Two-plane instrument for bone cutting and joint realignment procedures

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 osteotomy and / or realignment techniques.

Background Art

[0003] Bones in the human body, such as the bones of the foot, may be anatomically misaligned. For example, one common type of bone deformity is hallux valgus, which is a progressive foot deformity that affects the first metatarsophalangeal joint and often involves significant functional impairment and foot pain. The metatarsophalangeal joint is displaced medially, with the first metatarsal bone rotating laterally while the phalanx rotates medially. This often leads to soft tissue development and a bony prominence on the inside of the foot called hallux valgus.

[0004] Surgical intervention may be used to correct hallux valgus deformity. There are various different surgical procedures for correcting hallux valgus deformity, which may involve removing abnormal bone enlargement of the first metatarsal bone and / or attempting to realign the first metatarsal bone with respect to adjacent metatarsal bones. Surgical instruments that can facilitate efficient, accurate, and reproducible clinical outcomes are useful to the practitioner performing bone realignment techniques.

Summary of the Invention

[0005] Generally, the present disclosure is directed to an instrument that can be used during surgical osteotomy and / or realignment procedures. The instrument may include a spacer body connected to a fulcrum body. The spacer body and the fulcrum body may be positionable within adjacent joint spaces, and a connecting member between the spacer body and the fulcrum body serves to control the relative positions of the spacer body and the fulcrum body when inserted within their respective joint spaces.

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

[0007] The device also includes a pivot body coupled to a spacer body. The pivot 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 and second metatarsal bone. The pivot body may define a pivot point, or pivot surface, around which the metatarsal bones can rotate to realign their positions relative to opposing cuneiform bones and / or adjacent metatarsals. For example, the pivot body may define a pivot surface around which the proximal base of the metatarsal bones can pivot when the intermetatarsal angle between the metatarsal bone and the adjacent metatarsal bone is closed. This may help prevent the base of the metatarsal bones from shifting laterally, such as by compression relative to the adjacent metatarsal bones, when the metatarsal bones are realigned.

[0008] In some configurations, the spacer body is connected to the pivot body using a bridge member. The bridge member can transition from one plane in which the spacer body is positioned (e.g., generally the frontal plane) to a second plane in which the pivot body is positioned (e.g., generally the sagittal plane). For example, the bridge member can define an angle (e.g., in the range of 60 to 120 degrees, e.g., 80 to 100 degrees, or having an interior angle of about 90 degrees) that movably connects the spacer body to the pivot body. During use, the bridge member can be positioned relative to the angles of the realigned metatarsals, such as the proximal transverse angle / surface of the metatarsals. When positioned in this manner, the spacer body can be positioned within the articular space between the metatarsal and the opposing cuneiform bone, while the pivot body can be positioned within the articular space between the metatarsal and the adjacent metatarsal bone. The bridge member may help 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 surgical procedures. This may help ensure that the spacer body and the fulcrum body are properly positioned for subsequent procedural steps performed using the spacer body and the fulcrum body (e.g., performing an osteoplasty step using an osteoplasty guide attached to the spacer body, and / or realigning the metatarsals by pivoting around the fulcrum body).

[0009] One example describes a two-plane instrument for bone cutting and joint realignment procedures. The instrument includes a spacer body configured to be inserted into the articular space between the metatarsal bones of the foot and the opposing cuneiform bones. The instrument also includes a pivot body coupled to the spacer body, the pivot body configured to be inserted into the intermetatarsal space between the metatarsal bones and the adjacent metatarsal bones.

[0010] Another example describes a method comprising inserting a spacer body into the articular space between a metatarsal bone and an opposing cuneiform bone. The method also comprises inserting a fulcrum body coupled to the spacer between a metatarsal bone and an adjacent metatarsal bone. The method further involves using a bone formation guide aligned with the spacer to guide a bone formation instrument to form the end of the metatarsal bone, and using a bone formation guide to guide the bone formation instrument to form the end of the opposing cuneiform bone. In addition, the method comprises moving the metatarsal bone relative to the adjacent metatarsal bone, at least in cross-section, thereby rotating the metatarsal bone around the fulcrum body and reducing the intermetatarsal angle between the metatarsal bone and the adjacent metatarsal bone.

[0011] Details of one or more embodiments are described in the accompanying drawings and the following description. Other features, purposes, and advantages will become apparent from the specification and drawings, as well as the claims. [Brief explanation of the drawing]

[0012] [Figure 1A] Figures 1A and 1B are frontal views of the foot showing the normal position of the first metatarsal bone and an exemplary frontal plane rotational displacement position, respectively. [Figure 1B] Figures 1A and 1B are frontal views of the foot showing the normal position of the first metatarsal bone and an exemplary frontal plane rotational displacement position, respectively. [Figure 2A] Figures 2A and 2B are top views of the foot showing the normal position of the first metatarsal bone and an exemplary cross-sectional displacement position, respectively. [Figure 2B] Figures 2A and 2B are top views of the foot showing the normal position of the first metatarsal bone and an exemplary cross-sectional displacement position, respectively. [Figure 3A] Figures 3A and 3B are lateral views of the foot showing the normal position of the first metatarsal bone and an exemplary sagittal displacement position, respectively. [Figure 3B] Figures 3A and 3B are lateral views of the foot showing the normal position of the first metatarsal bone and an exemplary sagittal displacement position, respectively. [Figure 4A]Figures 4A and 4B are perspective and top views, respectively, of an exemplary bone positioning operation in which a two-plane instrument is positioned within a first articular space and an intersecting second articular space. [Figure 4B] Figures 4A and 4B are perspective and top views, respectively, of an exemplary bone positioning operation in which a two-plane instrument is positioned within a first articular space and an intersecting second articular space. [Figure 5A] Figures 5A and 5B are perspective and top views, respectively, of exemplary configurations of the two-plane apparatus shown in Figures 4A and 4B. [Figure 5B] Figures 5A and 5B are perspective and top views, respectively, of exemplary configurations of the two-plane apparatus shown in Figures 4A and 4B. [Figure 5C] Figures 5C and 5D are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a concave bone contact surface. [Figure 5D] Figures 5C and 5D are perspective and cross-sectional views, respectively, illustrating an exemplary configuration of a fulcrum body defining a concave bone contact surface. [Figure 5E] Figures 5E and 5F are perspective and cross-sectional views, respectively, illustrating exemplary configurations of the support body defining the convex bone contact surface. [Figure 5F] Figures 5E and 5F are perspective and cross-sectional views, respectively, illustrating exemplary configurations of the support body defining the convex bone contact surface. [Figure 6A] Figures 6A and 6B are perspective and top views, respectively, illustrating an exemplary bone formation guide that may be used as part of a surgical procedure involving two-plane instruments. [Figure 6B] Figures 6A and 6B are perspective and top views, respectively, illustrating an exemplary bone formation guide that may be used as part of a surgical procedure involving two-plane instruments. [Figure 7A] Figures 7A and 7B are perspective and top views, respectively, of exemplary configurations of a two-plane fixture in which the spacer body is detachable from and attachable to the pivot body. [Figure 7B]Figures 7A and 7B are perspective and top views, respectively, of an exemplary configuration of a two-plane instrument where the spacer body is removable from and attachable to the fulcrum body. [Figure 8A] Figures 8A and 8B are front and rear perspective views, respectively, of an exemplary configuration of a two-plane instrument configured with a hinge connection. [Figure 8B] Figures 8A and 8B are front and rear perspective views, respectively, of an exemplary configuration of a two-plane instrument configured with a hinge connection. [Figure 9A] Figures 9A - 9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary two-plane instrument shown in Figures 8A and 8B. [Figure 9B] Figures 9A - 9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary two-plane instrument shown in Figures 8A and 8B. [Figure 9C] Figures 9A - 9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary two-plane instrument shown in Figures 8A and 8B. [Figure 9D] Figures 9A - 9D show exemplary relative rotational positions between the spacer body and the fulcrum body for the exemplary two-plane instrument shown in Figures 8A and 8B. [Figure 10A] Figures 10A - 10C show an exemplary system including a two-plane instrument and a bone formation guide, where the bone formation guide is sized to move relative to the spacer body of the two-plane instrument. [Figure 10B] Figures 10A - 10C show an exemplary system including a two-plane instrument and a bone formation guide, where the bone formation guide is sized to move relative to the spacer body of the two-plane instrument. [Figure 10C] Figures 10A - 10C show an exemplary system including a two-plane instrument and a bone formation guide, where the bone formation guide is sized to move relative to the spacer body of the two-plane instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In general, this disclosure relates to devices including spacer bodies and fulcrum bodies that may be used in surgical procedures such as bone realignment procedures. Exemplary procedures in which fulcrum structures 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 compared to the bones of other parts of the anatomical structure of the human body, for example, bones of the foot or hand (e.g., adjacent bones separated by a joint or different parts of a single bone). In one example, a procedure utilizing a device including two bodies joined together by a bridge member may be performed to correct the alignment between a metatarsal bone (e.g., the first metatarsal bone) and a second metatarsal bone and / or a cuneiform bone (e.g., the medial or first cuneiform bone), such as in hallux valgus correction surgery. An example of such a procedure is the Rapidus procedure (also known as the first tarsal-metatarsal fusion). While the exemplary instruments described herein are generally described as being useful for insertion into the space between opposing epiphysis, transitioning into the intermetatarsal space, the instruments may be used for any desired application, and the disclosure is not limited in this respect.

