Bi-planar instrument for bone cutting and joint realignment procedure

Abstract

To provide a bi-planar instrument for a bone cutting and joint realignment procedure.SOLUTION: A technique for correcting a bone deformity, such as hallux valgus, may be performed using an instrument that defines a spacer body connected to a fulcrum. The spacer body portion of the instrument can be inserted into a joint space between opposed bone ends. The fulcrum body can be inserted between adjacent metatarsals. An angle set between the spacer body and fulcrum body can help properly position both features within different joint spaces for ensuring that subsequent steps of the surgical procedure are properly performed and instrumentation is appropriately aligned.SELECTED DRAWING: Figure 5A

Description

[Technical field]

[0001] cross reference This application claims the benefit of U.S. Provisional Patent Application No. 62 / 883,649, filed Aug. 7, 2019, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to surgical devices and, more particularly, to surgical devices for assisting in bone cutting and / or realignment techniques. [Background technology]

[0003] Bones in the human body, such as the bones of the foot, can be anatomically misaligned. For example, one common type of bone deformity is hallux valgus, a progressive foot deformity in which the first metatarsophalangeal joint is affected, often resulting in significant functional disability and foot pain. The metatarsophalangeal joint is misaligned medially, with the first metatarsal bone abducting while the phalanges adduct. This often leads to the development of soft tissue and a bony prominence on the medial side of the foot, called hallux valgus.

[0004] Surgical intervention may be used to correct hallux valgus deformity. There are a variety of different surgical procedures to correct hallux valgus deformity, which may involve removing the abnormal bony enlargement of the first metatarsal and / or attempting to realign the first metatarsal with respect to the adjacent metatarsal. Surgical instruments that can facilitate efficient, accurate, and reproducible clinical results are useful to practitioners performing bone realignment techniques. Summary of the Invention

[0005] In general, the present disclosure is directed to an instrument that may be used during a surgical bone cutting and / or realignment procedure. The instrument may include a spacer body connected to a fulcrum body. The spacer body and the fulcrum body may be positionable in adjacent joint spaces, with a connecting member between the spacer body and the fulcrum body serving to control the relative position of the spacer body and the fulcrum body when inserted into the respective joint spaces.

[0006] For example, the spacer body can be positioned in a joint space between opposing bone ends, such as the joint space between a metatarsal and an opposing cuneiform bone. In some embodiments, the metatarsal is the first metatarsal bone and the opposing cuneiform is the medial cuneiform bone. In either case, the spacer body can define a first portion positionable in the joint space between the opposing bone ends and a second portion extending superiorly (e.g., dorsally) from the joint space. The second portion of the spacer body can be connected to an osteogenic guide. The osteogenic guide can be removable from the spacer body and engageable with the spacer body (e.g., by inserting the osteogenic guide onto the spacer body after the spacer body is inserted into the joint space). Alternatively, the osteogenic guide can be permanently coupled to the spacer body (e.g., to define a unitary structure). In either case, the osteogenic guide may define one or more guide surfaces for guiding an osteogenic instrument to form the ends of adjacent bones (e.g., to form the end of a metatarsal bone and / or the end of an opposing cuneiform bone). For example, the osteogenic guide may define at least one cutting slot positioned on a metatarsal bone to guide a saw blade to cut the end of the metatarsal bone and at least one cutting slot positioned on an opposing cuneiform bone to guide a saw blade to cut the end of the opposing cuneiform bone.

[0007] The device also includes a fulcrum body coupled to the spacer body. The fulcrum body may be configured (e.g., sized and / or shaped) to be positioned within an intermetatarsal space between adjacent metatarsals, such as the intermetatarsal space between a first metatarsal and a second metatarsal. The fulcrum body may define a fulcrum, or pivot surface, about which the metatarsal may rotate to realign the position of the metatarsal relative to the opposing cuneiform bone and / or adjacent metatarsal. For example, the fulcrum body may define a pivot surface about which the proximal base of the metatarsal may pivot when the intermetatarsal angle is closed between the metatarsal and the adjacent metatarsal. This may help prevent the base of the metatarsal from shifting laterally, such as by compressing against the adjacent metatarsal, when the metatarsal is realigned.

[0008] In some configurations, the spacer body is coupled to the fulcrum body with a bridge member. The bridge member may transition from one plane in which the spacer body is positioned (e.g., generally, the frontal plane) to a second plane in which the fulcrum body is positioned (e.g., generally, the sagittal plane). For example, the bridge member may define an angle (e.g., ranging from 60 degrees to 120 degrees, e.g., having an included angle of 80 degrees to 100 degrees, or about 90 degrees) that operably connects the spacer body to the fulcrum body. In use, the bridge member may be positioned relative to the corner of the metatarsal bone being realigned, such as the proximal transverse angle / surface of the metatarsal bone. When so positioned, the spacer body may be positioned within the joint space between the metatarsal bone and the opposing cuneiform bone, while the fulcrum body may be positioned within the joint space between the metatarsal bone and the adjacent metatarsal bone. The bridge member may help to establish a fixed position between the spacer body and the fulcrum body and / or prevent the spacer body and the fulcrum body from shifting relative to each other and / or within their respective joint spaces during a surgical procedure, which may help to ensure that the spacer body and the fulcrum body are properly positioned for a subsequent procedure step performed using the spacer body and the fulcrum body (e.g., performing an osteogenic step using an osteogenic guide attached to the spacer body and / or realigning the metatarsals by pivoting about the fulcrum body).

[0009] In one example, a biplanar instrument for bone cutting and joint realignment procedures is described. The instrument includes a spacer body configured to be inserted into a joint space between a metatarsal bone and an opposing cuneiform bone of the foot. The instrument also includes a fulcrum body coupled to the spacer body, the fulcrum body configured to be inserted into an intermetatarsal space between the metatarsal bone and an adjacent metatarsal bone.

[0010] In another example, a method is described that includes inserting a spacer body into a joint space between a metatarsal and an opposing cuneiform bone. The method also includes inserting a fulcrum body coupled to the spacer between the metatarsal and an adjacent metatarsal. The method further involves using an osteogenic guide aligned with the spacer to guide an osteogenic instrument to form an end of the metatarsal and using an osteogenic guide to guide an osteogenic instrument to form an end of the opposing cuneiform bone. Additionally, the method includes moving the metatarsal relative to the adjacent metatarsal in at least a transverse plane, thereby pivoting the metatarsal about the fulcrum body and reducing the intermetatarsal angle between the metatarsal and the adjacent metatarsal.

[0011] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0012] [Figure 1A] 1A and 1B are front views of the foot showing a normal first metatarsal position and an exemplary frontal plane rotational deviation position, respectively. [Figure 1B] 1A and 1B are front views of the foot showing a normal first metatarsal position and an exemplary frontal plane rotational deviation position, respectively. [Figure 2A] 2A and 2B are top views of the foot showing a normal first metatarsal position and an exemplary transverse plane deviation position, respectively. [Figure 2B] 2A and 2B are top views of the foot showing a normal first metatarsal position and an exemplary transverse plane deviation position, respectively. [Figure 3A] 3A and 3B are side views of the foot showing a normal first metatarsal position and an exemplary sagittal deviation position, respectively. [Figure 3B] 3A and 3B are side views of the foot showing a normal first metatarsal position and an exemplary sagittal deviation position, respectively. [Figure 4A]4A and 4B are perspective and top views, respectively, of an exemplary bone positioning operation in which a biplanar instrument is positioned in a first joint space and an intersecting second joint space. [Figure 4B] 4A and 4B are perspective and top views, respectively, of an exemplary bone positioning operation in which a biplanar instrument is positioned in a first joint space and an intersecting second joint space. [Figure 5A] 5A and 5B are perspective and top views, respectively, of an exemplary configuration of the biplanar instrument of FIGS. 4A and 4B. [Figure 5B] 5A and 5B are perspective and top views, respectively, of an exemplary configuration of the biplanar instrument of FIGS. 4A and 4B. [Figure 5C] 5C and 5D are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a concave bone contacting surface. [Figure 5D] 5C and 5D are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a concave bone contacting surface. [Figure 5E] 5E and 5F are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a convex bone contacting surface. [Figure 5F] 5E and 5F are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a convex bone contacting surface. [Figure 6A] 6A and 6B are perspective and top views, respectively, showing an exemplary osteogenic guide that may be used as part of a surgical procedure involving a biplanar instrument. [Figure 6B] 6A and 6B are perspective and top views, respectively, showing an exemplary osteogenic guide that may be used as part of a surgical procedure involving a biplanar instrument. [Figure 7A] 7A and 7B are perspective and top views, respectively, of an exemplary configuration of a biplanar instrument in which the spacer body is detachable from and attachable to the fulcrum body. [Figure 7B]7A and 7B are perspective and top views, respectively, of an exemplary configuration of a biplanar instrument in which the spacer body is detachable from and attachable to the fulcrum body. [Figure 8A] 8A and 8B are front and rear perspective views, respectively, of an exemplary configuration of a biplanar instrument configured with hinge connections. [Figure 8B] 8A and 8B are front and rear perspective views, respectively, of an exemplary configuration of a biplanar instrument configured with hinge connections. [Figure 9A] 9A-9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary biplanar instrument shown in FIGS. 8A and 8B. [Figure 9B] 9A-9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary biplanar instrument shown in FIGS. 8A and 8B. [Figure 9C] 9A-9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary biplanar instrument shown in FIGS. 8A and 8B. [Figure 9D] 9A-9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary biplanar instrument shown in FIGS. 8A and 8B. [Figure 10A] 10A-10C show an exemplary system including a biplanar instrument and an osteogenic guide, where the osteogenic guide is sized to move relative to the spacer body of the biplanar instrument. [Figure 10B] 10A-10C show an exemplary system including a biplanar instrument and an osteogenic guide, where the osteogenic guide is sized to move relative to the spacer body of the biplanar instrument. [Figure 10C] 10A-10C show an exemplary system including a biplanar instrument and an osteogenic guide, where the osteogenic guide is sized to move relative to the spacer body of the biplanar instrument. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] In general, the present disclosure is directed to an instrument including a spacer body and a fulcrum body that may be used in surgical procedures, such as bone realignment procedures. Exemplary procedures in which the fulcrum structure may be used include bone alignment, osteotomy, fusion procedures, and / or other procedures in which one or more bones are manipulated and / or realigned relative to one or more other bones. Such procedures may be performed on bones that are relatively small, such as bones of the foot or hand (e.g., adjacent bones separated by a joint or different portions of a single bone), compared to bones in other parts of the human anatomy. In one example, a procedure utilizing an instrument including two bodies joined together by a bridge member may be performed to correct alignment between a metatarsal (e.g., first metatarsal) and a second metatarsal and / or cuneiform (e.g., medial, or first cuneiform), such as in hallux valgus correction surgery. An example of such a procedure is the Lapidus procedure (also known as first tarsal-metatarsal fusion). Although the exemplary instruments of the present disclosure have been described as generally useful for insertion into the space between opposing bone ends that transition into the intermetatarsal space, the instruments may be used in any desired application, and the present disclosure is not limited in this respect.

