length of the keel 62 can be configured such that the keel 62 only partially extends into the space between two bones, such as through a point within the space between two bones where opposing joint surfaces (e.g., the flat joint surfaces of two bones) exist, and stops extending into the space between two bones where a protrusion or eccentric joint surface exists. The keel 62 as shown in the illustrated example is substantially linear along its length. However, in other examples, the keel 62 can include one or more contours along its length, and the one or more contours are configured to match the anatomical geometry of one or more bone ends that join in the space into which the keel 62 is inserted.

[0027] The keel 62 and the first portion 60 can be made from a variety of materials suitable for one or more desired uses of the spacer. In one example, the keel can be made from a rigid material such as metal or plastic that does not deform or otherwise change shape when inserted into the space between two bones. By preventing the keel from deforming when inserted into the space between two bones, the spacer can be maintained in a state substantially aligned with the bone surfaces joined in the space. In other examples, the keel can be made from a flexible material to provide some flexibility in its shape while substantially maintaining the alignment of the spacer with the bone surfaces joined in the space to conform to one or more non-parallel portions of the bones joined in the space. In other embodiments, the keel includes a combination of a rigid material and a flexible material. For example, the perimeter of the keel can include a flexible material to facilitate insertion into the joint space, and the central portion can include a rigid material to prevent deformation.

[0028] The spacer 14 may further include a second portion 64 at or near an end of the spacer 14 opposite the keel 62. The second portion 64 may be designed to be grasped by the hand of a surgeon during the procedure, etc. In some examples, the second portion 64 may have one or more recesses 66 (two recesses 66 are shown in FIG. 2A, and each recess 66 is disposed on the opposite side of the other) to improve grasping on the second portion 64. In some embodiments, the second portion 64 may also include a roughened texture also to improve grasping on the second portion 64. The one or more recesses 66 and / or the roughened texture may be particularly beneficial when the second portion 64 is grasped by the surgeon's wet and / or gloved hand.

[0029] In some embodiments, the spacer 14 may have an intermediate portion 68 disposed between the first and second portions 60, 64. The first, second, and intermediate portions may be provided as an integral member or as separately joined components. In either case, each portion may include a different material than the other portions, and the material may have different characteristics than the materials of the other portions, such as rigidity and flexibility. Alternatively, all portions of the spacer 14 may be manufactured from the same material, such as a single body formed from metal or plastic.

[0030] In embodiments provided as a separate component from the bone preparation guide and configured to engage with the bone preparation guide, the intermediate portion 68 may be engagable with the body of the guide (e.g., in an opening defined by the body of the guide). In the example shown, the intermediate portion 68 may have a first region 70 and a second region 72. The first region 70 may have a thickness extended with respect to the thickness of the first portion 60 (and thus the keel 62) and may translate along its length from the junction with the guide to the second portion 64. The second region 72 may have a width extended with respect to the width of the first portion 60 (and thus the keel 62). The extended thickness of the first region and / or the extended width of the second region 72 may enable the body of the guide to more stably receive the spacer 14 in an example where the spacer 14 and the guide are separate components.

[0031] In embodiments configured such that the spacer 14 is used as a self - standing device without a bone guide, the intermediate portion 68 can be used to provide a first guide surface and an opposing second guide surface. In such embodiments, the first portion 60 (and thus the keel 62) of the spacer can be inserted into the joint space and the surface of the intermediate portion 68 can be used to provide the guide surface. For example, the surface of the first region 70 on the first side of the spacer 14 can be configured as the first guide surface, and the first region 70 on the opposing side of the spacer 14 can be configured as the second guide surface. In some embodiments, at least the first region 70 of the intermediate portion 68 has a thickness greater than the thickness of the first portion 60. The difference in thickness between the first region 70 and the first portion 60 on each side of the spacer 14 can define the length and thickness of the tissue removed by the tissue removal instrument guided by the surface of the intermediate portion.

[0032] In use, the first portion 60 can be placed within the joint space and tissue removal instrument that is positioned relative to the intermediate portion 68 so as to guide the preparation of the first bone on the first side of the spacer 14. The tissue removal instrument can be positioned relative to the intermediate portion 68 so as to guide the second preparation on the second opposing side of the spacer 14 to the second bone. In certain examples, the tissue removal instrument can be guided by the spacer 14 for approximately one half of the thickness of the tissue to be removed. Next, the spacer can be removed from the joint space and the tissue removal instrument reinserted to complete tissue removal.

[0033] Figures 3A and 3B show perspective and side views, respectively, of the bone preparation guide and spacer 10 on the foot. Depending on the embodiment, the bone preparation guide and spacer 10 can be positioned on the foot in different ways. In embodiments where the spacer 14 is a separate component from the guide and is configured to engage with the guide, the spacer 14 can first be inserted into the space between two bones (such as shown in Figure 2B). In such embodiments, after the spacer 14 is properly inserted into the space between two bones, the guide 12 can then be placed on the foot so as to engage the already inserted spacer 14 (for example, by sliding the guide 12 vertically downward toward the foot on the spacer 14 through an opening defined by the body of the guide 12, etc.). Alternatively, the guide 12 can first be positioned adjacent to the space between two bones, and then the spacer 14 can be inserted through the guide into the joint space underlying the guide. The guide 12 can pre-position the spacer 14 (for example, through an opening defined by the body of the guide 12) into the space between two bones. After pre-positioning, the clinician can manipulate the location of the guide 12 and / or the spacer 14 to orient them to the desired location with respect to the two bones (for example, by orienting the cutting groove of the guide 12 with respect to the ends of the bones 50 and 52, respectively). In other embodiments (for example, where the spacer 14 and the guide 12 are integral or separate components), the bone preparation guide and spacer 10 can be positioned on the foot with the guide 12 positioned as a single structure within the joint between two bones, for example, thereby positioning the guide 12 and the spacer 14 on the foot simultaneously.

[0034] Apart from the method in which the spacer 14 is inserted into the joint between the bones 50, 52 with respect to the attachment of the guide 12 on the bone, the spacer 14 can serve the function of providing initial stability with respect to the guide 12 (for example, before the guide 12 receives the fixing device). For example, the spacer 14 can engage with the guide 12 and, once seated within the interosseous space, serve the function of supporting the guide 12. Further, when the guide 12 and the spacer 14 are separate components that can be inserted into each other, the depth to which the spacer 14 is inserted into the interosseous space can be adjusted without the need to remove the guide 12. Similarly, the distance at which the guide 12 is positioned perpendicular to the interosseous space can be adjusted while leaving the spacer 14 in place.

[0035] During operation, the spacer 14 can function as an alignment and / or reference tool with respect to the guide 12 for one or more bone surfaces that are prepared (for example, cut, fragmented). Such surfaces to be prepared can include all or a portion of the joint surface of the bone 50 or 52 as shown. When the spacer 14 is inserted into the space (for example, joint) between the bones 50, 52, the spacer 14 can serve the function of aligning the guide 12 at an appropriate position (for example, longitudinally along the bones 50, 52) and orientation (for example, an angle with respect to the bones 50, 52 in a plurality of planes selected from more than one of the frontal, transverse, and sagittal planes) with respect to the intended procedure for the prepared surfaces of the bones 50, 52.

[0036] For example, when the spacer 14 is inserted into the space between the bones 50, 52, the spacer can assist in the alignment and orientation of the first guide surface 18 and the second guide surface 20 (and / or the grooves 26, 28 when provided) of the guide 12 with respect to the respective surfaces of the bones 50, 52 to be prepared in one or more planes. When inserted into the space between the bones 50, 52, the spacer 14 can engage the guide 12 (e.g., physically limit the free range of movement of the guide 12) and can align the guide 12 longitudinally with each of the surfaces of the bones 50 and 52 to be prepared. For example, the spacer 14 can align the first guide surface 18 longitudinally with the second guide surface 20 having the end surface of the bone 52 and the end surface of the bone 50. In addition, when inserted into the space between the bones, the spacer 14 can extend out of the space and can provide an indication regarding the location of the respective joint end surfaces of the bones 50 and 52. Thus, the orientation of the guide 12 with respect to the spacer 14 functions as an angular reference with respect to the end surfaces of the bones 50 and 52. Accordingly, the spacer 14 can facilitate the accurate preparation of the desired surfaces of one or more bones 50, 52.