[0014] Figures 1–3 are different views of foot 200 showing exemplary anatomical misalignments that occur in accordance with this disclosure and can be corrected using fulcrums. Such misalignments may be caused by hallux valgus (bunion), a natural growth deformity, or other conditions that cause anatomical misalignment. Figures 1A and 1B are frontal views of foot 200 showing the normal first metatarsal position and an exemplary frontal plane rotational misalignment position, respectively. Figures 2A and 2B are top views of foot 200 showing the normal first metatarsal position and an exemplary cross-sectional misalignment position, respectively. Figures 3A and 3B are lateral views of foot 200 showing the normal first metatarsal position and an exemplary sagittal plane misalignment position, respectively. Although Figures 1B, 2B, and 3B each show the misalignment in their respective planes individually, in practice, the metatarsal may be misaligned in any two of the three planes, or all three planes. Therefore, please understand that the depictions of single-plane displacements in Figures 1B, 2B, and 3B are for illustrative purposes only, and that metatarsals may have displacements in multiple planes, which are preferably corrected.

[0015] Referring to Figures 1A and 2A, the foot 200 is composed of several bones, including the first metatarsal 210, the second metatarsal 212, the third metatarsal 214, the fourth metatarsal 216, and the fifth metatarsal 218. The metatarsals are distally connected to the phalanges 220, and more specifically, each is connected to its respective proximal phalanx. The first metatarsal 210 is proximal to the medial cuneiform 222, the second metatarsal 212 is proximal to the intermediate cuneiform 224, and the third metatarsal is proximal to the lateral cuneiform 226. The fourth and fifth metatarsals 216 and 218 are proximal to the cuboid 228. The joint 230 between the metatarsal bone and each cuneiform bone (e.g., the first metatarsal bone 210 and the medial cuneiform bone 222) is called the tarsometatarsal (TMT) joint. The joint 232 between the metatarsal bone and each proximal phalanx is called the metatarsophalangeal joint. The angle 234 between adjacent metatarsal bones (e.g., the first metatarsal bone 210 and the second metatarsal bone 212) is called the intermetatarsal angle (IMA).

[0016] As previously mentioned, Figure 1A is a frontal plane view of the foot 200 showing the typical position of the first metatarsal bone 210. The frontal plane, also known as the coronal plane, is generally considered to be an arbitrary 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 proximal to distal along the length of the foot. Figure 1A shows the first metatarsal bone 210 in a typical rotational position in the frontal plane. Figure 1B shows the first metatarsal bone 210 with a frontal plane rotational deformation characterized by a rotation angle 236 relative to the ground, as indicated by line 238.

[0017] Figure 2A is a top view of the foot 200 showing the typical position of the first metatarsal bone 210 in cross-section. A cross-section, also known as the horizontal plane, axial plane, or body axial cross-section, is considered any plane that divides the body into an upper and lower part. In the foot 200, the cross-section is a plane that extends horizontally and is perpendicular to an axis that extends across the foot from dorsally to plantarly (top to bottom). Figure 2A shows the first metatarsal bone 210 with a typical IMA 234 in cross-section. Figure 2B shows the first metatarsal bone 210 with a cross-sectional rotational deformation characterized by a larger IMA caused by the medial rotation of the distal end of the first metatarsal bone 210 relative to the second metatarsal bone 212.

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

[0019] The two-plane device according to this disclosure may define a spacer body extending from medial to lateral (e.g., parallel to the frontal plane) of the foot, which is coupled to a fulcrum body extending from proximal to distal (e.g., parallel to the sagittal plane) of the foot. A connecting member may connect the spacer body to the fulcrum body and transition from the frontal plane to the sagittal plane. In some examples, the connecting member may coincide with (e.g., contact) areas of the metatarsal bones that are also being realigned to the proximal end faces of the metatarsal bones and the lateral proximal ends of the metatarsal bones. The two-plane device may be used as part of a bone positioning technique to correct anatomical misalignment of one or more bones. In some applications, the technique involves realigning the metatarsal bones relative to adjacent cuneiform bones and / or adjacent metatarsal bones. The metatarsal bones being realigned may be anatomically misaligned in the frontal, transverse, and / or sagittal planes, as illustrated and discussed with respect to Figures 1 to 3 above. Therefore, realignment may involve freeing the displaced metatarsal bones or a portion thereof for realignment, and then realigning the metatarsal bones in one or more planes, two or more planes, or all three planes. After the metatarsal bones have been suitably realigned, they can be fixed to hold and maintain the realigned position.

[0020] The metatarsals can have various anatomically aligned and misaligned positions, but in some cases, the term “anatomically aligned position” means that the angle between the long axis of the first metatarsal 210 and the long axis of the second metatarsal 212 is about 10 degrees or less in the transverse and / or sagittal planes. In certain embodiments, 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 to about 13 degrees is considered a mild misalignment of the first and second metatarsals. An IMA 234 greater than about 16 degrees is considered a severe misalignment of the first and second metatarsals.

[0021] In some applications, the two-plane instrument is used as part of a realignment technique to anatomically align the first metatarsal bone 210 or a portion thereof by positioning the first metatarsal bone at different angles relative to the second metatarsal bone, reducing the IMA from more than 10 degrees to about 10 degrees or less (e.g., an IMA of about 1 to 5 degrees), including negative angles of about -5 degrees or until interference with the second metatarsal bone.

[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 bones are generally parallel to the ground and positioned below the metatarsal bone. This position can be defined as a 0-degree metatarsal rotation. In a displaced first metatarsal, the metatarsal rotates axially by approximately 4 degrees to approximately 30 degrees or more. In some embodiments, a two-plane instrument is used as part of a realignment technique to anatomically align the metatarsal bones by rotating the metatarsal bones relative to the medial cuneiform bones, thereby reducing the metatarsal rotation from approximately 4 degrees or more to less than 4 degrees (e.g., approximately 0 to 2 degrees).