[0014] 1-3 are different views of a foot 200 showing exemplary anatomical misalignments that may occur and be corrected using fulcrums in accordance with the present disclosure. Such misalignments may be caused by hallux valgus (bunion), natural growth deformities, or other conditions that cause anatomical misalignments. FIGS. 1A and 1B are frontal views of the foot 200 showing a normal first metatarsal position and an exemplary frontal rotational misalignment position, respectively. FIGS. 2A and 2B are top views of the foot 200 showing a normal first metatarsal position and an exemplary transverse plane misalignment position, respectively. FIGS. 3A and 3B are side views of the foot 200 showing a normal first metatarsal position and an exemplary sagittal plane misalignment position, respectively. Although FIGS. 1B, 2B, and 3B each show a misalignment in the respective plane alone, in practice the metatarsals may be misaligned in any two of the three planes, or all three planes. Thus, it should be understood that the depiction of a single plane of misalignment in each of Figures 1B, 2B, and 3B is for illustrative purposes, and that the metatarsals may be misaligned in multiple planes that are desirably corrected.

[0015] 1A and 2A, a foot 200 is comprised of a number of bones including a first metatarsal 210, a second metatarsal 212, a third metatarsal 214, a fourth metatarsal 216, and a fifth metatarsal 218. The metatarsals are distally connected to a phalange 220, and more specifically, each is connected to a respective proximal phalange. The first metatarsal 210 is proximally connected to a medial cuneiform 222, the second metatarsal 212 is proximally connected to a middle cuneiform 224, and the third metatarsal is proximally connected to a lateral cuneiform 226. The fourth and fifth metatarsals 216, 218 are proximally connected to a cuboid 228. The joints 230 between the metatarsals and the respective cuneiform bones (e.g., first metatarsal 210 and medial cuneiform 222) are referred to as tarsometatarsal ("TMT") joints. The joints 232 between the metatarsals and the respective proximal phalanges are referred to as metatarsophalangeal joints. The angle 234 between adjacent metatarsals (e.g., first metatarsal 210 and second metatarsal 212) is referred to as the intermetatarsal angle ("IMA").

[0016] As mentioned above, FIG. 1A is a frontal view of a foot 200 showing a typical position of a first metatarsal 210. The frontal plane, also known as the coronal plane, is generally considered to be any vertical plane that divides the body into anterior and posterior parts. In the foot 200, the frontal plane is a vertically extending plane, perpendicular to an axis that extends from proximal to distal along the length of the foot. FIG. 1A shows the first metatarsal 210 in a typical rotational position in the frontal plane. FIG. 1B shows the first metatarsal 210 with a frontal plane rotational deformation characterized by a rotation angle 236 with respect to the ground, as indicated by line 238.

[0017] FIG. 2A is a top view of a foot 200 showing a typical position of the first metatarsal 210 in a transverse plane. The transverse plane, also known as the horizontal plane, axial plane, or transaxial plane, is considered as any plane that divides the body into superior and inferior parts. In the foot 200, the transverse plane is a plane that extends horizontally and is perpendicular to an axis that extends dorsally to plantarly (top to bottom) across the foot. FIG. 2A shows the first metatarsal 210 with a typical IMA 234 in the transverse plane. FIG. 2B shows the first metatarsal 210 with a transverse plane rotational deformity characterized by a larger IMA caused by the distal end of the first metatarsal 210 pivoting medially relative to the second metatarsal 212.

[0018] FIG. 3A is a side view of a foot 200 showing a typical position of the first metatarsal 210 in the sagittal plane. The sagittal plane is a plane parallel to the sagittal suture that divides the body into right and left halves. In the foot 200, the sagittal plane is a vertically extending plane, perpendicular to an axis extending from proximal to distal along the length of the foot. FIG. 3A shows the first metatarsal 210 with a typical rotational position in the sagittal plane. FIG. 3B shows the first metatarsal 210 with a sagittal plane rotational deformation characterized by a rotation angle 240 with respect to the ground, as indicated by line 238.

[0019] A biplanar instrument according to the present disclosure may define a spacer body extending from the medial to lateral direction of the foot (e.g., parallel to the frontal plane) coupled to a fulcrum body extending from the proximal to the distal direction of the foot (e.g., parallel to the sagittal plane). A connecting member may couple the spacer body to the fulcrum body and transition from the frontal plane to the sagittal plane. In some instances, the connecting member may coincide with (e.g., contact) the area of ​​the metatarsal that is being realigned to the proximal end face of the metatarsal and also to the lateral proximal end of the metatarsal. The biplanar instrument may be used as part of a bone positioning technique to correct an anatomical misalignment of one or more bones. In some applications, the technique involves realigning the metatarsal relative to the adjacent cuneiform bone and / or the adjacent metatarsal. The metatarsal undergoing realignment may be anatomically misaligned in the frontal, transverse, and / or sagittal planes, as illustrated and discussed with respect to Figures 1-3 above. Thus, realignment may involve releasing the misaligned metatarsal bone, or a portion thereof, for realignment, and then realigning the metatarsal bone in one or more planes, two or more planes, or all three planes. After the metatarsal bone is suitably realigned, it may be fixed to hold and maintain the realigned position.

[0020] While the metatarsals can have a variety of anatomically aligned and misaligned positions, in some instances, the term "anatomically aligned position" means that the angle of the long axis of the first metatarsal 210 relative to the long axis of the second metatarsal 212 is about 10 degrees or less in the transverse and / or sagittal planes. In certain embodiments, the anatomical misalignment can be corrected in both the transverse and frontal planes. In the transverse plane, a normal IMA 234 between the first metatarsal 210 and the second metatarsal 212 is less than about 9 degrees. An IMA 234 of about 9 degrees to about 13 degrees is considered a mild misalignment of the first and second metatarsals. An IMA 234 of more than about 16 degrees is considered a severe misalignment of the first and second metatarsals.

[0021] In some applications, the biplanar instrument is used as part of a realignment technique to anatomically align the first metatarsal 210, or a portion thereof, by positioning the first metatarsal at a different angle relative to the second metatarsal, thereby reducing the IMA from greater than 10 degrees to less than or equal to about 10 degrees (e.g., about 1-5 degrees IMA), including up to a negative angle of about -5 degrees or until it interferes with the second metatarsal.

[0022] With respect to the frontal plane, a normal first metatarsal is positioned such that its crest is generally perpendicular to the ground and / or its sesamoid is generally parallel to the ground and positioned below the metatarsal. This position can be defined as 0 degrees of metatarsal rotation. In a misaligned first metatarsal, the metatarsal is axially rotated from about 4 degrees to about 30 degrees or more. In some embodiments, a biplanar instrument is used as part of a realignment technique to anatomically align the metatarsal by rotating the metatarsal relative to the medial cuneiform bone, thereby reducing the rotation of the metatarsal from about 4 degrees or more to less than 4 degrees (e.g., about 0 to 2 degrees).

[0023] A biplanar instrument defining a spacer body coupled to a fulcrum body according to the present disclosure may be useful for providing a unitary structure (e.g., before and after assembly) that may be positioned between two adjacent intersecting joint spaces, a first joint space between opposing ends of a metatarsal and a cuneiform bone, and an intermetatarsal space between adjacent metatarsals. The spacer body may include a first portion insertable into the joint space and a second portion that protrudes above the joint space. The second portion that protrudes above the joint space may be coupled to an osteogenic guide, thereby facilitating positioning of the osteogenic guide on the metatarsal and / or cuneiform bone between which the spacer body is positioned. The fulcrum body may establish and / or maintain a space between displaced adjacent bones, preventing lateral translation or base shifting of the bones during rotation and / or pivoting.