[0037] In some applications, it may be desirable to prepare one or both of the bones 50, 52 by cutting a wafer, which is a thin piece having a substantially constant thickness, from one or both surfaces. In such applications, the spacer 14 can be configured to orient the first guide surface 18 that is parallel to the preparation surface of the bone 52 and / or the second guide surface 20 that is parallel to the preparation surface of the bone 50. In the case of a joint between a midfoot bone and a cuneiform bone as shown in FIG. 3A where the joint bone end surfaces are relatively flat, using the spacer 14 as a reference to orient the first guide surface 18 and the second guide surface 20, or the grooves 26, 28 when provided, that are parallel to the bone end surfaces to be cut can facilitate the removal of a wafer of relatively constant thickness. Depending on the procedure being performed, the end of the bone 50 facing the bone 52 and / or the end of the bone 52 facing the bone 50 can be fragmented in addition to or instead of being cut to prepare the end of the bone.

[0038] In other additional or alternative uses, it may be desirable to prepare the joint surfaces of one or both of the bones 50, 52 by cutting a wedge-shaped portion from the joint surfaces of one or both of the bones 50, 52 that do not have a uniform thickness (e.g., laterally from the inside of the cut). For example, in one use, the bottom-based wedge may be cut from the medial cuneiform bone (e.g., bone 52) to correct, for example, a misaligned first metatarsal bone (e.g., bone 50). When the first guide surface 18 and the second guide surface 20, or the grooves 26 and 28 are provided to cut the wedge-shaped portion from the joint end surfaces of one or both of the bones 50, 52, they can be used with respect to the spacer 14 as a reference for the bending angle at which one or more of the bones 50, 52 are cut and can be oriented at the bending angle with respect to each of the bones 52 and / or 50. For example, the first guide surface 18 and / or the second guide surface 20 may slope proximally backward along the length of the medial cuneiform bone because the guide surface extends from the inner side portion of the medial cuneiform bone to the lateral side portion of the medial cuneiform bone. As a result, cutting of the bone portion using a guide surface configured in this way can remove more bone from the lateral side portion of the medial cuneiform bone than from the inner side portion of the medial cuneiform bone, resulting in the wedge-shaped portion of the bone being removed from the medial cuneiform bone.

[0039] In addition to functioning as a reference for positioning and orientation in bone preparation, the spacer 14 can also function as a reference for indicating the thickness of tissue (e.g., bone, etc.) removed from the surfaces of the bones 50 and / or 52. For example, the distance between the first longitudinal surface of the spacer 14 and the first guide surface 18 can define the thickness of the tissue cut from the surface of the bone 52. Similarly, the distance between the second longitudinal surface of the spacer 14 (e.g., opposite the first longitudinal surface) and the second guide surface 20 can define the thickness of the tissue cut from the surface of the bone 50. Thus, the clinician can use the spacer 14 as a reference to visualize whether the proposed bone preparation, such as whether the thickness of the cut to be made conforms to the desired thickness of the tissue to be removed, before preparing one or more bones and can make any adjustments before performing the bone preparation operation.

[0040] In some embodiments, the guide may be specified by an identification number representing the cutting thickness facilitated by that particular guide, defined by the distance between the adjacent surface of the spacer 14 and each guide surface of the guide. In one embodiment, the distance between the first guide surface 18 and the spacer 14 may be different from the distance between the second guide surface 20 and the spacer 14 so as to be able to perform cuts of different thicknesses on different articular bones. In some examples, the distance between one or more guide surfaces on the guide and the spacer 14 may be adjustable, allowing the user to change the thickness of the material removed by the cut.

[0041] In applications where the cutting guide 12 includes a guide surface (e.g., the first guide surface 18 and / or the second guide surface 20) that slopes proximally from the inner side of the foot to the lateral side where the cutting guide is applied, the angle of the slope may be fixed or variable. For example, the cutting guide 12 may have an adjustable guide surface (e.g., the first guide surface 18 and / or the second guide surface 20) that can adjust the angle of the slope. In fact, the clinician can set the angle of the guide surface(s) relative to the bone so that, for example, depending on the set angle, more is removed on the lateral side than on the inner side, more is removed on the inner side than on the lateral side, or the same amount is removed on both the lateral side and the inner side. In some configurations, the adjustable angle may be temporarily fixed or locked to prevent unauthorized movement after setting the desired angle. Depending on the design, the guide surface (e.g., the first guide surface 18 and / or the second guide surface 20) may be adjustable to provide an angle in the range of 0 degrees to 25 degrees, such as 0 degrees to 10 degrees (e.g., between the guide surface and the first and / or second opposing surfaces 22, 24). For example, the guide surface may be adjustable to a non-zero angle less than 25 degrees.

[0042] Although the spacer 14 is shown as being engagable with the guide 12, the spacer 14 can also be configured to engage other guides. For example, the spacer 14 can be used as part of a kit that includes a plurality of guides having different cutting widths. A clinician can select one of the plurality of differently sized guides and use the selected guide in combination with the spacer for performing the procedure. For example, a clinician can select one guide 12 that engages the spacer 14 and that can provide a specified first cutting thickness. If the clinician determines, based on the spacer 14, that the cutting thickness that would result from using the first guide is not desirable for a particular operation, the spacer 14 can be removed from the first guide and engaged with a second guide having a specified second cutting thickness that is different from the first cutting thickness of the first guide.

[0043] The spacer 14 illustrated and described above with respect to FIGS. 1 - 3 can provide an effective tool for performing various medical procedures, such as assisting in the positioning of a bone preparation guide during a fusion procedure between the calcaneus and midfoot bones. However, the configuration of the spacer 14 can vary, for example, according to the characteristics of use and the target clinical outcome.

[0044] As an example, the width of the spacer 14 can be sized such that when the spacer is positioned between bones, it extends within the lateral region of the adjacent bone ends. For example, the width of a portion of the spacer 14 configured to be positioned between adjacent portions of a bone (e.g., the first portion 60) can be wide enough (laterally from the inside) to extend within at least the lateral half of the end face of the adjacent bone where the spacer is positioned.

[0045] For example, when the spacer 14 is configured to be inserted within a joint space between the calcaneus and the midfoot bone (e.g., between the first midfoot bone 50 and the medial cuneiform bone 52), the first portion 60 of the spacer may project laterally by a distance sufficient to position the first portion of the spacer between the lateral halves of the end faces of the first midfoot bone 50 and the medial cuneiform bone 52. The first portion 60 may contact the ends of the first midfoot bone 50 and the medial cuneiform bone 52 on the lateral sides of the bone ends (e.g., the most lateral half, the most lateral third, the most lateral edge). In some configurations, when the first portion 60 of the spacer 14 is positioned between the first midfoot bone 50 and the medial cuneiform bone 52, it may extend laterally by a distance sufficient to contact the inner side of an adjacent bone (e.g., the second midfoot bone).

[0046] In a configuration where the spacer 14 is symmetric, the first portion 60 of the spacer may also project inwardly to contact the ends of the first midfoot bone 50 and the medial cuneiform bone 52 on the inner sides of the bone ends (e.g., the innermost half, the innermost third, the innermost edge). Alternatively, as will be considered in more detail below, the first portion 60 may be laterally offset in the dimension between the inner and lateral directions. In either case, the second portion 64 may be symmetric with respect to the first portion and may have the same width as the first portion, or may be symmetric with respect to the first portion and / or may have a different width than the first portion.