[0023] The two-plane instrument defining a spacer body coupled to a pivot body according to this disclosure may be useful in providing a single structure (e.g., before and after assembly) that can be positioned between two adjacent intersecting articular spaces: a first articular space between the opposing ends of metatarsal and cuneiform bones, and an intermetatarsal space between adjacent metatarsal bones. The spacer body may include a first portion insertable into the articular space and a second portion projecting above the articular space. The second portion projecting above the articular space is coupled to an osteogenic guide, thereby facilitating the positioning of the osteogenic guide on the metatarsal and / or cuneiform bones between which the spacer body is positioned. The pivot body can establish and / or maintain space between adjacent moved bones, preventing lateral translation or base shift of the bones during rotation and / or pivoting.

[0024] For example, a two-plane device may include a spacer body that can be positioned within the articular space between a first metatarsal bone 210 and a medial cuneiform bone 222. The spacer body may be coupled to an osteogenic guide. The osteogenic guide includes a receptive slot into which the protruding end of the spacer body is positioned, thereby allowing the osteogenic guide to be oriented toward the articular 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 bone 210 and / or the end of the medial cuneiform bone that will be cut, such as at least one metatarsal cutting slot positioned on the end of the first metatarsal bone 210 that will be cut, and at least one cuneiform cutting slot positioned on the end of the medial cuneiform bone 222 that will be cut.

[0025] The two-plane device may also include a pivot body that can be positioned within the articular space between the first metatarsal bone 210 and the second metatarsal bone 212. The pivot body may be inserted into the notch between the first metatarsal bone 210 and the second metatarsal bone 212 at the base of the metatarsal bones (e.g., each adjacent cuneiform bone) before moving the first metatarsal bone, for example, to help prevent the most proximal base of the first metatarsal bone 210 from shifting toward the second most proximal base 212. The pivot body may provide a point around which the first metatarsal bone 210 can rotate and / or pivot, while helping to minimize or avoid base compression between the first and second metatarsal bones. In addition, using the pivot body allows the first metatarsal bone 210 and the medial cuneiform bone 222 to be at a better angle with respect to the guide slot (of the osteogenic guide engaged with the spacer body) positioned on the end face of the bone, providing a better cutting angle through the guide slot than when the pivot body is not used. This may help reduce or eliminate unwanted springback or return positioning of the first metatarsal bone 210 after the initial realignment of the metatarsals.

[0026] Figures 4A and 4B (collectively referred to as Figure 4) are perspective and top views, respectively, of an exemplary bone positioning operation in which the two-plane instrument 10 is positioned within a first articular space and an intersecting second articular space, with the bones forming the first and second articular spaces being realigned relative to one or more adjacent bones. In particular, Figure 4 shows the two-plane instrument 10 having a spacer body 12 connected to a fulcrum body 14 via a connecting or bridge member 16. The spacer body 12 is positioned at the intersection between the end of the first metatarsal bone 210 and the opposing medial cuneiform bone 222. The fulcrum body 14 is positioned between the first metatarsal bone 210 and the second metatarsal bone 212. The two-plane instrument 10 may optionally be used in combination with other surgical devices, such as a bone positioning guide 20 and an osteoplasty guide 30 (Figure 6). Additional details relating to exemplary bone positioning guides, bone formation guides, and related technologies are described in U.S. Patent Application No. 14 / 981,335 filed December 28, 2015, and U.S. Patent Application No. 15 / 236,464 filed August 14, 2016, the entire contents of which are incorporated herein by reference.

[0027] As shown in the example in Figure 4, the spacer body 12 may be positioned between the opposing ends of adjacent bones, such as the opposing ends of a metatarsal bone (e.g., a first metatarsal bone 210) and a cuneiform bone (e.g., a medial cuneiform bone 222) separated by an articular space. The spacer body 12 may define a length configured to be inserted into the articular space between the two bones (e.g., at least a portion of the body protrudes dorsally above the articular space), a thickness configured to extend between the metatarsal bone and the opposing cuneiform bone (e.g., the first metatarsal bone 210 and the medial cuneiform bone 222 are in contact with the opposite side of the spacer body), and a width configured to extend medially to laterally across the foot.

[0028] The spacer body 12 can be positioned at any suitable location across the articular space (e.g., anteriorly). Specific positioning of the spacer body 12 in use can be established by the bridge member 16 coupled to the pivot body 14. For example, when the two-plane device 10 is inserted into the articular space, the bridge member 16 may contact the proximal transverse angle or region of the first metatarsal bone 210. This can limit the range to which the spacer body 12 can shift medially across the articular space and help to fix the spacer body in a medial-to-lateral direction (e.g., in the frontal plane). In other examples, the two-plane device 10 can be inserted into the articular space without the angle defined by the bridge member 16 contacting the bone (e.g., the first metatarsal bone).

[0029] Although not shown in Figure 4, in different examples, the spacer body 12 may be engageable with and detachable from the osteoplasty guide 30, or it may be integral with the osteoplasty guide (for example, permanently coupled). The positioning of the spacer body 12 in the joint space may define the positioning of the osteoplasty guide 30 coupled to it, and, correspondingly, the guiding of the osteoplasty instrument facilitated by the osteoplasty guide.

[0030] The two-plane device 10 also includes a pivot body 14. The pivot body 14 may be positioned distal to the bone positioning guide 20 between the first metatarsal bone 210 and the second metatarsal bone 212, or, in other applications, distal to the guide. As shown, the pivot body 14 of the two-plane device 10 is shown proximal to the bone positioning guide 20, and the pivot body is positioned within the articular space between the first and second metatarsal bones (for example, at the ends of the first and second metatarsal bones abutting the medial and intermediate cuneiform bones, respectively). In yet another example, the pivot body 14 may be positioned within the intermetatarsal space between the first metatarsal bone 210 and the second metatarsal bone 212 without using the bone positioning guide 20 and / or the bone formation guide 30 (Figure 6).

[0031] During use, the clinician may insert the pivot body 16 between the first metatarsal bone 210 and the second metatarsal bone 212 at any point before moving the first metatarsal bone (e.g., by activating the bone positioning guide 20 or by other means of manipulating the bone). In one embodiment, the clinician forms the joint being manipulated in order to release soft tissue and / or to excise plantar inflammation from the base of the first metatarsal bone 210. Either before or after placing the bone positioning guide 20 on the adjacent bone, the clinician inserts the two-plane instrument 10 into the joint space. The clinician may insert the spacer body 12 into the joint space between the first metatarsal bone 210 and the medial cuneiform bone 222, and may also insert the pivot body 14 into the joint space between the first metatarsal bone 210 and the second metatarsal bone 212.

[0032] After inserting the two-plane instrument 10, the clinician can activate the bone positioning guide 20. In the case of the left foot as shown in Figure 4, the activation of the bone positioning guide 20 rotates the first metatarsal bone 210 counterclockwise in the frontal plane (from the patient's perspective) and also rotates it in the transverse plane around the pivot body. In the case of the right foot (not shown), the activation rotates the first metatarsal bone clockwise in the frontal plane (from the patient's perspective) and also rotates it in the transverse plane around the pivot body. Therefore, for both feet, the activation of the bone positioning guide 20 can supinate the first metatarsal bone in the frontal plane and rotate the first metatarsal bone in the transverse plane around the pivot body 14.