[0024] For example, the biplanar instrument may include a spacer body positionable in the joint space between the first metatarsal 210 and the medial cuneiform 222. The spacer body may be coupled to an osteogenic guide. The osteogenic guide may include a receiving slot in which a protruding end of the spacer body is positioned, thereby orienting the osteogenic guide relative to the joint space via the spacer body positioned therein. The osteogenic guide may include at least one cutting slot positioned on the end of the first metatarsal 210 and / or the end of the medial cuneiform to be cut, such as at least one metatarsal cutting slot positionable on the end of the first metatarsal 210 to be cut, and at least one cuneiform cutting slot positionable on the end of the medial cuneiform 222 to be cut.

[0025] The biplanar instrument may also include a fulcrum body positionable within the joint space between the first metatarsal 210 and the second metatarsal 212. The fulcrum body may be inserted into a notch between the first metatarsal 210 and the second metatarsal 212 at the base of the metatarsal (e.g., adjacent respective cuneiform bones) prior to moving the first metatarsal, for example, to help avoid shifting the most proximal base of the first metatarsal 210 toward the most proximal base of the second metatarsal 212. The fulcrum body may provide a point about which the first metatarsal 210 may rotate and / or pivot, while helping to minimize or avoid base compression between the first metatarsal and the second metatarsal. Additionally, the use of the fulcrum body allows the first metatarsal 210 and medial cuneiform 222 to be better angled relative to the guide slots (of the osteotomy guide engaged with the spacer body) positioned on the end faces of the bones, providing a better cutting angle through the guide slots than would be possible without the use of the fulcrum body, which may help reduce or eliminate unwanted springback or return positioning of the first metatarsal 210 after the initial realignment of the metatarsals.

[0026] 4A and 4B (collectively referred to as FIG. 4) are perspective and top views, respectively, of an exemplary bone positioning operation in which a biplanar instrument 10 is positioned in a first joint space and an intersecting second joint space, and the bones forming the first and second joint spaces are realigned relative to one or more adjacent bones. In particular, FIG. 4 shows a biplanar instrument 10 having a spacer body 12 coupled to a fulcrum body 14 via a connecting or bridging member 16. The spacer body 12 is positioned at the intersection between the end of a first metatarsal bone 210 and an opposing medial cuneiform bone 222. The fulcrum body 14 is positioned between the first metatarsal bone 210 and the second metatarsal bone 212. The biplanar instrument 10 may be optionally used in combination with other surgical devices, such as a bone positioning guide 20 and an osteogenic guide 30 (FIG. 6). Additional details regarding exemplary bone positioning guides, osteogenic guides, and related technology are described in U.S. patent application Ser. No. 14 / 981,335, filed Dec. 28, 2015, and U.S. patent application Ser. No. 15 / 236,464, filed Aug. 14, 2016, the entire contents of which are incorporated herein by reference.

[0027] 4, the spacer body 12 may be positioned between opposing ends of adjacent bones, such as opposing ends of a metatarsal (e.g., first metatarsal 210) and a cuneiform (e.g., medial cuneiform 222) separated by a joint space. The spacer body 12 may define a length configured to be inserted into the joint space between the two bones (e.g., with at least a portion of the body protruding dorsally above the joint space), a thickness configured to extend between the metatarsal and the opposing cuneiform (e.g., with the first metatarsal 210 and medial cuneiform 222 contacting opposite sides of the spacer body), and a width configured to extend in a medial-to-lateral direction across the foot.

[0028] The spacer body 12 may be positioned at any suitable location across the joint space (e.g., in the anterior plane). The specific positioning of the spacer body 12 during use may be established by the bridge member 16 coupled to the fulcrum body 14. For example, when the biplanar instrument 10 is inserted into the joint space, the bridge member 16 may contact the proximal lateral corner or area of ​​the first metatarsal 210. This may help to limit the extent to which the spacer body 12 may shift medially across the joint space and to secure the spacer body in a medial to lateral direction (e.g., in the frontal plane). In other examples, the biplanar instrument 10 may be inserted into the joint space without the corner defined by the bridge member 16 contacting a bone (e.g., the first metatarsal).

[0029] 4, in different examples, the spacer body 12 may be engageable and separable from the osteogenic guide 30, or may be integral with (e.g., permanently coupled to) the osteogenic guide. The positioning of the spacer body 12 in the joint space may define the positioning of the osteogenic guide 30 coupled thereto, and correspondingly, the guiding of osteogenic instruments facilitated by the osteogenic guide.

[0030] The biplanar instrument 10 also includes a fulcrum body 14. The fulcrum body 14 may be positioned distal to the bone locating guide 20 between the first metatarsal 210 and the second metatarsal 212, or distal to the guide in other applications. As shown, the fulcrum body 14 of the biplanar instrument 10 is shown proximal to the bone locating guide 20, with the fulcrum body positioned within the joint space between the first metatarsal 210 and the second metatarsal (e.g., at the ends of the first and second metatarsals abutting the medial and middle cuneiform bones, respectively). In yet other examples, the fulcrum body 14 may be positioned within the intermetatarsal space between the first metatarsal 210 and the second metatarsal 212 without the use of the bone locating guide 20 and / or the osteogenic guide 30 (FIG. 6).

[0031] In use, the clinician may insert the fulcrum body 16 between the first metatarsal 210 and the second metatarsal 212 at any time before moving the first metatarsal (e.g., by actuating the bone positioning guide 20 or other means of manipulating the bones). In one embodiment, the clinician forms a joint that is being manipulated to release soft tissue and / or resect plantar inflammation from the base of the first metatarsal 210. Either before or after placing the bone positioning guide 20 over the adjacent bone, the clinician inserts the biplanar instrument 10 into the joint space. The clinician may insert the spacer body 12 into the joint space between the first metatarsal 210 and the medial cuneiform 222, and may also insert the fulcrum body 14 into the joint space between the first metatarsal 210 and the second metatarsal 212.

[0032] After inserting the biplanar instrument 10, the clinician may actuate the bone positioning guide 20. For the left foot as shown in FIG. 4, actuation of the bone positioning guide 20 rotates the first metatarsal 210 counterclockwise in the frontal plane (from the patient's perspective) and also pivots in the transverse plane about the fulcrum body. For the right foot (not shown), actuation rotates the first metatarsal clockwise in the frontal plane (from the patient's perspective) and also pivots in the transverse plane about the fulcrum. Thus, for both feet, actuation of the bone positioning guide 20 may supinate the first metatarsal in the frontal plane and pivot the first metatarsal in the transverse plane about the fulcrum body 14.

[0033] Before or after actuating the bone positioning guide 20 (if used), the clinician may engage an osteogenic guide with a portion of the spacer body 12 that protrudes from the joint space between the first metatarsal 210 and the medial cuneiform 222. The spacer body 12 may have a length effective to engage an osteogenic guide therewith. In some embodiments, the clinician places a separate, removable osteogenic guide 30 on the spacer body 12 after inserting the biplanar instrument 10 into the joint space. The clinician may attach the osteogenic guide 30 before or after attaching the bone positioning guide 20. The clinician may use the osteogenic guide 30 to guide an osteogenic instrument, such as a cutting blade, to form an end of the first metatarsal 210 and the opposing end of the medial cuneiform 222. The clinician may form one or both ends of the bone before and / or after engaging the osteogenic guide 20 to move the first metatarsal 210 in at least one plane, such as the transverse and / or frontal planes.

[0034] 5A and 5B (collectively referred to as FIG. 5) are perspective and top views, respectively, of an exemplary configuration of a biplanar instrument 10. As shown in this example, the instrument 10 includes a spacer body 12 coupled to a fulcrum body 14. In some examples, the spacer body 12 and the fulcrum body 14 are intersecting body members coupled together without an intervening coupling member. In other examples, such as the example shown in FIG. 5, an intermediate coupling member 16 joins the spacer body 12 to the fulcrum body 14.

[0035] The coupling member 16 may be in the form of a bridge extending between the spacer body 12 and the fulcrum body 14. In use, the spacer body 12 may be configured to extend in the frontal plane of the foot between the first metatarsal 210 and the medial cuneiform 222. The fulcrum body 14 may be configured to extend in the sagittal plane of the foot between the first metatarsal 210 and the medial metatarsal 212. The bridge member 16 may define a curved and / or angled region of the biplanar instrument 10 that transitions from the frontal plane to the sagittal plane. For example, the bridge member may be configured to extend from the proximal side of the first metatarsal 210 to the lateral side of the metatarsal. By coupling the spacer body 12 to the fulcrum body 14 via the bridge member 16, the position and orientation of the two bodies relative to each other and / or relative to the first metatarsal 210 may be fixed. This may help ensure proper positioning of each body during use.

[0036] In general, the spacer body 12 may define a length configured to be inserted into a joint space, a thickness configured to extend between the bones (metatarsal and opposing cuneiform) that define the joint space, and a width configured to extend in a medial-to-lateral direction across a portion or all of the joint space. The spacer body 12 may define a first portion 40 configured to extend at least partially into the joint space between the metatarsal and opposing cuneiform, and a second portion 42 configured to extend over the joint space. The second portion 42 may be configured to engage a receiving cavity of an osteogenic guide or may be integrally attached to the osteogenic guide.

[0037] The fulcrum body 14 may define a length configured to be inserted within the intermetatarsal space, a thickness configured to extend between the first metatarsal bone 210 and the second metatarsal bone 212, and a width configured to extend in a proximal to distal direction across the foot. The thickness of the fulcrum body 14 may taper toward the front end to facilitate insertion of the fulcrum body 14 into the space between adjacent metatarsals.