[0047] Configuring the spacer 14 to have a portion that can be positioned within the lateral portion of the joint space can be useful in helping to prevent misalignment of the guide 12. In fact, when the bone 50 is realigned relative to the bone 52 and / or an adjacent bone (e.g., the second metatarsal bone), the gap between the bone 50 and the bone 52 may open on the inner side portion of the joint space between the ends of the bones. This gap can occur, for example, when the angle between the first metatarsal bone and the second metatarsal bone is closed by pivoting and / or rotating the first metatarsal bone towards the second metatarsal bone. In some situations, when a gap on the inner side portion of the joint space is open, a spacer positioned on the side of the joint space can shift (e.g., laterally or medially) and / or rotate (e.g., such that a portion of the spacer on the joint space does not project dorsally, but instead projects in a direction between the lateral dorsal or medial and dorsal). When the guide 12 is then positioned on the shifted and / or rotated spacer 14, the cutting surface(s) of the guide can be misaligned relative to the ends of the bones 50 and 52 when the desired cut is made.

[0048] By configuring the spacer 14 such that at least a portion of the spacer positioned between the ends of the bones 50 and 52 (e.g., within the joint space between the calcaneus and the midfoot bone) is on the lateral side of the joint space, the spacer can maintain a properly positioned state through realignment of the bone 50. For example, when the intermetatarsal angle between the first metatarsal bone and the second metatarsal bone is closed by pivoting and / or rotating the first metatarsal bone towards the second metatarsal bone, the lateral sides of the ends of the bones 50 and 52 can move towards each other, while the inner sides of the ends of the bones can move away from each other. Thereby, the lateral portion of the spacer 14 between the ends of the bones can be pinched (e.g., by pressing the lateral sides of the ends of the bones against the opposing sides of the spacer). As a result, when the guide 12 is subsequently positioned on the spacer 14, the guide can be held in a stable position within the interosseous joint space such that the guide is properly positioned relative to the cut ends of the bones 50 and 52 (e.g., by translating a cutting instrument along and / or through the guide surface of the guide to excise the bone ends).

[0049] The spacer 14 can have a variety of different configurations that allow at least a portion of the spacer to be positioned on the lateral side of the end face of the bone into which the spacer is inserted. As another example, a portion of the spacer 14 configured to protrude from the bottom side of the bone preparation guide 12 (e.g., the portion positioned within the joint space between the opposing ends of the bones 50 and 52 while the guide 12 is positioned on top of the bone) can be disposed on the side of the guide 12 and / or can be symmetric with respect to the portion of the spacer that protrudes from the top of the guide (e.g., on the dorsal side of the guide). For example, instead of configuring the first portion 60 of the spacer 14 to be positioned substantially centrally within the joint between the ends of the bones 50 and 52, the first portion 60 of the spacer can be offset with respect to the geometric center of the ends of the bones and the axis extending through the joint therebetween. When configured in such a manner, the spacer 14 can be inserted into one side of the joint space between the bones 50 and 52 while leaving the other side of the joint space without any spacer substrate.

[0050] As an example of this configuration, the spacer 14 can be configured to be offset with respect to an axis along which the first portion 60 extends through the geometric center of the second portion 64. For example, when the second portion is configured to have a guide 12 that can be inserted within and removed above the upper portion of the second portion 64, the first portion 60 can project downwardly from one side of the second portion. In use, such a configuration can project the first portion 60 symmetrically with respect to a cross-sectional plane (e.g., an inner lateral plane at a single elevation angle) with respect to the second portion 64 and / or can position the guide 12 on the guide.

[0051] For example, when the spacer 14 is configured to be inserted within a joint space between the calcaneus and the midfoot (e.g., between the first metatarsal and the medial cuneiform), the first portion 60 of the spacer can be offset laterally with respect to the second portion 64. That is, the first portion 60 can be preferentially positioned toward the lateral side of the joint such that it faces the inner side of the joint. The laterally offset first portion 60 of the spacer 14 can contact the ends of the bones 50 and 52 that are on the lateral side (e.g., the most lateral half, the most lateral third, the most lateral edge) of the bone ends but not on the inner side (e.g., the innermost half, the innermost third, the innermost edge) of the bone ends. The second portion 64 of the spacer can be substantially centered between the lateral and inner edges of the bones 50 and 52. Thus, the portion of the spacer 14 that is visible to the clinician and / or used to orient the guide 12 (e.g., by positioning the guide on the spacer) can be substantially centered laterally inwardly on the ends of the bones 50 and 52. However, the portion of the spacer 14 that actually projects beneath the dorsal surfaces of the bones 50 and 52 in the bottom side direction can be offset laterally inwardly with respect to the lateral side.

[0052] Figures 4A and 4B illustrate an exemplary configuration of a spacer 400 having a laterally offset structure that can be positioned within a joint space. FIG. 4A illustrates a perspective view of the spacer 400, and FIG. 4B illustrates a perspective view of the spacer 400 on the foot. Like reference numerals used with respect to the spacer 400 refer to like elements discussed above with respect to the spacer 14. The spacer 400 can be configured to be inserted within the space between two bones 50 and 52 (e.g., adjacent bones separated by a joint, or different portions of a single bone), whether it is selectively engagable with a guide or is a separate component integrated with the guide. In one application, the space between two bones configured to receive the spacer 400 can be a joint space of the tarsometatarsal (「TMT」), such as the joint between a first midfoot bone and a cuneiform bone as shown in FIG. 4B.

[0053] As shown in the example of FIG. 4A, the spacer 400 includes a first portion 60 configured to at least partially extend within the space between two bones (e.g., the joint space between bones 50 and 52 as shown in FIG. 4B). The first portion 60 defines a central longitudinal axis 402. The first portion 60 further includes a first sidewall 404 and a second sidewall 406 that define the width of the first portion 60 therebetween. The first portion 60 can include a keel 62 that is configured to facilitate insertion of the first portion 60 into the space between the two bones at the end. In one example, the thickness of the keel 62 is tapered and can move in a direction towards the tip of the first portion 60 (e.g., towards the top of the keel 62). In some cases, the keel 62 can extend perpendicular to the bottom base of the space between the two bones, and in other cases, the keel 62 can extend only partially within the space between the two bones. Regardless of whether the thickness of the first portion 60 (including the keel 62) is constant or varies over the length of the first portion, in some examples, the thickness is in the range of 0.2 mm to 3 mm, such as 0.38 mm to 1.8 mm.

[0054] The spacer 400 illustrated in FIGS. 4A and 4B further includes an end of the spacer 400 facing the keel 62 or an adjacent second portion 64. As seen in FIG. 4A, the second portion 64 has a central longitudinal axis 408. The second portion 64 may be designed to be gripped by the hand of the surgeon during the procedure or the like. In some examples, the second portion 64 may have one or more recesses 66 and / or a roughened texture to improve gripping on the second portion 64.

[0055] In some embodiments, the spacer 400 may also have an intermediate portion 68 disposed between the first and second portions 62, 64. In embodiments where the spacer 400 is provided as a separate component from the bone preparation guide and is configured to engage with the bone preparation guide, the intermediate portion 68 may be engagable with the body of the guide (e.g., in an opening defined by the body of the guide). In the example shown, the intermediate portion 68 has a first region 70 and a second region 72. The first region 70 may have a thickness extended with respect to the thickness of the first portion 60 (and thus the keel 62) and may translate along its length from the junction with the guide to the second portion 64. The second region 72 may have a width extended with respect to the width of the first portion 60 (and thus the keel 62). In the example shown, the intermediate portion 68 including the first and second regions 70, 72 has a central longitudinal axis that coincides with (e.g., is coaxial with) the central longitudinal axis 408 of the second portion 64.