[0033] Before or after activating the bone positioning guide 20 (if used), the clinician may engage the osteoplasty guide with a portion of the spacer body 12 that protrudes from the articular space between the first metatarsal bone 210 and the medial cuneiform bone 222. The spacer body 12 may have a length that is effective for engaging the osteoplasty guide with it. In some embodiments, after inserting the two-plane instrument 10 into the articular space, the clinician places a separate, removable osteoplasty guide 30 on the spacer body 12. The clinician may install the osteoplasty guide 30 before or after installing the bone positioning guide 20. The clinician may use the osteoplasty guide 30 to guide an osteoplasty instrument, such as a cutting blade, to form the end of the first metatarsal bone 210 and the opposing end of the medial cuneiform bone 222. The clinician may move the first metatarsal bone 210 in at least one plane, such as the transverse plane and / or frontal plane, by forming one or both ends of the bone before and / or after engaging the osteoplasty guide 20.

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

[0035] The connecting member 16 may take the form of a bridge extending between the spacer body 12 and the pivot body 14. During use, the spacer body 12 may be configured to extend in the frontal plane of the foot between the first metatarsal bone 210 and the medial cuneiform bone 222. The pivot body 14 may be configured to extend in the sagittal plane of the foot between the first metatarsal bone 210 and the medial metatarsal bone 212. The bridge member 16 may define the curved and / or angled region of the two-plane device 10 transitioning 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 bone 210 to the lateral side of the metatarsal bone. By connecting the spacer body 12 to the pivot 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 bone 210 can be fixed. This may help ensure proper positioning of each body during use.

[0036] Generally, the spacer body 12 may have a length configured to be inserted into the articular space, a thickness configured to extend between the bones defining the articular space (between the metatarsal bone and the opposing cuneiform bone), and a width configured to extend medially to laterally across part or all of the articular space. The spacer body 12 may have a first portion 40 configured to extend at least partially into the articular space between the metatarsal bone and the opposing cuneiform bone, and a second portion 42 configured to extend over the articular space. The second portion 42 may be configured to engage with the receiving cavity of the osteogenic guide, or may be integrally attached to the osteogenic guide.

[0037] The pivot body 14 may have a defined length configured to be inserted into 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 proximal to distal across the foot. The thickness of the pivot body 14 may taper towards the anterior end to facilitate insertion of the pivot 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 a spacer body 12 in addition to, or instead of, the pivot body 14, but is shown as being operably connected to the pivot body 14. The handle 44 may be any structure that protrudes proximally from the two-plane instrument 10 (e.g., from the pivot body 14) and can provide a gripping place for the instrument during use. In some examples, such as the example shown in Figure 5, the handle 44 may protrude at an angle away from the pivot body 14 to define a tissue retraction space. The tissue retraction space may be an area demarcated on one side by the pivot body 14 and one side of the handle 44. During use, the body pivot 14 may be inserted into the intermetatarsal space with the handle 44 extending out of the surgical incision over the epidermal layer in which the tissue is trapped within the tissue retraction space. For example, the pivot body 14 may be inserted into the intermetatarsal space with the handle 44 protruding laterally toward the foot being operated on. The tissue dissection space may help to dissect the tissue and push it laterally away from the first metatarsal and / or medial cuneiform bone being operated on.

[0039] To form a tissue opening space, the handle 44 may protrude away from the pivot body 14, for example, linearly at a zero-degree angle and / or laterally at a non-zero-degree angle. The specific angular orientation of the handle 44 relative to the body 14 may vary. However, in some examples, the handle 44 is oriented relative to the pivot body 14 so that the handle axis intersects the axis extending along the length of the pivot body at an acute angle in the range of 5 to 85 degrees, such as 20 to 75 degrees or 35 to 55 degrees.

[0040] In general, the two-plane fixture 10 can be made from any suitable material. In different examples, the fixture may be made from metal, polymer material, or a hybrid of multiple metals and / or polymer material. In addition, although the spacer body 12 and the support body 14 are generally exemplified as having a rectangular cross-sectional shape, one or both bodies may define different substantially polygonal cross-sectional shapes (e.g., square, hexagonal) and / or substantially arcuate cross-sectional shapes (e.g., circular, elliptical).

[0041] For example, the spacer body 12 and / or the pivot body 14 may define a plane that contacts the bone, while one or both bodies may alternatively have a non-plane that contacts the bone. Figures 5C and 5D are perspective and cross-sectional views, respectively, showing exemplary configurations of the pivot body 14 defining a concave bone contact surface. Figures 5E and 5F are perspective and cross-sectional views, respectively, showing exemplary configurations of the pivot body 14 defining a convex bone contact surface.

[0042] As yet another example, the pivot body 14 of the two-plane device 10 may be angled in the sagittal plane, for example, such that the plantar end of the pivot body extends further inward than the dorsal end of the pivot body, or alternatively, such that the plantar end of the pivot body extends further outward than the dorsal end of the pivot body. Angling the pivot body 14 in the sagittal plane may be useful, for example, to assist in dorsiflexion or plantarflexion of a displaced metatarsal by providing an angled pivot surface that tends to reorient the metatarsal bones in the sagittal plane. The above discussion of exemplary pivot body shapes and / or external configurations may be used in standalone pivot devices in the art described herein (e.g., without using an attached spacer body).

[0043] In some examples, the two-plane fixture 10 (e.g., spacer body 12, pivot body 14, bridge member 16) is formed as a single 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 manufactured as separate components that are later joined together.

[0044] In some cases, the two-plane instrument 10 is used as part of a metatarsal realignment procedure in which the metatarsals are realigned relative to adjacent cuneiform 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, titled "BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS," filed December 28, 2015, and issued April 18, 2017; U.S. Patent No. 9,936,994, titled "BONE POSITIONING GUIDE," filed July 14, 2016, and issued April 10, 2018; and U.S. Patent Publication No. 2017 / 0042599, titled "TARSAL-METATARSAL JOINT PROCEDURE UTILIZING FULCRUM," filed August 14, 2016. The entire contents of each of these documents are incorporated herein by reference.

[0045] Figures 6A and 6B (collectively referred to as Figure 6) are perspective and top views, respectively, of an exemplary osteoplasty guide 30 that may be used as part of a surgical procedure with a two-plane instrument 10. In some examples, the osteoplasty guide 30 includes a body 32 defining a first guide surface 34 for defining a first plasty surface and a second guide surface 36 for defining a second plasty surface. Tissue removal instruments (e.g., saws, rotary burs, osteotomes, etc., not shown) can be aligned on 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 each other by a certain distance (e.g., about 2 mm to about 10 mm, e.g., about 4 to about 7 mm). In different configurations, the first and second guide surfaces may be parallel to each other or angled relative to each other, thereby so that cuts to adjacent bones using the guide surfaces are generally parallel to each other or angled relative to each other.

[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 epiphysis. In any case, an opening 38 may be defined within the body 32 of the osteoplasty guide 30 to receive the spacer body 12. During use, the clinician may insert the two-plane instrument 10 into the articular space between the first metatarsal bone 210 and the medial cuneiform bone 222, and between the first metatarsal bone 210 and the second metatarsal bone 212. The clinician may then insert the osteoplasty 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 articular space. Alternatively, as described above, the bone formation guide 30 and the double-plane instrument 10 may be pre-assembled such that inserting the double-plane instrument 10 into the articular space between adjacent bones simultaneously positions the bone formation guide 30 on one or more bones to be formed (for example, they may be removably joined together or permanently and fixedly joined together).