[0038] In some examples, the instrument 10 includes a handle 44. The handle 44 may be connected to and extend from the spacer body 12 in addition to or instead of the fulcrum body 14, but is shown as operably connected to the fulcrum body 14. The handle 44 may be any structure projecting proximally from the biplanar instrument 10 (e.g., from the fulcrum body 14) that may provide a gripping location for the instrument during use. In some examples, such as the example shown in FIG. 5, the handle 44 may project at an angle away from the fulcrum body 14 to define a tissue retraction space. The tissue retraction space may be an area bounded on one side by the fulcrum body 14 and one side of the handle 44. In use, the body fulcrum 14 may be inserted into the intermetatarsal space with the handle 44 extending out of the surgical incision and onto the epidermal layer where tissue is captured in the tissue retraction space. For example, the fulcrum body 14 may be inserted into the intermetatarsal space with the handle 44 protruding toward the lateral side of the foot being manipulated. The tissue retraction space may serve to retract tissue and push tissue laterally away from the first metatarsal and / or medial cuneiform bone being manipulated.

[0039] To form the tissue retraction space, the handle 44 may project away from the fulcrum body 14, e.g., linearly at a zero degree angle and / or laterally at a non-zero degree angle. The particular angular orientation of the handle 44 relative to the body 14 may vary. However, in some instances, the handle 44 is oriented relative to the fulcrum body 14 so that the handle axis intersects with an axis extending along the length of the fulcrum body at an acute angle ranging from 5 degrees to 85 degrees, such as 20 degrees to 75 degrees, or 35 degrees to 55 degrees.

[0040] In general, the biplanar instrument 10 may be fabricated from any suitable material. In different examples, the instrument may be fabricated from metal, polymeric material, or hybrid forms of multiple metals and / or polymeric materials. In addition, although the spacer body 12 and the fulcrum body 14 are illustrated as having a generally rectangular cross-sectional shape, one or both bodies may define a different generally polygonal cross-sectional shape (e.g., square, hexagonal) and / or a generally arcuate cross-sectional shape (e.g., circular, elliptical).

[0041] For example, the spacer body 12 and / or the fulcrum body 14 may define a planar bone-contacting surface, although one or both bodies may alternatively have a non-planar bone-contacting surface. Figures 5C and 5D are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of the fulcrum body 14 that defines a concave bone-contacting surface. Figures 5E and 5F are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of the fulcrum body 14 that defines a convex bone-contacting surface.

[0042] As yet another example, the fulcrum body 14 of the biplanar instrument 10 may be angled in the sagittal plane, for example, such that the plantar end of the fulcrum body extends further medially than the dorsal end of the fulcrum body, or alternatively, such that the plantar end of the fulcrum body extends further laterally than the dorsal end of the fulcrum body. Angling the fulcrum body 14 in the sagittal plane may be useful, for example, to help dorsiflex or plantarflex a displaced metatarsal by providing an angled fulcrum surface that tends to reorient the metatarsal in the sagittal plane. The above discussion of exemplary fulcrum body shapes and / or profile configurations may be used in stand-alone fulcrum devices in the techniques described herein (e.g., without the use of an attached spacer body).

[0043] In some examples, the biplanar instrument 10 (e.g., spacer body 12, fulcrum body 14, bridge member 16) are formed as a unitary structure, for example, by milling, casting, or molding the components so that they are permanently and structurally integrated together. In other examples, one or more features may be fabricated as separate components that are later joined together.

[0044] In some examples, the biplanar instrument 10 is used as part of a metatarsal realignment procedure in which the metatarsal is realigned relative to adjacent cuneiforms and / or metatarsals in one or more planes, such as two or three planes. Additional details regarding examples of bone realignment techniques and devices in which the instrument 10 may be used are described in U.S. Patent No. 9,622,805, filed December 28, 2015 and issued April 18, 2017, entitled "BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS," U.S. Patent No. 9,936,994, filed July 14, 2016 and issued April 10, 2018, entitled "BONE POSITIONING GUIDE," and U.S. Patent Publication No. 2017 / 0042599, filed August 14, 2016, entitled "TARSAL-METATARSAL JOINT PROCEDURE UTILIZING FULCRUM." The entire contents of each of these documents are incorporated herein by reference.

[0045] 6A and 6B (collectively referred to as FIG. 6) are perspective and top views, respectively, illustrating an exemplary osteogenic guide 30 that may be used as part of a surgical procedure involving a biplanar instrument 10. In some examples, the osteogenic guide 30 includes a body 32 that defines a first guide surface 34 for defining a first formation surface, and a second guide surface 36 for defining a second formation surface. A tissue removal instrument (e.g., a saw, rotary burr, osteotome, etc., not shown) can be aligned with the surface to remove tissue (e.g., remove cartilage or bone and / or cut bone). The first and second guide surfaces 34, 36 can be spaced apart from one another by a distance (e.g., about 2 millimeters to about 10 millimeters, e.g., about 4 to about 7 millimeters). In different configurations, the first and second guide surfaces can be parallel to one another or angled with respect to one another, such that cuts on adjacent bones using the guide surfaces will generally be parallel to one another or angled.

[0046] In some configurations, the first and second guide surfaces 34, 36 are bounded by opposing surfaces to define guide slots. Each slot may be sized to receive a tissue removal instrument for forming the bone apophysis. In either case, an opening 38 may be defined in the body 32 of the osteogenic guide 30 to receive the spacer body 12. In use, a clinician may insert the biplanar instrument 10 into the joint space between the first metatarsal 210 and the medial cuneiform 222 and between the first metatarsal 210 and the second metatarsal 212. The clinician may then insert the osteogenic guide 30 into the spacer body 12 of the instrument, for example, by aligning the opening 38 with a portion of the spacer body 12 that protrudes dorsally from the joint space. Alternatively, as described above, the osteogenic guide 30 and the biplanar instrument 10 may be pre-assembled (e.g., removably coupled together or permanently and fixedly joined together) such that inserting the biplanar instrument 10 into the joint space between adjacent bones simultaneously positions the osteogenic guide 30 over one or more bones to be formed.

[0047] In the example shown, the osteogenic guide 30 extends from a first end positioned over the first metatarsal bone 210 and a second end positioned over the medial cuneiform bone 222. One or both ends of the body may define one or more fixation apertures configured to receive fixation pins for anchoring the osteogenic guide 30 to one or more bones.

[0048] The bone formation facilitated by the osteogenic guide 30 may be useful, for example, to facilitate contact between the leading edges of adjacent bones separated by a joint, or different portions of a single bone separated by a fracture, such as in bone alignment and / or fusion procedures. The bone may be formed using one or more osteogenic techniques. In some applications, the bone is formed by cutting the bone. The bone may be cut transversely to establish a new epiphysis facing the opposing bone portion. Additionally or alternatively, the bone may be formed by morselizing the end of the bone. The epiphysis may be morselized using any suitable tool, such as a rotary burr, osteotome, drill, etc. The epiphysis may be morselized by grinding, drilling, crushing, pulping, and / or breaking the epiphysis into small pieces to facilitate deformable contact with the opposing bone portion.

[0049] During a surgical technique utilizing the biplanar instrument 10, a bone may be moved from an anatomically misaligned position to an anatomically aligned position relative to another bone. Additionally, both the end of the moved bone and the opposing end of the adjacent end may be prepared for fixation. In some applications, at least one end of the moved bone and / or the other bone is prepared after moving the bone to the aligned position. In other applications, at least one end of the moved bone and / or the other bone is prepared prior to moving the bone to the aligned position. In still other applications, one and the other ends of the moved bone are prepared prior to moving the bone to the aligned position, while the opposite facing end of the bone (either the moved bone or the other bone) is prepared after moving the bone to the aligned position.

[0050] Movement of one bone relative to another bone can be accomplished using one or more instruments and / or techniques. In some instances, bone movement is accomplished using a bone positioning device that applies a force to one bone through one or more moving components, translating and / or rotating the bone in response to the force, for example. This can be accomplished using a bone positioning guide that includes a bone engaging member, a tip, a mechanism that urges the bone engaging member and tip toward one another, and an actuator that actuates the mechanism. Additionally or alternatively, bone movement can be accomplished using a compression distractor by imparting movement of one bone relative to another bone when the compression distractor is positioned over substantially parallel pins, moving the pins from their substantially parallel alignment, resulting in movement of the underlying bone in one plane (e.g., frontal, sagittal, transverse), two or more planes, or all three planes. Additionally or alternatively, the clinician can facilitate movement by physically grasping the bone, either by direct contact with the bone or indirectly (e.g., inserting a K-wire, grasping with the tenaculum, etc.) and moving their hand to move the bone.

[0051] In use, the clinician may insert the biplanar instrument 10 between the first metatarsal 210 and the second metatarsal 212, and between the first metatarsal 210 and the medial cuneiform 222 (or other adjacent bones when not performing a first metatarsal realignment) at any time before moving the first metatarsal (e.g., by actuating a bone positioning guide or otherwise manipulating the bones). In one embodiment, the clinician forms the joints being manipulated to release soft tissue and / or resect plantar inflammation from the base of the first metatarsal 210. Before or after placing the optional bone positioning guides on the adjacent bones, the clinician inserts the instrument 10 into the joints between the first metatarsal and the second metatarsal, and between the first metatarsal and the medial cuneiform. The clinician may then actuate the bone positioning guides 20 (e.g., if used). The distal portion of the first metatarsal may be moved in the transverse plane toward the second metatarsal to close the IMA, thereby pivoting the proximal portion of the first metatarsal about the fulcrum body 14 and reducing the IMA between the first and second metatarsals. Use of the fulcrum body 14 may minimize or eliminate base compression between the adjacent bones being manipulated.