[0056] As shown in FIGS. 4A and 4B, the illustrated embodiment of the spacer 400 has a substantially offset configuration. In some examples, the offset configuration of the spacer 400 includes a first portion 60 that is offset from a second portion 64 and / or an intermediate portion 68. In the illustrated embodiment where the second portion 64 and the intermediate portion 68 have a common central longitudinal axis 408, the first portion 60 is offset from both the second portion 64 and the intermediate portion 68. Specifically, the central longitudinal axis 402 of the first portion 60 is spaced apart from the central longitudinal axis 408 of the second portion 64 and the intermediate portion 68. Although the specific dimensions can vary depending on the desired application, in some configurations, the distance separating the geometric entry of the central longitudinal axis 402 of the first portion 60 from the geometric center of the central longitudinal axis 408 of the second portion is in the range of 1 mm to 20 mm, such as 3 mm to 17 mm. The width of the first portion 60 (from the first sidewall 404 to the second sidewall 406) can also vary, but in some examples, the width is in the range of 2 mm to 25 mm, such as 5 mm to 20 mm. Thus, in some configurations, the distance from the geometric center of the central longitudinal axis 408 bounding the most lateral extent of the spacer 14 to the first sidewall 404 can be in the range of 5 mm to 15.

[0057] As shown in FIG. 4B, the spacer 400 can be inserted into the space between two bones 50 and 52. When inserted, the offset configuration of the spacer 400 can result in a first portion 60 that contacts the bones 50 and 52 (e.g., the end faces of the bones), and optionally, an adjacent third bone 53 (e.g., the inner side portion of the bone), and the second portion 64 and its central longitudinal axis 408 are positioned substantially at the center of the joint. In the illustrative example of FIG. 4B, the spacer 400 is inserted into a first TMT joint, and the first portion 60 is in contact with the first metatarsal 50, the first cuneiform 52, and the second metatarsal 53. For example, the first face surface of the first portion 60 can contact the first metatarsal 50, the second face surface of the first portion 60 that faces the first face surface can contact the first cuneiform 52, and the first side wall 404 of the first portion 60 can contact the inner side portion of the second metatarsal 53. Thus, the central longitudinal axis 408 of the second portion 64 can be positioned substantially centrally between the inner side portion and the lateral side portion of the TMT joint, but the central longitudinal axis 402 of the first portion 60 may be substantially closer to the lateral side portion than the inner side portion of the TMT joint (e.g., to the lateral third of the TMT joint). Thus, in some examples, the first portion 60 can be inserted and fixed only within the lateral region of the TMT joint.

[0058] The offset configuration of the spacer 400 can be useful, for example, in providing a stable spacer within the joint space during a procedure in which bone alignment is modified. For example, in one type of bone alignment procedure, the bone 50 may need to be realigned (e.g., using the positioning device 410) in a way that reduces the angle between the bone 50 and the bone 53. While the bone 50 is in the realigned state, the gap at the inner side portion of the joint between the bone 50 and the bone 52 can increase. This can cause the spacer positioned within the joint to be unstable (e.g., because the spacer is no longer firmly engaged between the bones 50 and 52 due to the increased gap at the inner side portion of the joint).

[0059] Using a spacer 400 having an offset structure within the joint during bone realignment can help to stably maintain the spacer 400 within the joint. For example, since the spacer 400 may have a first portion 60 positioned within the joint closer to the lateral side than the medial side (e.g., in the lateral region of the joint such that the first sidewall 404 contacts the medial side of the second metatarsal 53), the spacer can be substantially maintained in a fixed position within the joint during this realignment. This can result because the separation between the bones 50 and 52 at the lateral side of the joint during realignment can remain substantially constant or can be reduced relative to the separation prior to realignment. As a result, the first portion 60 positioned in the lateral region can be stably retained within the joint even after this realignment is complete. Further, since the first portion 60 is stably maintained within the joint, the second portion 64 and its central longitudinal axis 408 can also be substantially maintained in their original positions, such as at the center of the joint. Next, this configuration of the spacer 400, which can provide increased stability, can be beneficial when the spacer 400 is utilized to facilitate the preparation (e.g., cutting) of one or more bone surfaces, as described below with reference to FIG. 5.

[0060] Regardless of whether the spacer is configured to have a first portion aligned with the second portion (as considered with respect to spacer 14, for example) or a first portion offset with respect to the second portion (as considered with respect to spacer 400, for example), the spacer can have a variety of different cross-sectional configurations. For example, while the spacers 14 of FIGS. 1 - 3 and the spacers 400 of FIGS. 4A and 4B are illustrated as having a constant thickness across the width of the spacer, the thickness of the spacer can vary across the width.

[0061] Figures 4C - 4F illustrate an exemplary configuration of spacer 14 in which the thickness of the spacer varies across the width of the spacer. FIG. 4C is a plan view of the exemplary spacer, FIG. 4D is a front view of the spacer, and FIGS. 4E and 4F are opposing side views of the spacer. The Z - axis in the figures represents the vertical orientation of the spacer (e.g., back - to - bottom direction) in typical use. As shown in the illustrated example, spacer 14 defines a length L (e.g., parallel to the longest axis of the spacer), a width W perpendicular to the length, and a thickness T perpendicular to both the length and the width. The width W of the first portion 60 is the distance from the first side wall 15 to the second side wall 17 of the first portion. In the illustrated configuration, the thickness T of the spacer is tapered across the width of the spacer from the first side wall 15 to the second side wall 17.

[0062] Figures 4G - 4J similarly illustrate an exemplary configuration of spacer 400 in which the thickness of the spacer varies across the width of the spacer. FIG. 4G is a plan view of the exemplary spacer, FIG. 4H is a front view of the spacer, and FIGS. 4E and 4F are opposing side views of the spacer. Again, the Z - axis in the figures represents the vertical orientation of the spacer (e.g., back - to - bottom direction) in typical use. As shown in the illustrated example, spacer 14 defines a length L (e.g., parallel to the longest axis of the spacer), a width W perpendicular to the length, and a thickness T perpendicular to both the length and the width. The width W of the first portion 60 is the distance from the first side wall 404 to the second side wall 406 of the first portion. In the illustrated configuration, the thickness T of the spacer is tapered across the width of the spacer from the first side wall 404 to the second side wall 406.

[0063] When configured to have different thicknesses across its width, the spacer 14 (Figs. 4C - 4F) / spacer 400 (Figs. 4G - 4J) is thicker on one sidewall than on the other. In different examples, the spacer may have a continuous angle of a tapered portion across its width W, such as one or more steps defining translational points of different thicknesses, or a discontinuous tapered portion. In some examples, the spacer has a thickness of at least less than 0.1 mm on its thinner sidewall compared to its thicker sidewall, such as at least less than 0.2 mm, at least less than 0.5 mm, or at least less than 1 mm. For example, the spacer has a thickness of 0.1 mm to less than 2 mm on its thinner sidewall compared to its thicker sidewall. Additionally, although the second portion 64 and the intermediate portion 68 of the spacer 14 / 400 are shown as non - tapered, in other embodiments, one or both of the second portion 64 and the intermediate portion 68 may be tapered.

[0064] In use, a spacer having a tapered thickness can be positioned within a TMT joint with the thicker side of the TMT joint spacer positioned inwardly and the thinner side of the spacer positioned laterally across the joint. During realignment of the first metatarsal bone relative to the medial cuneiform bone, a larger gap may open on the medial sidewall between the end face of the first metatarsal bone and the end face of the medial cuneiform bone than on the lateral sidewall. Thus, positioning the thicker portion of the spacer inwardly and the thinner portion of the spacer laterally across the TMT joint can help fill the inter - bone gap, for example, fit snugly within the TMT joint space and help prevent improper movement of the spacer.

[0065] The spacer 14 / 400 can have any suitable cross-sectional shape. For example, although the spacer 14 / 400 is illustrated as defining a substantially rectangular shape, in other examples, the spacer can define other shapes. The spacer 14 / 400 can define any polygon (e.g., quadrilateral, hexagon) or arcuate (e.g., circular, elliptical) shape, or even a combination of polygon and arcuate shapes. In fact, the first portion 60 of the spacer 14 / 400 need not be a continuous configuration over its width W, but can be formed from discontinuous segments or portions of material that together achieve the function of the spacer.