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

[0048] Osteogenesis facilitated by the osteoplasty guide 30 may be useful to facilitate contact between different parts of a single bone separated by a fracture, for example, at the anterior edges of adjacent bones separated by a joint, or in bone alignment and / or fusion procedures. Bone can be formed using one or more osteoplasty techniques. In some applications, bone is formed by cutting the bone. The bone can be cut transversely to establish a new epiphysis facing the opposite bone portion. Additionally or alternatively, bone may be formed by fragmenting the end of the bone. The epiphysis can be fragmented using any suitable tool such as a rotary bur, osteotome, or drill. The epiphysis can be fragmented by grinding, puncturing, crushing, pulping, and / or breaking it into small fragments to facilitate deformable contact with the opposing bone portion.

[0049] During surgical procedures utilizing the two-plane instrument 10, bones can be moved from an anatomically misaligned position to an anatomically aligned position relative to another bone. Furthermore, both the end of the moved bone and the opposing end of the adjacent end can be formed for fixation. In some applications, at least one end of the moved bone and / or other bones is formed after the bone has been moved to the aligned position. In other applications, at least one end of the moved bone and / or other bones is formed before the bone has been moved to the aligned position. In yet another application, one and the other ends of the moved bone are formed before the bone has been moved to the aligned position, but the end of the bone facing the opposite side (either the moved bone or the other bone) is formed after the bone has been moved to the aligned position.

[0050] The movement of one bone relative to another can be achieved using one or more instruments and / or techniques. In some examples, bone movement is achieved using a bone positioning device that applies a force to one bone through one or more moving components, causing the bone to translate and / or rotate in response to that force. This can be achieved, for example, using a bone positioning guide that includes bone engaging members, tips, a mechanism that presses the bone engaging members and tips toward each other, and an actuator that operates the mechanism. Additionally or alternatively, bone movement can be achieved using a compression stretcher by imparting the movement of one bone relative to another when the compression stretcher is positioned on substantially parallel pins, moving the pins away from their substantially parallel alignment, and resulting in the movement of the underlying bone in one plane (e.g., frontal, sagittal, transverse), two or more planes, or all three planes. As a further addition or alternative, clinicians can facilitate movement by physically grasping the bone, either through direct contact with it or indirectly (e.g., by inserting a K-wire or grasping it with a tenaculum), and moving the bone with their hands.

[0051] During use, the clinician may insert the two-plane instrument 10 between the first metatarsal bone 210 and the second metatarsal bone 212, and between the first metatarsal bone 210 and the medial cuneiform bone 222 (or other adjacent bones if the first metatarsal realignment is not being performed) at any point before moving the first metatarsal bone (e.g., by activating a bone positioning guide or by manipulating the bone otherwise). In one embodiment, the clinician forms the joint being manipulated in order to release soft tissue and / or to excise plantar inflammation from the base of the first metatarsal bone 210. Before or after placing an optional bone positioning guide on an adjacent bone, the clinician inserts the instrument 10 into the joint between the first metatarsal bone and the second metatarsal bone, and into the joint between the first metatarsal bone and the medial cuneiform bone. The clinician may then activate the bone positioning guide 20 (e.g., if used). The distal portion of the first metatarsal bone moves toward the second metatarsal bone in cross-section, closing the immobility mechanism (IMA), thereby rotating the proximal portion of the first metatarsal bone around the pivot body 14 and reducing the IMA between the first and second metatarsal bones. The use of the pivot body 14 can minimize or eliminate base compression between the adjacent bones being manipulated.

[0052] The clinician may additionally engage the osteoplasty guide 30 with the spacer body 12 and use the osteoplasty guide to form the ends of the first metatarsal bone 210 and the medial cuneiform bone 222. The clinician may form one or both ends of the bone before or after moving the first metatarsal bone to one or more planes (e.g., using the osteoplasty guide 30). In either case, the clinician may optionally temporarily fix the moved position to the first metatarsal bone 210 and adjacent bones (e.g., the second metatarsal bone 212, medial cuneiform bone 222) (e.g., by inserting a k-wire or other fixation element). The clinician may remove the bone positioning guide 20 and the two-plane device 10 from the foot, for example, before or after optional temporary fixation. In either case, the clinician may permanently fix the formed ends to fuse them together.

[0053] In one exemplary technique, after conventional surgical preparation and access, an osteoplasty instrument may be inserted into the joint (e.g., the first tarsal metatarsal joint) to release the soft tissue and / or excise the plantar inflammation from the base of the first metatarsal bone 210. Since excising the plantar inflammation may involve cutting the plantar inflammation from the first metatarsal bone 210, the surface of the first metatarsal bone is generally planar. This step helps to move the joint to facilitate correction of the deformity. In some embodiments, the dorsolateral inflammation of the first metatarsal bone may also be excised to create space for deformity correction (e.g., with respect to rotation of the first metatarsal bone). In certain embodiments, the portion of the metatarsal base facing the medial cuneiform bone may be removed during this moving step.

[0054] If an incision can be made and a bone positioning device is to be used, one end (e.g., the tip) of the bone positioning guide 20 is inserted laterally to a metatarsal bone other than the first metatarsal bone 210, such as the second metatarsal bone 212. The tip can be positioned proximal to the interface between the base of the second metatarsal bone 212 and the third metatarsal bone 294.

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

[0056] When the two-plane device 10 includes a bridge member 16, the bridge member is positioned in contact with the proximal transverse angle of the first metatarsal bone 210 and can help position the spacer body 12 and the fulcrum body 14 relative to each other. For example, the bridge member 16 may position the spacer body 12 substantially in the center or lateral half of the articular space between the first metatarsal bone 210 and the medial cuneiform bone 222. The bridge member 16 may further position the fulcrum body 14 within the notch between the first metatarsal bone 210 and the second metatarsal bone 212 at the base of the metatarsals (e.g., each adjacent cuneiform bone). The fulcrum body 14 can provide a point around which the first metatarsal bone 210 can rotate and / or pivot, while helping to minimize or avoid base compression between the first and second metatarsals.

[0057] In applications utilizing the bone positioning guide 20, one or more movable features of the bone positioning guide may be moved to reduce the angle (the transverse angle between the first and second metatarsals) and to rotate the first metatarsal about its axis (frontal plane axial rotation). The first metatarsal 210 can be properly positioned relative to the medial cuneiform 222 by moving the bone engagement 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, rotating the first metatarsal to an anatomically correct position about its longitudinal axis to correct transverse and frontal plane deformities. The position of the first metatarsal 210 relative to the medial cuneiform 222 can be adjusted using other instrumented and / or non-instrumented approaches. Thus, other applications utilizing the two-plane instrument 10 may be carried out without the use of the bone positioning guide 20 and / or without using a bone positioning guide having a different design from the specific examples shown herein.

[0058] Regardless of whether the bone positioning guide 20 is used, exemplary techniques may include positioning the osteoplasty guide 30 on the spacer body 12, as shown in Figure 6 (if the osteoplasty guide is not integrated with the spacer body). A portion of the spacer body 12 projecting dorsally from the articular space between the first metatarsal bone 210 and the medial cuneiform bone 222 can be received within the opening 38 of the osteoplasty guide 30. One or more fixing pins may be inserted into the opening of the osteoplasty guide 30 to fix the guide to the first metatarsal bone 210 and the medial cuneiform bone 222. When the osteoplasty guide 30 is pre-assembled with the two-plane instrument 10 (e.g., detachably coupled to it or fixedly and permanently coupled to it), insertion of the two-plane instrument 10 into the articular space may simultaneously position one or more guide surfaces of the osteoplasty guide 30 on one or more bone surfaces formed using the guide surface (e.g., cut).