[0052] The clinician may additionally engage the osteogenic guide 30 with the spacer body 12 and use the osteogenic guide to form the ends of the first metatarsal 210 and the medial cuneiform 222. The clinician may form the ends of one or both bones (e.g., using the osteogenic guide 30) before or after moving the first metatarsal in one or more planes. In either case, the clinician may optionally provisionally fix (e.g., by inserting k-wires or other fixation elements) the moved positions to the first metatarsal 210 and adjacent bones (e.g., the second metatarsal 212, the medial cuneiform 222). The clinician may, for example, remove the bone positioning guide 20 and the biplanar instrument 10 from the foot before or after the optional provisional fixation. In either case, the clinician may permanently fix the formed epiphysis to fuse the formed epiphysis together.

[0053] In one exemplary technique, after conventional surgical preparation and access, a bone preparation instrument can be inserted into the joint (e.g., the first tarsometatarsal joint) to free soft tissue and / or resect the plantar ligament from the base of the first metatarsal 210. Removing the plantar ligament can involve severing the plantar ligament from the first metatarsal 210 so that the face of the first metatarsal is generally flat. This step helps to shift the joint to facilitate correction of the deformity. In some embodiments, the dorsolateral ligament of the first metatarsal can also be resected to create space for deformity correction (e.g., relative to the rotation of the first metatarsal). In certain embodiments, the portion of the metatarsal base facing the medial cuneiform can be removed during this shifting step.

[0054] An incision can be made and, if a bone locating instrument is used, one end (e.g., the tip) of bone locating guide 20 is inserted on the lateral side of a metatarsal bone other than first metatarsal bone 210, such as second metatarsal bone 212. The tip can be positioned proximal to the base of second metatarsal bone 212 and the third metatarsal bone 294 interface.

[0055] The clinician may insert the biplanar instrument 10 into the joint before or after attaching the optional bone positioning guide 20. The clinician may position the spacer body 12 in the joint space between the first metatarsal 210 and the medial cuneiform 222 while simultaneously positioning the fulcrum body 14 in the joint space between the first metatarsal 210 and the second metatarsal 212.

[0056] When the biplanar instrument 10 includes a bridge member 16, the bridge member may be positioned in contact with the proximal lateral angle of the first metatarsal 210 to help properly position the spacer body 12 and the fulcrum body 14 relative to one another. For example, the bridge member 16 may position the spacer body 12 substantially in the center, or lateral half, of the joint space between the first metatarsal 210 and the medial cuneiform 222. The bridge member 16 may further position the fulcrum body 14 in a notch between the first metatarsal 210 and the second metatarsal 212 at the base of the metatarsals (e.g., adjacent respective cuneiforms). The fulcrum body 14 may provide a point about which the first metatarsal 210 may rotate and / or pivot while helping to minimize or avoid base compression between the first metatarsal and the second metatarsal.

[0057] In applications utilizing bone positioning guide 20, one or more movable features of the bone positioning guide may be moved to reduce the angle (transverse plane angle between the first and second metatarsals) and rotate the first metatarsal about its axis (frontal plane axis rotation). The first metatarsal 210 may be properly positioned relative to the medial cuneiform 222 by moving the bone engaging member of the bone positioning guide 20 relative to the tip of the bone positioning guide 20. In some embodiments, such movement simultaneously pivots the first metatarsal relative to the cuneiform and rotates the first metatarsal about its longitudinal axis to an anatomically correct position to correct the transverse plane deformity and the frontal plane deformity. Other instrumented and / or non-instrumented approaches may be used to adjust the position of the first metatarsal 210 relative to the medial cuneiform 222. Thus, other applications utilizing the biplanar instrument 10 may be implemented without utilizing bone positioning guide 20 and / or without using bone positioning guides having designs different from the specific examples shown herein.

[0058] Regardless of whether a bone positioning guide 20 is used, an exemplary technique may include positioning an osteogenic guide 30 on the spacer body 12 (if the osteogenic guide is not integral with the spacer body), as shown in FIG. 6 . A portion of the spacer body 12 that protrudes dorsally from the joint space between the first metatarsal 210 and the medial cuneiform 222 may be received within an opening 38 of the osteogenic guide 30. One or more fixation pins may be inserted into the openings of the osteogenic guide 30 to secure the guide to the first metatarsal 210 and the medial cuneiform 222. When the osteogenic guide 30 is pre-assembled with the biplanar instrument 10 (e.g., removably coupled thereto or fixedly and permanently coupled thereto), insertion of the biplanar instrument 10 into the joint space may simultaneously position one or more guide surfaces of the osteogenic guide 30 on one or more bone surfaces to be formed (e.g., cut) using the guide surfaces.

[0059] In some applications, the end of the first metatarsal 210 facing the medial cuneiform 222 can be formed with a tissue removal instrument guided by the guide surface of the bone formation guide 30 (e.g., inserted through a slot defined by the first guide surface and the first facing surface). In some embodiments, the end formation of the first metatarsal 210 occurs after at least partially aligning the bone, e.g., by actuating the bone positioning guide 20 or otherwise moving the first metatarsal, but after forming the end of the first metatarsal 210. In other embodiments, the end formation of the first metatarsal 210 occurs prior to alignment of the bone.

[0060] In addition to forming the end of the first metatarsal 210, the end of the medial cuneiform 222 facing the first metatarsal 210 can be formed with a tissue removal tool guided by the guide surface of the osteogenic guide 30 (e.g., inserted through a slot defined by the second guide surface and the second opposing surface). In some embodiments, the end formation of the medial cuneiform 222 occurs after the bones are aligned. In still other embodiments, the end formation of the medial cuneiform 222 occurs before the bones are aligned. In embodiments that include cutting bone or cartilage, the cuneiform cut and the metatarsal cut can be parallel, coincident cuts, or the cuts can be angled relative to one another. In some examples, a saw blade can be inserted through a first slot to cut a portion of the medial cuneiform and a saw blade can be inserted through a second slot to cut a portion of the first metatarsal.

[0061] When the osteogenic guide 30 is separable from the biplanar instrument 10, any angled / converging pins may be removed and the osteogenic guide 30 may be lifted off the substantially parallel first and second pins similarly inserted into the bone (or all fixation pins may be removed). The biplanar instrument 10 (or at least the spacer body 12 of the instrument) may be removed from the foot. In some instances, the compression distractor is positioned downward over the parallel pins that remain in the bone or are otherwise attached to the bone.

[0062] In applications in which the bone positioning guide 20 is utilized, the bone positioning guide may be removed before or after the osteogenic guide 30 is removed and a compression distractor, if used, is placed. In either case, in some instances, a temporary fixation device such as an olive pin, k-wire, or other fixation structure may be used to maintain the position of the underlying bone (e.g., the first metatarsal 210 relative to the medial cuneiform 222) while, for example, the osteogenic guide 30 is removed and, optionally, a compression distractor is placed, and / or during permanent fixation.

[0063] When the compression distractors are pinned to the underlying bones (e.g., the first metatarsal 210 and medial cuneiform 222), the compression distractors can be actuated to distract the underlying bones. With the underlying bones distracted, the clinician can clean or otherwise form the space between the bones and / or the end faces of one or both bones. The clinician can clean the space by removing excess cartilage, bone, and / or other cellular debris that may have been originally present or that may have been created during the bone formation step that may have inhibited the injectate.

[0064] Regardless of whether the clinician utilizes the compression distractor 100 to distract the underlying bone for cleaning, the clinician may engage the compression distractor to compress the first metatarsal toward the medial cuneiform bone.

[0065] With the end faces pressed together (optionally via actuation of a compression distractor), the clinician may temporarily and / or permanently fix the bones or bone portions together. One or more bone fixation devices, such as two bone plates positioned in different planes, may be applied to the two bones across the joint to stabilize the joint for fusion. For example, a first bone plate may be positioned on the dorsal medial side of the first metatarsal and medial cuneiform, and a second bone plate may be positioned on the medial plantar side of the first metatarsal and medial cuneiform. In some embodiments, the bone plate used for fixation may be a spiral bone plate positioned on the plantar side of the first metatarsal across the joint space from the medial side of the cuneiform. The plates may be applied by inserting bone screws. Examples of bone plates that can be used as first bone plate 310 and / or second bone plate 320 are described in U.S. Patent Publication No. 2016 / 0192970, filed January 7, 2016, entitled "Bone Plating System and Method," which is incorporated herein by reference. Other types of bone fixation device configurations can be used, and the disclosure is not limited in this respect. For example, intramedullary pins or nails can be used in addition to or in place of bone plates.

[0066] The spacer body 12 and fulcrum body 14 of the biplanar instrument 10 may be permanently bonded together (e.g., such that the spacer bodies cannot be separated from one another without permanently destroying or altering the device). Alternatively, the spacer body 12 may be removably connected to the fulcrum body 14. Such a configuration may allow the spacer body 12 to be removed from the joint space while the fulcrum body 14 remains within the joint space (or other separation measures are implemented), or vice versa.