[0066] FIG. 4K illustrates an exemplary configuration of a spacer 400 formed by at least two pins 403A and 403B that are separated from each other and have a gap therebetween in the first portion 60. The pins 403A and 403B extend parallel to the length of the spacer (e.g., from the intermediate portion 68 and / or the second portion 64). In other configurations, the spacer 400 can include more pins (e.g., three, four or more) arranged over at least a portion of the width of the spacer that have a gap between each adjacent pin. Each pin can have the same cross-sectional dimensions (e.g., diameter), or at least one pin can have a larger cross-sectional dimension than at least one other pin. For example, the innermost pin (e.g., the centrally located pin) can have a larger cross-sectional diameter than the most lateral pins. Further, although the pins 403A and 403B are illustrated as being arranged to provide a laterally offset first portion 60, the pins can be arranged to be centrally located by the second portion 64 or otherwise arranged to provide a properly arranged first portion.

[0067] When constituted by pins 403A and 403B, the ends or tips of the pins can be round and / or tapered (e.g., with respect to a point) so as to provide easier insertion of the pins into the space between the two bones. FIG. 4L illustrates an exemplary configuration of the spacer of FIG. 4K where the ends 405A and 405B of pins 403A and 403B are tapered with respect to a point so as to facilitate insertion, respectively. Further, the pins 403A and 403B of the spacer 400 can define any polygonal (e.g., square, hexagonal) or arcuate (e.g., circular, elliptical) shape, or even a combination of polygonal and arcuate shapes. For example, the pins can be cylindrical, trapezoidal, triangular, quadrilateral, rectangular, oval, hexagonal, or have other cross-sectional shapes. FIG. 4M illustrates an exemplary configuration of the spacer of FIG. 4K where pins 403A and 403B have a rectangular cross-sectional shape (e.g., across the width of the pin).

[0068] FIG. 5 illustrates a top plan view of an embodiment of the bone preparation guide 450 on the foot and the spacer 400. Like numbers used herein in connection with the bone preparation guide 450 refer to like elements of the bone preparation guide 12. As an example, the bone preparation guide 450 can be placed after one or more bones are realigned by engaging them with a spacer 400 similar to the one described above. For example, the bone preparation guide 450 can be engaged at an intermediate portion of the spacer 400 by moving the opening 30 of the guide 450 over the second portion of the spacer 400. As explained above, by using the spacer 400, the intermediate and second portions, and thus its central longitudinal axis, can be substantially maintained at a desired position, such as the center of the joint. Accordingly, placing the guide 450 using the intermediate and / or second portions of the spacer 400 can result in alignment of the guide 450 at a desired position with respect to the joint, and thus the bones 50 and 52. As a result, bone preparation can proceed efficiently using the guide 450.

[0069] The bone preparation guide 450 can have a variety of different configurations as described above with respect to the bone preparation guide 12 in the configuration illustrated in FIG. 5, but the bone preparation guide 450 includes a cut groove 26 that is in a bent configuration (e.g., oriented at an angle) with respect to the cut groove 28 and / or the joint between the bones 50 and 52. The groove 26 may be inclined with respect to an extension suitable for providing anatomically appropriate bone preparation (e.g., one or more bone cuts) depending on the procedure and thus the anatomical region in which the guide 450 is used. The exemplary angles of inclination discussed above with respect to the cutting guide 12 can also be used for the bone preparation guide 450.

[0070] As shown in the exemplary view of FIG. 5, when using the guide 450 to prepare one or more bones during a procedure on the foot, the groove 26 can be inclined with respect to the TMT joint space and / or the end of the first midfoot bone to cut a portion of the cuneiform bone (e.g., the medial cuneiform 52). The groove 26 can be inclined proximally (e.g., away from the distal end of the medial cuneiform) when the groove extends from the medial side to the lateral side of the medial cuneiform. As a result, the cut made along the groove 26 can result in the excision of the medial cuneiform where the width (e.g., thickness) of the wedge portion gradually increases as it moves from the medial side to the lateral side of the medial cuneiform.

[0071] In some examples, the guide 450 is configured to invert 180 degrees about the frontoparietal plane for interchangeable use on either the patient's right or left foot. For example, if a TMT fusion procedure is being performed on the patient's left foot, the guide 450 can be rotated to a first orientation such that the groove 26 is inclined proximally laterally from the medial side of the left foot. Symmetrically, if a TMT fusion procedure is being performed on the patient's right foot, the guide 450 can be rotated 180 degrees with respect to a second orientation such that the groove 26 is inclined proximally laterally from the medial side of the right foot. The upper and bottom surfaces of the guide 450 may lack protrusions or other structural features that prevent the guide from being inverted and placed on the joint where the guide is cut to form a guide having a bent cut groove for deployment on either foot.

[0072] In some instances, the guide 450 having the refractive groove 26 is provided as part of a kit that includes a plurality of different guides. The guides can vary by having different sizes and / or angles at which the grooves 26 refract relative to each other. During the procedure, the clinician can select, for example, one of a plurality of different guides that best fits the size and / or angle of the cut to be made. To facilitate interchangeability of the guides during the procedure, each of the plurality of guides can have fixation holes (e.g., the first and second adjustable stabilization members 46, 48) that are in the same location relative to each other (e.g., the same separation distance and angle). When configured in this way, the clinician can remove one guide from the fixation forceps into the first intermediate cuneiform 50 and the medial cuneiform 52 (e.g., by pulling the guide up from the pin) and insert a different guide having a groove 26 that refracts at an angle different from the guide removed on the same pin (e.g., by pressing the second guide down on the pin).

[0073] To assist in selecting the appropriate one of a plurality of available guides each having a cut surface that refracts at a different angle, the clinician may take an x-ray of the TMT joint that has been actuated prior to selecting the guide. The clinician may take a dorsal-to-plantar direction x-ray to select and size the cut angle made on the medial cuneiform. The clinician can then select a particular one of a plurality of available guides whose angle will then best fit the size and / or angle of the cut to be made on the TMT joint, particularly at the end of the medial cuneiform that is cut during the procedure.

[0074] In the example of FIG. 5, the groove 26 is shown adjacent to the cuneiform bone, and thus can be configured at an angle that progresses proximally from the inner side portion of the guide 450 that generally corresponds to appropriate bone preparation for the cuneiform bone (e.g., cutting the wedge-shaped portion of the cuneiform bone). That is, the cut made using the groove 26 can produce a progressively thicker bone cut that advances from the inner side of the cuneiform bone to the lateral side portion. In some examples, the end of the groove 26 on the lateral side portion of the guide 450 can be inclined 2-10 degrees relative to the end of the groove 26 on the inner side portion of the guide 450. In a further example, the end of the groove 26 on the lateral side portion of the guide 450 can be inclined 2-5 degrees relative to the end of the groove 26 on the inner side portion of the guide 450. By using the guide 450 having the angled groove 26 in combination with the spacer 400 as shown, bone preparation of the bone 52 can be provided in an anatomically appropriate manner even after the bone 50 has been realigned.

[0075] Figures 6A-6D illustrate embodiments of the tissue removal site confirmation member 80. FIGS. 6A and 6B show perspective views of the separated bone preparation guide 12 and the tissue removal instrument site confirmation member 80, and FIGS. 6C and 6D show perspective views of the bone preparation guide 12 and the tissue removal instrument site confirmation member 80 on the foot. The tissue removal instrument site confirmation member 80 can serve a function that enables a surgeon to visualize the location and / or orientation of a cut being made using the guide 12. In some embodiments, the spacer and the tissue removal instrument site confirmation member 80 can be engaged with the guide 12 simultaneously.

[0076] The tissue removal instrument location confirmation member 80 can include a first portion 82 and a second portion 84. In some embodiments, similarly, the member 80 can further include an opening 86 defined between the first portion 82 and the second portion 84. The member 80 can be engageable with the guide 12 via the first portion 82 of the member 80, such as in the groove 26 or 28 or the opening 30. As shown, the first portion 82 is engaged with the guide 12 in the groove 28 and can extend downwardly through the groove 28 in some instances. In other examples, the first portion 82 can be engaged with the guide 12 in the groove 26 or the opening 30. Depending on the configuration of the tissue removal instrument location confirmation member 80, in some examples, the first portion 82 can be engaged with the guide 12 at more than one of the groove 26, the groove 28, and the opening 30.