[0059] In some applications, the end of the first metatarsal 210 facing the medial cuneiform bone 222 can be formed with a tissue removal instrument guided by the guide surface of the bone formation guide 30 (for example, inserted through a slot defined by the first guide surface and the first surface to face). In some embodiments, the end formation of the first metatarsal 210 is performed after the bone has been at least partially aligned, for example, by activating the bone positioning guide 20 or moving the first metatarsal in a different manner, but after the end of the first metatarsal 210 has been formed. In other embodiments, the end formation of the first metatarsal 210 is performed before the bone has been aligned.

[0060] In addition to forming the end of the first metatarsal bone 210, the end of the medial cuneiform bone 222 facing the first metatarsal bone 210 can be formed with a tissue removal instrument guided by the guide surface of the bone formation guide 30 (for example, inserted through a slot defined by a second guide surface and a second opposing surface). In some embodiments, the end formation of the medial cuneiform bone 222 is performed after bone alignment. In yet another embodiment, the end formation of the medial cuneiform bone 222 is performed before bone alignment. In embodiments involving cutting of bone or cartilage, the cutting of the cuneiform bone and the cutting of the metatarsal bone may be parallel and coincident, or the cuttings may be angled relative to each other. In some examples, a portion of the medial cuneiform bone can be cut by inserting a saw blade through a first slot, and a portion of the first metatarsal bone can be cut by inserting a saw blade through a second slot.

[0061] When the bone formation guide 30 is detachable from the two-plane instrument 10, any angled / converging pins may be removed, and the bone formation guide 30 may be lifted from substantially parallel first and second pins similarly inserted into the bone (or all fixing pins may be removed). The two-plane instrument 10 (or at least the spacer body 12 of the instrument) may be removed from the foot. In some examples, the compression stretcher is positioned downward on parallel pins that remain in the bone or are otherwise attached to the bone.

[0062] In applications where the bone positioning guide 20 is used, the bone positioning guide may be removed before or after the compression stretcher is installed, if the bone formation guide 30 is removed and used. In any case, in some examples, temporary fixation devices such as olive pins, k-wires, or other fixation structures may be used, for example, after the bone formation guide 30 is removed and optionally, while the compression stretcher is installed and / or during permanent fixation, to maintain the position of the underlying bone (e.g., the first metatarsal bone 210 relative to the medial cuneiform bone 222).

[0063] When the compression stretcher is pinned to the underlying bone (e.g., the first metatarsal bone 210 and the medial cuneiform bone 222), the compression stretcher can be operated to stretch the underlying bone. With the underlying bone stretched, the clinician may clean or otherwise form the space between the bones and / or the end faces of one or both bones. The clinician may 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 could obstruct the injector.

[0064] Regardless of whether the clinician uses the compression stretcher 100 to stretch the underlying bone for irrigation, the clinician may engage the compression stretcher to compress the first metatarsal bone toward the medial cuneiform bone.

[0065] With the end faces pressed together (optionally, via the operation of a compression stretcher), a clinician may temporarily and / or permanently fix the bone or bone portion together. For example, one or more bone fixation devices, such as two bone plates positioned in different planes, can be applied across the joint to two bones to stabilize the joint for fusion. For example, a first bone plate may be positioned dorsomedially on the first metatarsal and medial cuneiform bones, and a second bone plate may be positioned medial plantarly on the first metatarsal and medial cuneiform bones. In some embodiments, the bone plate used for fixation may be a helical bone plate positioned medial to the cuneiform bone and plantarly on the first metatarsal bone, crossing the joint space. The plate can be applied by inserting a bone screw. Examples of bone plates that can be used as the first bone plate 310 and / or the second bone plate 320 are described in U.S. Patent Publication No. 2016 / 0192970, filed on January 7, 2016, titled “Bone Plating System and Method,” which is incorporated herein by reference. Other types of bone fixation device configurations may be used, and this disclosure is not limited thereto. For example, intramedullary pins or nails may be used in addition to, or instead of, bone plates.

[0066] The spacer body 12 and the pivot body 14 of the two-plane device 10 may be permanently joined together (for example, so that the spacer bodies cannot be separated from each other without permanently destroying or modifying the device). Alternatively, the spacer body 12 may be detachably connected to the pivot body 14. Such a configuration may allow the spacer body 12 to be removed from the articulation space while the pivot body 14 remains in the articulation space (by performing other separation measures), or vice versa.

[0067] In one embodiment, for example, a clinician may insert a two-plane instrument 10 into the joint space and then realign one bone with respect to the other. Once the bones are realigned relative to each other, the pivot body 14 provides a surface along which adjacent bones can slide and / or prevent compression or base shift between adjacent bones during realignment. After the bones have been realigned relative to each other, the clinician may remove the spacer body 12 from the pivot body 14 and leave the spacer body 12 in the joint space. The bone formation guide 30 can then be placed on the spacer body 12 to facilitate the formation of one or both bones.

[0068] As another example, a clinician may insert a two-plane instrument 10 into the joint space and then insert an osteoplasty guide 30 onto the spacer body 12 of the two-plane instrument 10 (if the osteoplasty guide and instrument are placed separately). The clinician may then use the osteoplasty guide 30 to form the end faces of one or both bones before subsequent realignment. Once one or both end faces of the bones are suitably formed, the clinician may remove the osteoplasty guide 30 and detach the spacer body 12 from the fulcrum body 14. The spacer body 12 is then removed from the joint space, leaving the fulcrum body 14 between adjacent bones for subsequent bone realignment.

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

[0070] In other configurations, the bridge member 16 may be attachable to and detachable from the pivot body 14, or alternatively, attachable to and detachable from the spacer body 12. In yet another configuration, the two-plane fixture 10 may not include a bridge member, but instead consist of a spacer body 12 directly connected to the pivot body 14. In these configurations, the spacer body 12 and the pivot body 14 may have corresponding connections that enable the two bodies to be attachable to and detachable from each other. In general, any feature described as being detachably coupled to each other (e.g., attachable and detachable) may have complementary connection features (e.g., corresponding male and female connection features, corresponding magnetic features) that enable the features to be selectively joined together and separated from each other.

[0071] Regardless of whether the spacer body 12 and the pivot body 14 are detachable from each other, the two-plane instrument 10 can be positioned by joining the two different bodies together. The relative angle between the spacer body 12 and the pivot body 14 may vary depending on the desired application (e.g., the anatomical site where the two-plane instrument 10 is intended to be inserted and / or the anatomical structure of the particular patient in which the two-plane instrument 10 is used). In some examples, the two-plane instrument 10 defines an internal angle between the spacer body 12 and the pivot body 14 (with or without the bridge member 16) in the range of 60 to 120 degrees, e.g., 80 to 100 degrees, or about 90 degrees. The angle between the spacer body 12 and the pivot body 14 may be fixed (the angle is not intended to be adjustable or manipulated by the clinician during use) or variable (the angle may be adjusted by the clinician within the surgical site before insertion and / or while inserted into the patient undergoing the procedure in which the instrument is used).

[0072] In some examples, the angle between the spacer body 12 and the pivot body 14 is defined, for example, by a steep slope, where the spacer body intersects the pivot body at an angle defined between them. In other examples, the two-plane instrument 10 defines a radius of curvature transitioning between the spacer body 12 and the pivot 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 two-plane instrument 10 is shown to have a radius of curvature between the spacer body 12 and the pivot body 14. Configuring the two-plane instrument 10 to have a curved transition (at least on the back side of the instrument) between the spacer body 12 and the pivot body 14 may be useful to provide a smooth surface to help insert the instrument into the patient, for example, by minimizing sharp edges that could catch on the patient's tissue during insertion.