[0067] In one embodiment, for example, a clinician may insert the biplanar instrument 10 into the joint space and then realign one bone relative to another. As the bones are realigned relative to one another, the fulcrum body 14 provides a surface along which adjacent bones may slide and / or prevent compression or proximal shift between adjacent bones during realignment. After realigning the bones relative to one another, the clinician may remove the spacer body 12 from the fulcrum body 14, leaving the spacer body 12 in the joint space. An osteogenic guide 30 may then be placed on the spacer body 12 to facilitate formation of one or both bones.

[0068] As another example, a clinician may insert a biplanar instrument 10 into the joint space and then insert an osteogenic guide 30 onto the spacer body 12 of the biplanar instrument 10 (if the osteogenic guide and instrument are installed separately). The clinician may then use the osteogenic guide 30 to prepare the end faces of one or both bones prior to subsequent realignment. Once the end faces of one or both bones are suitably prepared, the clinician may remove the osteogenic guide 30 and detach the spacer body 12 from the fulcrum body 14. The spacer body 12 may then be removed from the joint space, leaving the fulcrum body 14 between the adjacent bones for subsequent bone realignment.

[0069] 7A and 7B are perspective and top views, respectively, of an exemplary configuration of the biplanar instrument 10 in which the spacer body 12 is removable from and attachable to the fulcrum body 14. In this example, the bridge member 16 is permanently attached to the spacer body 12 and defines an insertion end that is insertable into a corresponding receiving portion of the fulcrum body 14. The spacer body 12 and bridge member 16 may be removed from the fulcrum body 14 by sliding the spacer body and bridge member longitudinally (e.g., dorsally when inserted into the foot), allowing the spacer body and bridge member to be removed from the fulcrum body.

[0070] In other configurations, the bridge member 16 may be attachable to and detachable from the spacer body 12 in addition to or instead of being attachable to and detachable from the fulcrum body 14. In still other configurations, the biplanar instrument 10 may not include a bridge member, but may instead be comprised of the spacer body 12 connected directly to the fulcrum body 14. In these configurations, the spacer body 12 and the fulcrum body 14 may have corresponding connections that allow the two bodies to be attachable and detachable from one another. In general, any features described as being removably coupled to one another (e.g., attachable and detachable) may have complementary connecting features (e.g., corresponding male and female connecting features, corresponding magnetic features) that allow the features to be selectively joined together and separated from one another.

[0071] Whether or not the spacer body 12 and the fulcrum body 14 are detachable from one another, the biplanar instrument 10 may position two different bodies joined to one another. The relative angle between the spacer body 12 and the fulcrum body 14 may vary depending on the desired application (e.g., the anatomical location in which the biplanar instrument 10 is intended to be inserted and / or the anatomy of the particular patient in which the biplanar instrument 10 will be used). In some examples, the biplanar instrument 10 defines an included angle between the spacer body 12 and the fulcrum body 14 (with or without the bridge member 16) ranging from 60 degrees to 120 degrees, e.g., 80 degrees to 100 degrees, or about 90 degrees. The angle between the spacer body 12 and the fulcrum body 14 may be fixed (such that the angle is not intended to be adjustable or manipulable by the clinician during use) or may be variable (such that the angle may be adjusted by the clinician within the surgical site prior to insertion and / or while inserted into a patient undergoing the procedure in which the instrument will be used).

[0072] In some examples, the angle between the spacer body 12 and the fulcrum body 14 is defined by a steepness, e.g., where the spacer body intersects with the fulcrum body at an angle defined therebetween. In other examples, the biplanar instrument 10 defines a radius of curvature transitioning between the spacer body 12 and the fulcrum body 14, and the angle of intersection is defined between the faces of the two bodies. For example, in the examples shown in Figures 5B and 7B, the biplanar instrument 10 is shown as having a radius of curvature between the spacer body 12 and the fulcrum body 14. Configuring the biplanar instrument 10 with a curved transition between the spacer body 12 and the fulcrum body 14 (at least on the back side of the instrument) can be useful to provide a smooth surface to aid in inserting the instrument into the patient, e.g., by minimizing sharp edges that may catch on the patient's tissue during insertion.

[0073] When the biplanar instrument 10 is configured with a fixed angle between the spacer body 12 and the fulcrum body 14, the instrument may be made of a material, and have a material thickness, effective to substantially prevent a clinician from changing the angle between the two bodies during use of the instrument. Similarly, instructions for use accompanying the biplanar instrument 10 may indicate that the instrument is intended to be used without manipulating the angle between the spacer body 12 and the fulcrum body 14.

[0074] In other configurations, the angle between the spacer body 12 and the fulcrum body 14 may be adjustable by a clinician. For example, the instructions for use accompanying the biplanar instrument 10 may indicate that a clinician may adjust the position of the spacer body 12 and the fulcrum body 14 relative to one another before and / or after inserting the instrument into a patient. In one example, the biplanar instrument 10 may be fabricated of a material and have a material thickness effective to allow a clinician to change the angle between the spacer body 12 and the fulcrum body 14 during use. For example, the biplanar instrument 10 (e.g., bridge member 16 of the instrument) may be fabricated of a malleable metal and / or polymeric material that a clinician may manipulate under hand pressure (e.g., with or without the assistance of an instrument such as a bending tool) to change the angle between the spacer body 12 and the fulcrum body 14.

[0075] Additionally or alternatively, the biplanar instrument 10 may include one or more flexible joints (e.g., rotational joints) that allow the angular position of the spacer body 12 to be adjusted relative to the fulcrum body 14. As one example, the spacer body 12 may be operably connected to the fulcrum body 14 via one or more cables, allowing the angular orientation of the spacer body 12 and the fulcrum body 14 to be changed by bending the one or more cables. As another example, the spacer body 12 may be operably connected to the fulcrum body 14 via a hinge connection, allowing the spacer body and the fulcrum body to rotate relative to one another about the hinge.

[0076] 8A and 8B are front and rear perspective views, respectively, of an exemplary configuration of a biplanar instrument 10, in which the instrument is configured with a hinge connection 50 between the spacer body 12 and the fulcrum body 14. In the configuration shown, the spacer body 12 is directly connected to the fulcrum body 14 via the hinge 50. In other embodiments, the spacer body 12 may be hingedly or fixedly connected to a bridge member 16, which is then connected to the fulcrum body 14 with or without a hinge connection (e.g., a hinged or fixed connection). Configuring the biplanar instrument 10 with a hinge connection 50 may be beneficial to allow the spacer body 12 to rotate relative to the fulcrum body 14, allowing the relative angle between the two components to be adjusted.

[0077] In use, the clinician may adjust the angle between the spacer body 12 and the fulcrum body 14 before, during, and / or after insertion into the patient's joint space. This may allow the angle between the spacer body 12 and the fulcrum body 14 to be adjusted based on the needs of the condition being treated and / or the particular anatomy of the patient undergoing the procedure. The clinician may rotate the spacer body 12 and the fulcrum body 14 relative to one another about the hinge 50 before and / or after preparing one or both end faces of the bones that define the joint space into which the spacer body 12 is inserted, as described above.

[0078] In some configurations, the spacer body 12 and the fulcrum body 14 may rotate relative to one another for an unlimited range of rotations (e.g., from a first position where the inner surface of the spacer body 12 contacts the inner surface of the fulcrum body 14 to a second position where the outer surface of the spacer body contacts the outer surface of the fulcrum body). In other configurations, the spacer body 12 and the fulcrum body 14 may rotate relative to one another within a limited range of rotations. For example, the biplanar instrument 10 may include one or more rotation stops that limit the degree of rotation between the spacer body 12 and the fulcrum body 14.

[0079] Figures 9A-9D show exemplary relative rotational positions between the spacer body 12 and the fulcrum body 14 of the biplanar instrument 10. Figure 9A shows the spacer body 12 extending perpendicularly (at a +90 degree angle) relative to the fulcrum body 14. Figure 9B shows the spacer body 12 positioned at an acute angle relative to the fulcrum body 14. Figure 9C shows the spacer body 12 positioned at an obtuse angle relative to the fulcrum body 14. Additionally, Figure 9D shows the spacer body 12 extending in the opposite perpendicular direction (at a -90 degree angle) relative to the fulcrum body 14.

[0080] As shown in Figures 9A-9D, the spacer body 12 may be configured to rotate through an arc of rotation greater than 90 degrees, such as an arc of rotation of at least 180 degrees. For example, the spacer body 12 may rotate relative to the fulcrum body 14 about an axis of rotation defined by a hinge 50 that defines an angle of at least +45 degrees relative to the fulcrum body 14 to -45 degrees relative to the fulcrum body. As a result, the positions of the spacer body 12 and the fulcrum body 14 may be reversible. This may be useful to allow a single instrument 10 to be used on both the right and left feet of a patient. The position of the spacer body 12 may rotate (e.g., about 180 degrees) depending on whether the instrument 10 is intended to be used on the right or left foot.

[0081] As discussed above, the biplanar instrument 10 includes a spacer body 12. The spacer body 12 may be sized and shaped to be positioned in a space between two bone portions, such as a joint space between adjacent bones (e.g., the TMT joint between the metatarsal and cuneiform bones). The spacer body 12 may include a first portion insertable into the space between the adjacent bone portions and a second portion that protrudes above the space between the bone portions. The second portion that protrudes above the space may be coupled to a surgical instrument, such as an osteogenic guide, to control positioning of the surgical instrument on the bone portions that define the space into which the spacer body 12 is inserted.