[0077] The second portion 84 is connected to or integral with the first portion 82, extends from and is spaced apart from the first portion 82. As shown, the second portion 84 can be configured to extend out from the guide 12 while the first portion 82 is engaged with the guide 12. For example, the first portion 82 can be within the groove 28 of the guide 12 and the second portion 84 can be spaced outwardly (e.g., radially) from the first portion 82 out of the groove 28. The second portion 84 can have a width less than the width of the first portion 82 and can additionally include a curvature along its length. As shown, the second portion 84 includes a curvature along its length in a direction toward the guide 12 when the first portion 82 is engaged with the guide 12. In embodiments where the opening 86 is included within the member 80, the opening 86 can be configured to receive a portion of bone such that the second portion 84 can extend outwardly around such bone portion received within the opening 86.

[0078] The first portion 82 and the second portion 84 can be designed to be complementary portions. Specifically, in some examples, the position of the second portion 84 can correspond to the position of the first portion 82 in a partially predetermined manner. For example, when the member 80 is properly engaged with the guide 12, the tip of the second portion 84 can extend to the same depth as the bottom edge of the first portion 82 (e.g., the tip of the second portion 84 and the bottom edge of the first portion 82 extend along the same plane). In such an example, by visually inspecting the depth of the second portion 84 (e.g., extending outside the guide 12), a display regarding the depth of the first portion 82 can be provided. This can be beneficial in applications where the bottom edge of the first portion 82 is inserted into tissue and not easily visible to the surgeon, while the second portion 84 extends out of the tissue and is visible to the surgeon. Thus, in some examples, the second portion 84 can enable the surgeon to confirm the depth of the first portion 82 within the tissue by simply looking at the second portion 84 outside the tissue. In some cases, the depth of the second portion 84 can directly correspond to the depth of the first portion 82, and in other cases, the correspondence between the first and second portions can be a predetermined ratio.

[0079] The tissue removal instrument location confirmation member 80 can be engaged with the guide 12 in a manner that allows the member 80 to rotate relative to the guide 12 while the member 80 is engaged with the guide 12. This can be seen by comparing the position of the member 80 in FIG. 6A to the position of the member 80 in FIG. 6B. For example, the member 80 can be configured such that, by a rotational movement applied to the member 80, the second portion 84 can rotate around the guide 12 from the position shown in FIG. 6A to the position shown in FIG. 6B, and in some instances, the second portion 84 can be positioned downward from the guide 12 while the first portion 82 is engaged in one of the grooves 26, 28, or the opening 30. In some applications, the opening 86 can receive a portion of the bone overlying the opening 86 and allow the second portion 84 to extend outwardly around the bone, thereby facilitating rotation of the second portion 84 around the portion of the bone. Thus, the opening 86 can facilitate rotation of the member 80 while the member 80 is engaged with the guide 12 by preventing interference between the member 80 and a portion of the bone adjacent to the member 80 and the second portion 84.

[0080] When the guide 12 is placed on the foot (as shown in FIGS. 6C and 6D), the member 80 can be engaged with the guide 12. As described, the first and second portions 82, 84 can be designed as complementary portions. In such an example, when the member 80 is engaged with the guide 12 on the foot, the first portion 82 extends to the same depth and location that contacts this bone end when using the guide 12 (e.g., through a groove defined within the guide) and can contact the bone end. While the first portion 82 extends to the bone, the second portion 84 of the member 80 can function as an external extension from the guide 12 that protrudes under the side of the bone (e.g., 50 or 52) at the same trajectory and / or depth where the cutting instrument is positioned when inserted through the groove of the guide 12. This is because the first and second portions 82, 84 can be complementary. Thus, the second portion 84 can serve to provide an indication regarding the trajectory and / or depth at which the cutting instrument contacts the bone end. In this way, the member 80 (e.g., the second portion 84 that functions as an external extension) can enable a surgeon to confirm the position and / or orientation of one or more preparation grooves of the guide 12 with respect to the ends of one or more bones 50, 52 before performing a bone preparation operation on one or more bones 50, 52. Thus, the member 80 can facilitate visualization of the cutting depth and / or trajectory that would result from the current position and orientation of the guide 12 and can enable the surgeon to adjust the position and / or orientation of the guide 12 as may be necessary for the desired application.

[0081] In some cases, in addition to, or as an alternative to, visualization using member 80 (e.g., visualization of the position of complementary second portion 84), imaging techniques (e.g., radiographs) can be used in conjunction with member 80. For example, in one embodiment, member 80 can be engaged with guide 12 such that when using guide 12 in conjunction with a cutting instrument, the first portion 82 contacts the bone end at the same depth and location where the first portion extends into the tissue and the cutting instrument contacts this bone end. Next, the foot can be imaged using an appropriate imaging technique while the first portion of member 80 is within the tissue. The image obtained from the imaging technique can show the first portion of member 80 with respect to the bone end desired to be prepared for a particular application and can provide an indication regarding the proposed cutting depth and / or trajectory. This then enables adjustment of the position and / or orientation of guide 12 required before the surgeon performs the desired preparation operation on this bone end.

[0082] Member 80 can be any component that protrudes from a guide (e.g., a guide groove of the guide) in a way that enables visualization of the bone preparation position, trajectory, and / or thickness. In some cases, both spacer 14 and member 80 can be used in the procedure to visualize the proposed bone preparation and to facilitate any adjustments to such bone preparation. As shown, member 80 can be a separate component. As noted, member 80 can engage with guide 12 and, in some examples, additionally or alternatively, can engage with spacer 14. However, in other embodiments, member 80 can be integral with spacer 14 and / or guide 12.

[0083] In some embodiments, the instrument location confirmation member 80 can indicate the location where the tissue removal instrument intersects both the first and second bones. Such embodiments include an instrument location confirmation member having a first confirmation member and a second confirmation member (either or both of which may include some or all of the features described above with respect to the single member 80) connected together with a bridging member or the like. The first confirmation member can be received within the guide groove 26, and the second confirmation member can be received simultaneously with the guide groove 28.

[0084] Figures 7 and 8 show perspective views of a tissue removal instrument 90 being used in conjunction with the bone preparation guide 12. In some examples in Figure 7 etc., the spacer 14 can be engaged with the guide 12 and one or more bones can be prepared using the instrument 90. In other examples in Figure 8 etc., the spacer 14 can be removed from the guide 12 prior to use of the instrument 90. When the spacer 14 is removed, the guide 12 can be fixed in place by use of a fixing device etc. through the guide 12 along the foot resulting from use as a reference for the spacer 14.

[0085] Figure 9 shows a side perspective view of the foot 200 illustrating bone plates 310, 320 spanning the joint between the first intermediate cuneiform bone 210 and the medial cuneiform bone 220. After preparation of one or more bones, the ends of the prepared bones can be placed in parallel, optionally compressed together, and fixed by a bone fixation device. Figure 9 illustrates a threaded olive pin 300 inserted through the first intermediate cuneiform bone 210 into the medial cuneiform bone 220 to provide compression between the first intermediate cuneiform bone and the medial cuneiform bone. Next, the position of the bones can be fixed by one or more bone fixation devices. Figure 9 shows a first bone plate 310 (e.g., a straight or curved bone plate positioned dorsomedially) and a second bone plate 320 (e.g., a helical bone plate positioned from the medial side of the cuneiform bone to the bottom side of the intermediate cuneiform bone (other embodiments may include a second linear bone plate, not shown)) spanning the joint space. After the screws are inserted and / or the plates are applied by insertion of bone screws, the olive pin can be removed.

[0086] Embodiments of the present invention also include methods such as methods for fixing the orientation of a bone or a plurality of bones. Generally, one way to position a bone is to move the bone from a position that is anatomically misaligned relative to another bone to an anatomically aligned position, and after moving the bone into the aligned position, preparing the end of the moved bone and the opposing end of another bone.