[0073] When the two-plane instrument 10 is configured with a fixed angle between the spacer body 12 and the pivot body 14, the instrument may be made of a material and have a material thickness that is effective in substantially preventing the clinician from changing the angle between the two bodies during use of the instrument. Similarly, the usage associated with the two-plane instrument 10 may indicate that the instrument is intended to be used without manipulating the angle between the spacer body 12 and the pivot body 14.

[0074] In other configurations, the angle between the spacer body 12 and the pivot body 14 may be adjustable by the clinician. For example, the usage associated with the two-plane instrument 10 may indicate that the clinician can adjust the relative positions of the spacer body 12 and the pivot body 14 before and / or after inserting the instrument into the patient. In one example, the two-plane instrument 10 may be made of a material and material thickness that is effective in allowing the clinician to change the angle between the spacer body 12 and the pivot body 14 during use. For example, the two-plane instrument 10 (e.g., the bridge member 16 of the instrument) may be made of a malleable metal and / or polymer material that can be manipulated by the clinician under hand pressure (with or without the assistance of an instrument such as a bending tool) to change the angle between the spacer body 12 and the pivot body 14.

[0075] Additionally or alternatively, the two-plane fixture 10 may include one or more flexible joints (e.g., rotary joints) that allow the angular position of the spacer body 12 to be adjusted relative to the pivot body 14. As an example, the spacer body 12 may be operably connected to the pivot body 14 via one or more cables, allowing the angular orientation of the spacer body 12 and the pivot body 14 to be changed by bending one or more cables. As another example, the spacer body 12 may be operably connected to the pivot body 14 via a hinge connection, allowing the spacer body and the pivot body to rotate relative to each other about a hinge.

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

[0077] During use, the clinician may adjust the angle between the spacer body 12 and the pivot 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 pivot body 14 to be adjusted based on the needs of the condition being treated and / or the specific anatomical structure of the patient receiving treatment. As described above, the clinician may rotate the spacer body 12 and the pivot body 14 relative to each other around the hinge 50 before and / or after forming one or both end faces of the bone that define the joint space into which the spacer body 12 is inserted.

[0078] In some configurations, the spacer body 12 and the pivot body 14 can rotate relative to each other over an unlimited range from rotation (for example, from a first position where the inner surface of the spacer body 12 contacts the inner surface of the pivot body 14 to a second position where the outer surface of the spacer body contacts the outer surface of the pivot body). In other configurations, the spacer body 12 and the pivot body 14 can rotate relative to each other within a limited range of rotation. For example, the two-plane fixture 10 may include one or more rotation stoppers that limit the degree of rotation between the spacer body 12 and the pivot body 14.

[0079] Figures 9A to 9D show exemplary relative rotational positions between the spacer body 12 and the pivot body 14 of the two-plane fixture 10. Figure 9A shows the spacer body 12 extending perpendicularly (at an angle of +90 degrees) to the pivot body 14. Figure 9B shows the spacer body 12 positioned at an acute angle to the pivot body 14. Figure 9C shows the spacer body 12 positioned at an obtuse angle to the pivot body 14. Furthermore, Figure 9D shows the spacer body 12 extending perpendicularly (at an angle of -90 degrees) to the opposite side of the pivot body 14.

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

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

[0082] To engage a surgical instrument (described below with reference to the osteoplasty guide 30 for the purposes of discussion) with a spacer body 12, the surgical instrument may have a receptive 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 receptive opening and the spacer body may be sized and shaped relative to each other to allow the spacer body to be inserted into and / or through the receptive opening of the surgical instrument. In some configurations, the receptive opening of the surgical instrument is sized to match the size of the spacer body 12 that is inserted therein (for example, so 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, even once the spacer body is inserted into the receptive opening of the surgical instrument, the surgical instrument may be sized to allow relative movement between the spacer body and the surgical instrument.

[0083] Figures 10A to 10C show an exemplary system including a two-plane instrument 10 and an osteoplasty guide 30, configured such that the osteoplasty guide moves relative to the spacer body of the two-plane instrument. Figures 10A and 10B are perspective and top views, respectively, showing the spacer body 12 of the two-plane instrument 10 inserted into the receiving opening 38 of the osteoplasty guide 30 in a first position. Figure 10C is a top view showing the spacer body 12 of the two-plane instrument 10 inserted into the receiving opening 38 of the osteoplasty guide 30 in a second position, which is moved in cross-section relative to the first position.

[0084] As shown in the examples in Figures 10A to 10C, the opening 38 of the osteoplasty guide 30 is sized to be larger than the portion of the spacer body 12 received within the opening by one or more dimensions (e.g., only one). In particular, in the examples shown, the opening 38 of the osteoplasty guide 30 is sized to facilitate linear movement of the osteoplasty guide 30 relative to the spacer body 12 in a cross-sectional view when, for example, it is placed on a TMT joint. The opening 38 of the osteoplasty guide 30 has a region 52 that is longer than the length of the spacer body 12 inserted within the opening. As a result, the osteoplasty guide 30 can slide relative to the spacer body 12, while the spacer body protrudes upward through the opening. This may be useful to allow a clinician to reposition one or more guide surfaces 34, 36 of the osteoplasty guide relative to one or more epiphysis being formed, even after the osteoplasty guide has been placed on a spacer body inserted into the joint space.

[0085] Figures 10A and 10B show the osteogenic guide 30 translated to its outermost position (when positioned on the foot) such that the region 52 of the opening 38, which is larger than the spacer body 12, is located outside the spacer body. Figure 10C shows the osteogenic guide 30 translated to its innermost position (when positioned on the foot) such that the region 52 of the opening 38, which is larger than the spacer body 12, is located inside the spacer body. Clinicians may also move the osteogenic guide 30 to one or more intermediate positions within the region 52 of the opening 38, which is larger than the spacer body 12, which is divided between the inner and outer 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 osteoplasty guide can translate a distance of at least 0.5 mm relative to the spacer body 12, for example, at least 1 mm, at least 2 mm, or at least 5 mm. For example, the opening 38 may be sized to be 0.5 mm to 25 mm longer than the length of the spacer body, for example, 1 mm to 10 mm, relative to the portion of the spacer body 12 that will receive it. This may allow a relative movement of 0.5 mm to 25 mm, for example, 1 mm to 10 mm, between the osteoplasty guide and the spacer body. Once the osteoplasty guide 30 is placed on the TMT joint, the osteoplasty guide can be moved relative to the spacer body 12 in a cross-sectional direction (from medial to lateral), utilizing the extra length of the opening 38 relative to the size of the spacer body.

[0087] In some examples, the opening 38 of the osteogenic guide 30 is 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 frontal and / or sagittal planes, in addition to 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 each other in one or more planes. The spacer body 12 and the osteogenic guide 30 may be configured to prevent movement relative to each other in one or more planes by sizing and / or shaping two features relative to each other to prevent or limit movement in one or more planes.

[0088] Referring further to Figures 8A and 8B, the two-plane instrument 10 is shown to include a shelf 54 projecting outward from the rest of the spacer body 12. The shelf 54 may be a region of increased thickness compared to the rest of the spacer body 12. The shelf 54 may extend outward from the rest of the spacer body 12 from one side of the spacer body (e.g., the front) or from multiple sides of the spacer body (e.g., the front and rear), as shown in the examples in Figures 8A and 8B. The shelf 54 may be located above a portion of the spacer body that is insertable into the articular space between adjacent bones. In other words, the shelf 54 may be located on a portion of the spacer body 12 that is insertable into the opening 38 of the osteoplasty guide 30. By configuring the spacer body 12 with the shelf 54, the increased thickness of the spacer body 12 in the region of the shelf 54 may prevent or eliminate relative movement between the spacer body and the osteoplasty guide in the frontal and / or sagittal planes (when placed on the foot). As a result, the bone formation guide 30 may translate relative to the spacer body 12 in the transverse direction, but may be oriented substantially fixed relative to the spacer body in the frontal and / or sagittal planes.