[0082] To engage a surgical instrument (described below with reference to osteogenic guide 30 for purposes of discussion) with the spacer body 12, the surgical instrument may have a receiving opening configured to receive a portion of the spacer body 12 that protrudes above the joint space into which the spacer body is inserted. Thus, the receiving opening and the spacer body may be sized and shaped relative to one another to allow the spacer body to be inserted into and / or through the receiving opening of the surgical instrument. In some configurations, the receiving opening of the surgical instrument is sized to match the size of the spacer body 12 to be inserted therein (e.g., such that once the spacer body is inserted into the surgical instrument, there is little or no relative movement between the spacer body and the surgical instrument). In other configurations, the surgical instrument may be sized to allow relative movement between the spacer body and the surgical instrument even once the spacer body is inserted into the receiving opening of the surgical instrument.

[0083] 10A-10C illustrate an exemplary system including a biplanar instrument 10 and an osteogenic guide 30, where the osteogenic guide is configured to move relative to the spacer body of the biplanar instrument. Figures 10A and 10B are perspective and top views, respectively, showing the spacer body 12 of the biplanar instrument 10 inserted into the receiving opening 38 of the osteogenic guide 30 in a first position. Figure 10C is a top view showing the spacer body 12 of the biplanar instrument 10 inserted into the receiving opening 38 of the osteogenic guide 30 in a second position moved in the transverse plane relative to the first position.

[0084] As shown in the example of Figures 10A-10C, the opening 38 of the osteogenic guide 30 is sized larger in one or more dimensions (e.g., only one) than the portion of the spacer body 12 received therein. In particular, in the example shown, the opening 38 of the osteogenic guide 30 is sized to facilitate linear movement of the osteogenic guide 30 relative to the spacer body 12 in the transverse plane when placed, for example, on a TMT joint. The opening 38 of the osteogenic guide 30 has an area 52 that is longer than the length of the spacer body 12 inserted within the opening. As a result, the osteogenic guide 30 can slide relative to the spacer body 12 while the spacer body protrudes upward through the opening. This can be useful to allow the clinician to reposition one or more guide surfaces 34, 36 of the osteogenic guide relative to one or more bone apices to be formed once the osteogenic guide is placed on the spacer body inserted into the joint space.

[0085] 10A and 10B show the osteogenic guide 30 translated to its most lateral side (when positioned on the foot) so that the area 52 of the opening 38 larger than the spacer body 12 is located on the outside of the spacer body. FIG. 10C shows the osteogenic guide 30 translated to its most medial side (when positioned on the foot) so that the area 52 of the opening 38 larger than the spacer body 12 is located on the inside of the spacer body. The clinician may also move the osteogenic guide 30 to one or more intermediate positions within the area 52 of the opening 38 larger than the spacer body 12 that is split between the medial and lateral sides of the spacer body 12.

[0086] In some configurations, the opening 38 is sized relative to the size of the spacer body 12 such that the osteogenic guide may translate a distance of at least 0.5 mm relative to the spacer body 12, e.g., at least 1 mm, at least 2 mm, or at least 5 mm. For example, the opening 38 may be sized relative to the portion of the spacer body 12 received therein to be 0.5 mm to 25 mm longer than the length of the spacer body, e.g., 1 mm to 10 mm longer. This may allow for 0.5 mm to 25 mm of relative movement, e.g., 1 mm to 10 mm of relative movement, between the osteogenic guide and the spacer body. When the osteogenic guide 30 is placed on the TMT joint, the osteogenic guide may be translated relative to the spacer body 12 in the transverse plane (medial to lateral direction) by utilizing the extra length of the opening 38 relative to the size of the spacer body.

[0087] In some examples, the openings 38 of the osteogenic guide 30 are configured (e.g., sized and / or shaped) relative to the spacer body 12 to allow relative movement between the osteogenic guide and the spacer body in the coronal and / or sagittal planes in addition to or instead of allowing relative movement in the transverse plane. In other examples, the spacer body 12 and the osteogenic guide 30 are configured to prevent movement relative to one another in one or more planes. The spacer body 12 and the osteogenic guide 30 can be configured to prevent movement relative to one another in one or more planes by sizing and / or shaping two features relative to one another to prevent or limit movement in one or more planes.

[0088] With further reference to Figures 8A and 8B, the biplanar instrument 10 is shown to include a shelf 54 that projects outwardly from the remainder of the spacer body 12. The shelf 54 can be an area of ​​increased thickness compared to the remainder of the spacer body 12. The shelf 54 can extend outwardly from one side of the spacer body (e.g., the anterior side) or multiple sides of the spacer body (e.g., the anterior and posterior sides) as shown in the example of Figures 8A and 8B. The shelf 54 can be located on a portion of the spacer body that is insertable into the joint space between adjacent bones. In other words, the shelf 54 can be located on a portion of the spacer body 12 that is insertable into the opening 38 of the osteogenic guide 30. By configuring the spacer body 12 with the shelf 54, the increased thickness of the spacer body 12 in the area of ​​the shelf 54 can prevent or eliminate relative movement between the spacer body and the osteogenic guide in the frontal and / or sagittal planes (when placed on the foot). As a result, the osteogenic guide 30 can translate relative to the spacer body 12 in the transverse plane, but can be in a substantially fixed orientation relative to the spacer body in the frontal and / or sagittal planes.

[0089] 8A and 8B, the biplanar instrument 10 is also illustrated as having a protrusion 56 extending outwardly from one or both sides of the spacer body 12. The protrusion 56 may form a bull's eye (e.g., an X-shaped or T-shaped intersection) when the spacer body 12 is viewed from above. This may be useful when visualizing the spacer body 12 under fluoroscopy to help the clinician interpret where the spacer body is located within the joint space and / or relative to the osteogenic guide 30.

[0090] Although the biplanar instrument 10 has been generally described as being useful for insertion into the space between opposing bone ends that transition into the intermetatarsal space, the instrument may be used in any desired application, and the disclosure is not limited in this respect. For example, the biplanar instrument 10 may be positioned between different bone portions and / or inserted into a different joint space than those explicitly discussed above. Additionally, although the biplanar instrument 10 has been generally described as having a spacer body 12 configured to be positioned in a first joint space and a fulcrum body 14 configured to be positioned in a second joint space that intersects with and is angled relative to the first joint space, the biplanar instrument may be used with only one of the spacer body 12 and the fulcrum body 14 positioned in a joint space (and / or positioned between different bone portions).

[0091] As one exemplary application, the biplanar instrument 10 may be utilized in a total ankle replacement procedure. One body (e.g., spacer body 12 or fulcrum body 14) may be inserted between the talus and tibia in the coronal plane and parallel to the frontal plane. The other body may be inserted between the tibia and talus in the medial sagittal plane or between the fibula and talus on the lateral side.

[0092] As another exemplary application, the biplanar instrument 10 may be utilized in a total knee replacement procedure. One body (e.g., spacer body 12 or fulcrum body 14) may be inserted between the tibia and femur, and the other body may be positioned around either the medial or lateral condyle of the femur or the tibial plateau of the tibia to align the cutting guide with the axis of the femur or tibia.

[0093] As yet a further exemplary application, the biplanar instrument 10 may be utilized in a total elbow replacement procedure. For either the ulna or radius resection, one body (e.g., spacer body 12 or fulcrum body 14) may be inserted between the ulna and humerus. The other body may be positioned around either the medial or lateral side of the bone (ulna or humerus) to set the angle of the cut for either bone.