[0087] In some embodiments, the method includes preparing a joint for a corrective procedure. For example, after creating a surgical access to the joint and before moving the bone into the aligned position, soft tissue may be released to allow a bone such as a midfoot bone to rotate freely. In some embodiments, bone obstructions may be resected (e.g., the midfoot bone base flare, or bone spurs) to further facilitate free rotation.

[0088] In some embodiments, the location of the intersection of the tissue removal instrument and the bone to be prepared is identified prior to bone preparation. In one embodiment, the tissue removal instrument location confirmation member may be engaged with a preparation guide to visually confirm the location where the tissue removal instrument contacts the bone. In another embodiment, a tissue spacer is engaged with the preparation guide to provide a reference for the position and / or orientation of a cut made through one or more defined by the guide. In any embodiment, such visual confirmation may include the use of an imaging device such as a radiograph. If the position of the preparation guide is correct, additional fixation devices (e.g., pins) may be created through holes (e.g., angled holes) to further secure the position of the preparation guide relative to the first midfoot bone and the medial cuneiform bone, or other bones depending on the application. In embodiments where the spacer and guide are provided as separate components, the spacer may be reattached prior to further bone preparation steps.

[0089] After correct alignment of the bone and the preparation guide, the end of the first midfoot bone facing the medial cuneiform bone can be prepared by a tissue removal instrument aligned with the first guide surface, such as by inserting the tissue removal instrument through a groove defined by, for example, the first guide surface and the first opposing surface. And the end of the medial cuneiform bone facing the first midfoot bone can be prepared by a tissue removal instrument aligned with the second guide surface, such as by inserting the tissue removal instrument through a groove defined by the second guide surface and the second opposing surface. In embodiments including cut bone or cartilage, the cuneiform bone cut and the midfoot bone cut are parallel and may coincide with the cut. After the bone is prepared, the guide and any other bone preparation members can be removed, and tissue (e.g., bone or cartilage flakes) can be removed from the joint site.

[0090] As noted, embodiments of the method according to the present invention may also include steps performed after preparing the ends of the bones. For example, the ends of the bones can be placed in parallel and optionally compressed together, and the position of the bones can be fixed by one or more bone fixation devices (e.g., compression bone screws, bone plates, bone staples, external fixators, intramedullary implants or nails) before closing the surgical access to the joint.

[0091] For example, in view of the details provided herein, one method can include inserting a spacer into a joint (e.g., a TMT joint space), and then engaging a guide with the inserted spacer (in embodiments where the guide and spacer are provided as separate components). Alternatively, (in embodiments where the guide and spacer are provided as separate components) the spacer can be inserted into the joint while the guide is left in place on the foot. In another embodiment, the guide and spacer can be positioned together. Next, the spacer can be used as a reference for positioning and / or orienting the guide at an appropriate location with respect to one or more bones for the intended use. In some examples, the tissue removal instrument location confirmation member can be used, additionally or alternatively, to provide an indication regarding the depth and / or trajectory of a cut made through a groove defined by the guide on the foot. In some cases, the location of the guide with respect to one or more bones to be prepared can be adjusted according to a reference obtained from the spacer and / or the tissue removal instrument location confirmation member. After the guide is properly positioned, the guide can be fixed to the foot through a fixing device (e.g., a pin) inserted through a hole defined within the guide. After fixing the guide to the foot, the spacer and / or the tissue removal instrument location confirmation member can be removed. In some examples, the spacer and / or the tissue removal instrument location confirmation member can remain engaged with the guide after the guide is fixed to the foot, as long as there is no interference with the tissue removal instrument. Next, the tissue removal instrument can be inserted through the guide (e.g., through a groove defined within the guide) to prepare one or more bones at the location of the fixed guide. Any cut portion of the bone resulting from the use of the tissue removal instrument can be removed from the joint. The prepared bones can have their respective ends juxtaposed together, and fixation (e.g., one or more bone plates) can be applied for fusion of the prepared bone ends.

[0092] Embodiments of the present invention also include a disposable sterile kit including embodiments of the bone positioning guide, bone preparation guide, spacer, and / or tissue removal instrument location confirmation member described herein. Other components that may be included within the sterile kit include bone fixation devices such as bone plates and / or pins and tissue removal instruments.