[0094] Various embodiments have been described. These and other embodiments are within the scope of the following claims. [Configuration 1] 1. A biplanar instrument for bone cutting and joint realignment procedures, comprising: a spacer body configured to be inserted into a joint space between a metatarsal bone and an opposing cuneiform bone of the foot; a fulcrum body coupled to a spacer body, the fulcrum body configured to be inserted within an intermetatarsal space between a metatarsal bone and an adjacent metatarsal bone. [Configuration 2] the spacer body defines a length configured to be inserted into the joint space, a thickness configured to extend between the metatarsal and the opposing cuneiform bone, and a width configured to extend in a medial-lateral direction across at least a portion of the joint space; 2. The apparatus of configuration 1, wherein the fulcrum body defines a length configured to be inserted within the intermetatarsal space, a thickness configured to extend between the metatarsal bone and the adjacent metatarsal bone, and a width configured to extend in a proximal to distal direction along the foot. [Configuration 3] 3. The apparatus of any one of the preceding claims, further comprising a bridge extending between the spacer body and the fulcrum body, the fulcrum body being coupled to the spacer body via the bridge. [Configuration 4] 4. The apparatus of configuration 3, wherein the spacer body is configured to extend in a first plane of the foot, the fulcrum body is configured to extend in a second plane of the foot, and the bridge member transitions from the first plane to the second plane. [Configuration 5] 5. The device of any one of configurations 3 to 4, wherein the bridge member is configured to extend from a proximal side of the metatarsal to a lateral side of the metatarsal. [Configuration 6] 6. The apparatus of any one of configurations 1-5, wherein the angle defined between the spacer body and the fulcrum body is in the range of 60 degrees to 120 degrees. [Configuration 7] 7. The device of any one of configurations 1-6, wherein the spacer body is fixedly connected to the fulcrum body. [Configuration 8] 8. The device of any one of configurations 1-7, wherein the spacer body is hingedly connected to the spacer body. [Configuration 9] 9. The apparatus of configuration 8, wherein the spacer body is configured to rotate at least 180 degrees relative to the fulcrum body to facilitate use on both right and left feet. [Configuration 10] 10. The device of any one of configurations 1-9, wherein the spacer body is removably connected to the fulcrum body. [Configuration 11] 11. The instrument of any one of configurations 1-10, wherein the spacer body defines a first portion configured to extend into the joint space between the metatarsal and the opposing cuneiform bone and a second portion configured to extend over the joint space, the second portion configured to engage a receiving opening of an osteotomy guide. [Configuration 12] 12. The instrument of claim 11, wherein the osteogenic guide defines at least one cutting slot configured to be positioned on the metatarsal bone, the at least one cutting slot configured to be positioned on the opposing cuneiform bone. [Configuration 13] 13. The instrument of any one of configurations 11-12, wherein the second portion of the spacer body is sized smaller than the receiving opening of the osteogenic guide such that when the spacer body is inserted into the receiving opening, the osteogenic guide can move in at least one plane relative to the spacer body. [Configuration 14] 14. The instrument of claim 13, wherein the second portion of the spacer body further comprises a shelf extending outwardly from at least one of the anterior and posterior surfaces of the spacer body, the shelf limiting movement between the osteogenic guide and the spacer body. [Configuration 15] 15. The apparatus of any one of claims 1 to 14, further comprising an osteogenic guide permanently attached to the spacer body. [Configuration 16] 16. The instrument of any one of configurations 1-15, further comprising a handle connected to the fulcrum body, the handle projecting away from the fulcrum body. [Configuration 17] the metatarsal bone is a first metatarsal bone, the opposing cuneiform bone is a medial cuneiform bone; 17. The device of any one of embodiments 1-16, wherein the adjacent metatarsal is a second metatarsal. [Configuration 18] 1. A method comprising: inserting a spacer body into a joint space between a metatarsal bone and an opposing cuneiform bone; inserting a fulcrum body coupled to the spacer body between the metatarsal bone and an adjacent metatarsal bone; using an osteogenic guide aligned with the spacer to guide an osteogenic instrument to form the end of the metatarsal bone; using the osteogenic guide to guide the osteogenic instrument to form the opposing cuneiform bone ends; and moving the metatarsal bone relative to the adjacent metatarsal bone in at least a transverse plane, thereby pivoting the metatarsal bone about the fulcrum body and reducing the intermetatarsal angle between the metatarsal bone and the adjacent metatarsal bone. [Configuration 19] 20. The method of claim 18, wherein the spacer body is coupled to the fulcrum body with a bridge member. [Configuration 20] 20. The method of claim 19, wherein inserting the spacer body and inserting the fulcrum body comprises inserting a unitary instrument including the spacer body coupled to the fulcrum body via the bridge member. [Configuration 21] 21. The method of claim 20, wherein inserting the single instrument includes positioning the bridge member relative to a proximal lateral angle of the metatarsal. [Configuration 22] 22. The method according to any one of aspects 18 to 21, wherein the spacer body is fixedly connected to the fulcrum body. [Configuration 23] 23. The method of any one of aspects 18-22, wherein the angle defined between the spacer body and the fulcrum body is in the range of 60 degrees to 120 degrees. [Configuration 24] 25. The method of any one of aspects 18-24, further comprising adjusting an angle defined between the spacer body and the fulcrum body. [Configuration 25] 25. The method of claim 24, wherein the spacer body is hinged to the fulcrum body, and adjusting the angle defined between the spacer body and the fulcrum body includes rotating the spacer body relative to the fulcrum body about a hinge connection. [Configuration 26] 25. The method of claim 24, wherein adjusting the angle defined between the spacer body and the fulcrum body comprises bending a malleable section of material connecting the spacer body to the fulcrum body. [Configuration 27] 27. The method of any one of configurations 18-26, wherein inserting the spacer body into the joint space comprises inserting a first portion of the spacer body into the joint space with a second portion of the spacer body extending over the joint space, and further comprising aligning the osteogenic guide with the second portion of the spacer body. [Configuration 28] 28. The method of claim 27, wherein the second portion of the spacer body is sized smaller than a receiving opening of the osteogenic guide into which the second portion of the spacer body is inserted, and further comprising moving the osteogenic guide relative to the spacer body in at least one plane while the spacer body is inserted into the receiving opening. [Configuration 29] 29. The method of claim 28, wherein the second portion of the spacer body further comprises a shelf extending outwardly from at least one of the anterior and posterior surfaces of the spacer body, the shelf limiting movement between the osteogenic guide and the spacer body. [Configuration 30] 30. The method of any one of aspects 18-29, wherein the osteogenic guide is permanently connected to the spacer body, and inserting the spacer body into the joint space includes positioning the osteogenic guide over the metatarsal and the opposing cuneiform bone. [Configuration 31] 31. The method of any one of configurations 18-30, further comprising a handle protruding at a non-zero angle away from the fulcrum body, and wherein inserting the fulcrum body further comprises retracting tissue laterally away from an incision providing access to the metatarsal and the adjacent metatarsal, and holding the tissue away from the incision in a tissue retraction space formed between the handle and the fulcrum body. [Configuration 32] the metatarsal bone is a first metatarsal bone, the opposing cuneiform bone is a medial cuneiform bone; 32. The method of any one of aspects 18 to 31, wherein the adjacent metatarsal is a second metatarsal. [Configuration 33] 33. The method of any one of configurations 18-32, further comprising removing at least the spacer body from the joint space; compressing the formed end of the metatarsal bone against the formed end of the opposing cuneiform bone; and fixing the formed end of the metatarsal bone to the formed end of the opposing cuneiform bone. [Configuration 34] 34. The method of claim 33, wherein removing at least the spacer body further comprises removing the fulcrum body coupled to the spacer body. [Configuration 35] 35. The method of any one of aspects 18-34, wherein fixing the formed end of the metatarsal bone to the formed end of the opposing cuneiform bone includes inserting a fixation member across the tarsometatarsal joint. [Configuration 36] 36. The method of any one of aspects 18-35, wherein forming the end of the metatarsal bone and forming the end of the opposing cuneiform bone comprises forming one or both of the end of the metatarsal bone and the end of the opposing cuneiform bone after moving the metatarsal bone relative to the adjacent metatarsal bone.

Claims

1. 1. A biplanar instrument for bone cutting and joint realignment procedures, comprising: a spacer body configured to be inserted into a joint space between a metatarsal bone and an opposing cuneiform bone of the foot; a fulcrum body coupled to a spacer body, the fulcrum body configured to be inserted within an intermetatarsal space between a metatarsal bone and an adjacent metatarsal bone.

2. the spacer body defines a length configured to be inserted into the joint space, a thickness configured to extend between the metatarsal and the opposing cuneiform bone, and a width configured to extend in a medial-lateral direction across at least a portion of the joint space; 10. The device of claim 1, wherein the fulcrum body defines a length configured to be inserted into the intermetatarsal space, a thickness configured to extend between the metatarsal bone and the adjacent metatarsal bone, and a width configured to extend in a proximal to distal direction along the foot.

3. 3. The device of claim 1 or 2, further comprising a bridge member extending between the spacer body and the fulcrum body, the fulcrum body being coupled to the spacer body via the bridge member.

4. 4. The apparatus of claim 3, wherein the spacer body is configured to extend in a first plane of the foot, the fulcrum body is configured to extend in a second plane of the foot, and the bridge member transitions from the first plane to the second plane.

5. The device of claim 3 or 4, wherein the bridge member is configured to extend from a proximal side of the metatarsal to a lateral side of the metatarsal.

6. The device of any one of claims 1 to 5, wherein the angle defined between the spacer body and the fulcrum body is in the range of 60 degrees to 120 degrees.

7. The device of any one of claims 1 to 6, wherein the spacer body is fixedly connected to the fulcrum body.

8. The device of any one of claims 1 to 7, wherein the spacer body is hingedly connected to the fulcrum body.

9. 9. The device of claim 8, wherein the spacer body is configured to rotate at least 180 degrees relative to the fulcrum body to facilitate use on both right and left feet.

10. The device of any one of claims 1 to 9, wherein the spacer body is removably connected to the fulcrum body.

11. 11. The instrument of any one of claims 1-10, wherein the spacer body defines a first portion configured to extend into the joint space between the metatarsal bone and the opposing cuneiform bone and a second portion configured to extend over the joint space, the second portion configured to engage a receiving opening of an osteogenic guide.

12. 12. The instrument of claim 11, wherein the osteogenic guide defines at least one cutting slot configured to be positioned on the metatarsal bone, the at least one cutting slot configured to be positioned on the opposing cuneiform bone.

13. 13. The instrument of claim 11 or 12, wherein the second portion of the spacer body is sized smaller than the receiving opening of the osteogenic guide such that, with the spacer body inserted within the receiving opening, the osteogenic guide can move in at least one plane relative to the spacer body.

14. 14. The instrument of claim 13, wherein the second portion of the spacer body further comprises a shelf extending outwardly from at least one of an anterior and posterior surface of the spacer body, the shelf limiting movement between the osteogenic guide and the spacer body.

15. The device of any one of claims 1 to 14, further comprising an osteogenic guide permanently joined to the spacer body.

16. An instrument according to any preceding claim, further comprising a handle connected to the fulcrum body, the handle projecting away from the fulcrum body.

17. the metatarsal bone is a first metatarsal bone, the opposing cuneiform bones are medial cuneiform bones; The device of any one of claims 1 to 16, wherein the adjacent metatarsal is a second metatarsal.

Images