[0093] Accordingly, embodiments of the present invention are disclosed. The present invention is described with reference to certain disclosed embodiments, which are presented for purposes of illustration and not limitation, and other embodiments of the present invention are possible. Those skilled in the art will understand that various changes, adaptations, and modifications can be made without departing from the spirit of the present invention. [Configuration 1] A method for preparing one or more bones, comprising: inserting a spacer into a space defined between a first bone and a second bone; aligning a bone preparation guide with a portion of the first bone or the second bone while the spacer is inserted within the space, using the spacer as a reference; and using the bone preparation guide to contact a portion of the first bone or the second bone with a tissue removal instrument to guide the tissue removal instrument. A method for preparing one or more bones, comprising the above steps. [Configuration 2] The method according to Configuration 1, wherein inserting the spacer and aligning the bone preparation guide first comprises inserting the spacer as a separate component into the space and then engaging the bone preparation guide with the inserted spacer to align the bone preparation guide with the portion of the first bone or the second bone. [Configuration 3] The method according to Configuration 2, wherein engaging the bone preparation guide with the inserted spacer comprises receiving the spacer within an opening defined within the body of the bone preparation guide while the spacer is inserted within the space. [Configuration 4] The method according to Configuration 1, wherein inserting the spacer and aligning the bone preparation guide includes inserting the spacer into the space while the spacer is engaged with the bone preparation guide. [Configuration 5] The method according to Configuration 1, wherein using the bone preparation guide to bring the portion of the first bone or the second bone into contact with the tissue removal instrument includes aligning the tissue removal instrument with the guide surface of the bone preparation guide. [Configuration 6] The method according to Configuration 5, wherein aligning the bone preparation guide with the portion of the first bone or the second bone includes aligning the guide surface with the portion of the first bone or the second bone. [Configuration 7] The method according to Configuration 1, further comprising engaging a tissue removal location confirmation member with the bone preparation guide, wherein a first portion of the member extends toward the first bone and / or the second bone, and a second portion of the member protrudes from the bone preparation guide toward a side portion of the first or second bone. [Configuration 8] The method according to Configuration 7, further comprising rotating the tissue removal location confirmation member around the first bone or the second bone while the member is engaged with the bone preparation guide. [Configuration 9] The method according to Configuration 1, wherein aligning the bone preparation guide using the spacer as a reference includes longitudinally positioning the guide surface of the bone preparation guide on the first bone or the second bone at a position defined by the distance between the guide surface and the spacer. [Configuration 10] The method according to Configuration 1, wherein aligning the bone preparation guide using the spacer as a reference includes orienting the guide surface of the bone preparation guide at an angle defined by the angle between the first bone or the second bone and the spacer with respect to the first bone or the second bone. [Configuration 11] The method according to Configuration 1, wherein inserting the spacer includes inserting the spacer such that the spacer contacts at least a side edge portion of an end face of the first bone and a side edge portion of an end face of the second bone. [Configuration 12] The method according to Configuration 1, wherein inserting the spacer includes inserting the spacer such that the spacer contacts at least one-third in the lateral direction of an end face of the first bone and one-third in the lateral direction of an end face of the second bone. [Configuration 13] The method according to Configuration 1, wherein inserting the spacer includes positioning a first portion of the spacer in the space such that a central longitudinal axis of the first portion is laterally spaced from a central longitudinal axis of a second portion of the spacer. [Configuration 14] The first bone is a first intermediate cuneiform bone having an end face, the second bone is a medial cuneiform bone having an end face facing the end face of the first intermediate cuneiform bone, and inserting the spacer includes inserting the first portion such that the spacer contacts a lateral half of the end face of the first intermediate cuneiform bone and a lateral half of the end face of the medial cuneiform bone without contacting an inner half of the end faces of the first intermediate cuneiform bone and the medial cuneiform bone. The method according to Configuration 13. [Configuration 15] The method according to Configuration 14, further including moving the first intermediate cuneiform bone to reduce an intermetatarsal angle between the first intermediate cuneiform bone and a second intermediate cuneiform bone after inserting the spacer and before aligning the bone preparation guide. [Configuration 16] Before aligning the bone preparation guide with the portion of the first bone or the second bone, taking an X-ray image of at least one of the first bone and the second bone; determining a cutting angle to be made based on the X-ray image; The method according to Configuration 1, further comprising selecting the bone preparation guide from a plurality of different bone preparation guides each having a different cutting angle so as to have a cutting angle corresponding to the cutting angle determined based on the X-ray photograph. [Configuration 17] The method according to Configuration 1, wherein the spacer is tapered in thickness across its width. [Configuration 18] The method according to Configuration 1, wherein the spacer includes at least two pins separated from each other, and inserting the spacer includes inserting the at least two pins into the space defined between the first bone and the second bone. [Configuration 19] A bone preparation guide, comprising: A body having a first guide surface defining a first preparation plane and a second guide surface defining a second preparation plane, the first and second guide surfaces being spaced apart from each other at a certain distance; A first end extending from the body in a first direction and a second end extending from the body in a second direction, the second direction being different from the first direction, each of the first end and the second end including a fixing hole configured to receive a fixing device; A spacer extending from the body in a third direction, the third direction being different from the first and second directions, the spacer being configured to be placed within a joint space between opposing bones. [Configuration 20] The bone preparation guide according to Configuration 19, further including an opening disposed between the first and second guide surfaces, the spacer being engageable with the body within the opening. [Configuration 21] The bone preparation guide according to Configuration 19, further comprising a tissue removal instrument location confirmation member having a first portion engageable with the body and configured to extend to the first bone and / or the second bone. [Configuration 22] The bone preparation guide according to Configuration 21, wherein the tissue removal tool location confirmation member further includes a second portion that extends outward from the main body and is spaced apart from the first portion when the tissue removal tool location confirmation member is engaged with the main body. [Configuration 23] The bone preparation guide according to Configuration 19, further comprising an adjustable stabilization member engaged with the first end or the second end. [Configuration 24] The bone preparation guide according to Configuration 23, wherein the adjustable stabilization member is cannula-shaped. [Configuration 25] The bone preparation guide according to Configuration 19, wherein the second plane is parallel to the first plane. [Configuration 26] The bone preparation guide according to Configuration 19, further comprising a first opposing surface spaced apart from the first guide surface defining the first preparation groove and a second opposing surface spaced apart from the second guide surface defining the second preparation groove. [Configuration 27] The bone preparation guide according to Configuration 19, wherein the spacer is movable relative to the main body of the bone preparation guide when the spacer is engaged with the main body of the bone preparation guide. [Configuration 28] The bone preparation guide according to Configuration 19, wherein the spacer includes a first portion configured to extend into the joint space and a second portion opposing the first portion extending on the main body. [Configuration 29] The bone preparation guide according to Configuration 28, wherein the first portion includes a keel. [Configuration 30] The bone preparation guide according to Configuration 28, wherein the second portion includes at least one recess. [Configuration 31] The bone preparation guide according to Configuration 28, further comprising an intermediate portion disposed between the first portion and the second portion, the intermediate portion being engageable with the main body. [Configuration 32] A spacer configured to be inserted into a joint space between first and second opposing bones, A first portion configured to extend within the joint space, and a second portion opposite the first portion configured to extend over the joint space, and an intermediate portion disposed between the first portion and the second portion, the spacer being configured to function as a reference for positioning a tissue removal instrument relative to the first and / or second bone. [Configuration 33] The intermediate portion provides a first guide surface on a first side portion of the spacer and a second guide surface on a second, opposing side portion of the spacer, the first and second guide surfaces each defining a plane for guiding the tissue removal instrument, the spacer according to Configuration 32. [Configuration 34] The intermediate portion has a thickness, the first portion has a thickness, and the thickness of the intermediate portion is different from the thickness of the first portion, the spacer according to Configuration 33. [Configuration 35] The central longitudinal axis of the first portion is spaced from the central longitudinal axis of the second portion, the spacer according to Configuration 32. [Configuration 36] The intermediate portion is configured to engage the body of a bone preparation guide, the spacer according to Configuration 32. [Configuration 37] The first portion includes a keel, the spacer according to Configuration 32. [Configuration 38] The second portion includes at least one recess, the spacer according to Configuration 32. [Configuration 39] The first, second, and intermediate portions are integral, the spacer according to Configuration 32. [Configuration 40] At least the first portion is tapered in thickness over its width, the spacer according to Configuration 32. [Configuration 41] The first portion is defined by at least two pins separated from each other and having a gap therebetween, the spacer according to Configuration 32.

Claims

Claim 1 A cuneiform bone adjustment system, comprising: a plurality of bone adjustment guides, each bone adjustment guide defining a guide surface configured to be positioned on an end portion of a cuneiform bone to be cut, the guide surface of each of the plurality of bone adjustment guides being configured to guide a tissue removal instrument for cutting the end portion of the cuneiform bone, and a cutting angle defined by the guide surface of a selected one of the plurality of bone adjustment guides being different from a cutting angle defined by another guide surface of each of the plurality of bone adjustment guides; at least one fixing device positionable across a calcaneocuboid joint that separates a midfoot bone from the cuneiform bone, the at least one fixing device being configured to fix a moved position of the midfoot bone relative to the cuneiform bone; a system comprising the above. Claim 2 The system according to claim 1, wherein each of the plurality of bone adjustment guides further comprises a spacer integral with the bone adjustment guide, the spacer extending downward and being configured to be inserted into the calcaneocuboid joint for orienting the guide surface. Claim 3 The system according to claim 1, wherein each of the plurality of bone adjustment guides further comprises an opening configured to selectively engage the spacer, the spacer being configured to be inserted into the calcaneocuboid joint for orienting the guide surface. Claim 4 The system according to claim 1, wherein a main body of each of the plurality of bone adjustment guides extends from a first end portion configured to be positioned on the midfoot bone to a second end portion configured to be positioned on the cuneiform bone separated from the midfoot bone by the calcaneocuboid joint, and each bone adjustment guide includes a first fixing hole configured to receive a first fixing pin for fixing the main body to the midfoot bone and a second fixing hole configured to receive a second fixing pin for fixing the main body to the cuneiform bone. Claim 5 The system according to claim 4, further comprising the first fixing pin and the second fixing pin. Claim 6 The first fixing hole includes a first midfoot bone side fixing hole and a second midfoot bone side fixing hole. The second fixing hole includes a first cuneiform bone side fixing hole and a second cuneiform bone side fixing hole. The system according to claim 4. Claim 7 The system according to claim 1, wherein the intermediate foot bone is the first intermediate foot bone and the cuneiform bone is the medial cuneiform bone.

8. The system according to claim 1, further comprising the tissue removal instrument.

9. The system according to claim 8, wherein the tissue removal instrument is selected from the group consisting of a saw, a rotary bar, and combinations thereof.

10. The system according to claim 8, wherein the tissue removal instrument is a saw.

11. The system according to claim 1, wherein the fixing device comprises one or more of a bone plate, a screw, and a staple.

12. The guide surface of the selected one of the plurality of bone adjustment guides defines a cuneiform bone side cutting groove, and the selected one of the plurality of bone adjustment guides comprises a middle foot bone side cutting groove configured to be positioned on an end portion of the middle foot bone. The system according to claim 1.

13. The system according to claim 12, wherein the cuneiform bone side cutting groove is refracted with respect to the middle foot bone side cutting groove.

14. The system according to claim 12, wherein the cuneiform bone side cutting groove is spaced apart from the middle foot bone side cutting groove by a certain distance.

15. The system according to claim 14, wherein the certain distance is defined between the nearest plane of the cuneiform bone side cutting groove and the farthest plane of the middle foot bone side cutting groove and is within a range of 2 millimeters to 10 millimeters.

Images