[0089] In the examples shown in Figures 8A and 8B, the two-plane instrument 10 is also illustrated to have projections 56 extending outward from one or both sides of the spacer body 12. The projections 56 may form a bullseye (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, so that clinicians can interpret where the spacer body is located within the joint space and / or relative to the osteoplasty guide 30.

[0090] While the two-plane device 10 has generally been described as useful for insertion into the space between opposing ends of bones transitioning into the intermetatarsal space, the device may be used in any desired application, and this disclosure is not limited in this respect. For example, the two-plane device 10 may be positioned between different bone portions and / or inserted into articular spaces other than those explicitly discussed above. Furthermore, while the two-plane device 10 has generally been described as having a spacer body 12 configured to be positioned within a first articular space and a pivot body 14 configured to be positioned within a second articular space intersecting and angled thereto with respect to the first articular space, the two-plane device may be used with only one of the spacer body 12 and / or the pivot body 14 positioned within the articular space (and / or between different bone portions).

[0091] As one exemplary application, the two-plane device 10 may be used in total ankle replacement surgery. 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 two-plane instrument 10 may be used in total knee replacement surgery. One body (e.g., spacer body 12 or pivot 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 axis of the femur or tibia with the cutting guide.

[0093] As a further exemplary application, the two-plane instrument 10 may be used in total elbow joint replacement surgery. For either ulnar or radial resection, one body (e.g., spacer body 12 or pivot body 14) may be inserted between the ulna and the humerus. The other body may be positioned around either the medial or lateral (ulna or humerus) side of the bone to set the angle of the cut relative to either bone.

[0094] Various embodiments have been described. These and other embodiments are within the scope of the following claims. [Configuration 1] A two-plane instrument for bone cutting and joint realignment procedures, A spacer body configured to be inserted into the articular space between the metatarsal bones of the foot and the opposing cuneiform bones, A device comprising: a pivot body coupled to a spacer body, wherein the pivot body is configured to be inserted into the intermetatarsal space between a metatarsal bone and an adjacent metatarsal bone. [Configuration 2] The spacer body is configured to have a length such that it is inserted into the joint space, a thickness such that it extends between the metatarsal bone and the opposing cuneiform bone, and a width such that it extends from the inside to the outside over at least a portion of the joint space. The device according to configuration 1, wherein the fulcrum body has a defined 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 along the foot in a proximal to distal direction. [Configuration 3] The device according to configuration 1 or 2, further comprising a bridge extending between the spacer body and the pivot body, wherein the pivot body is connected to the spacer body via the bridge. [Structure 4] The device according to configuration 3, wherein the spacer body is configured to extend within a first plane of the leg, the pivot body is configured to extend within a second plane of the leg, and the bridge member transitions from the first plane to the second plane. [Composition 5] The device according to configuration 3 or 4, wherein the bridge member is configured to extend from the proximal side of the metatarsal bone to the lateral side of the metatarsal bone. [Composition 6] The device according to any one of configurations 1 to 5, wherein the angle defined between the spacer body and the pivot body is within the range of 60 degrees to 120 degrees. [Composition 7] The device according to any one of configurations 1 to 6, wherein the spacer body is fixedly connected to the pivot body. [Structure 8] The device according to any one of configurations 1 to 7, wherein the spacer body is hinged to the spacer body. [Composition 9] The device according to configuration 8, wherein the spacer body is configured to rotate at least 180 degrees relative to the pivot body to facilitate use on both the right and left feet. [Configuration 10] The device according to any one of configurations 1 to 9, wherein the spacer body is detachably connected to the pivot body. [Composition 11] The device according to any one of configurations 1 to 10, wherein the spacer body defines a first portion configured to extend within the articular space between the metatarsal bone and the opposing cuneiform bone, and a second portion configured to extend above the articular space, and the second portion is configured to engage with a receiving opening of the bone formation guide. [Composition 12] The device according to configuration 11, wherein the bone formation guide defines at least one cutting slot configured to be positioned on the metatarsal bone, and the at least one cutting slot configured to be positioned on the opposing cuneiform bone. [Composition 13] The device according to configuration 11 or 12, wherein the second portion of the spacer body is smaller in size than the receiving opening of the bone formation guide so that the bone formation guide can move in at least one plane relative to the spacer body when the spacer body is inserted into the receiving opening. [Composition 14] The device according to configuration 13, wherein the second portion of the spacer body further comprises a shelf extending outward from at least one front and rear surface of the spacer body, the shelf restricting movement between the bone formation guide and the spacer body. [Composition 15] The device according to any one of configurations 1 to 14, further comprising a bone formation guide permanently attached to the spacer body. [Composition 16] The device according to any one of configurations 1 to 15, further comprising a handle connected to the pivot body, wherein the handle protrudes away from the pivot body. [Composition 17] The aforementioned metatarsal bone is the first metatarsal bone. The opposing cuneiform bones are medial cuneiform bones. The device according to any one of configurations 1 to 16, wherein the adjacent metatarsal bone is the second metatarsal bone. [Composition 18] It is a method, The spacer body is inserted into the articular space between the metatarsal bone and the opposing cuneiform bone, Insert the pivot body connected to the spacer body between the aforementioned metatarsal bone and the adjacent metatarsal bone, Using the spacer and the bone formation guide aligned thereto, the bone formation instrument is guided to form the end of the metatarsal bone, Using the bone formation guide, the bone formation instrument is guided to form the ends of the opposing cuneiform bones, A method comprising moving the metatarsal bone relative to the adjacent metatarsal bone, at least in cross-section, thereby rotating the metatarsal bone around the pivot body and reducing the intermetatarsal angle between the metatarsal bone and the adjacent metatarsal bone. [Composition 19] The method according to configuration 18, wherein the spacer body is connected to the support body using a bridge member. [Configuration 20] The method according to configuration 19, wherein inserting the spacer body and inserting the pivot body involves inserting a single device including the spacer body coupled to the pivot body via the bridge member. [Composition 21] The method according to configuration 20, wherein inserting the single device includes positioning the bridge member with respect to the proximal transverse angle of the metatarsal bone. [Composition 22] The method according to any one of configurations 18 to 21, wherein the spacer body is fixedly connected to the pivot body. [Composition 23] The method according to any one of configurations 18 to 22, wherein the angle defined between the spacer body and the pivot body is within the range of 60 degrees to 120 degrees. [Composition 24] The method according to any one of configurations 18 to 24, further comprising adjusting the angle defined between the spacer body and the pivot body. [Composition 25] The method according to configuration 24, wherein the spacer body is attached to the pivot body by a hinge, and adjusting the angle defined between the spacer body and the pivot body includes rotating the spacer body relative to the pivot body about the hinge connection. [Composition 26] The method according to configuration 24, wherein adjusting the angle defined between the spacer body and the pivot body includes bending a malleable portion of the material connecting the spacer body to the pivot body. [Composition 27] The method according to any one of configurations 18 to 26, wherein inserting the spacer body into the joint space includes inserting the first portion of the spacer body into the joint space with the second portion of the spacer body extending over the joint space, and further includes aligning the bone formation guide with the second portion of the spacer body. [Composition 28] The method according to configuration 27, wherein the second portion of the spacer body is smaller in size than the receiving opening of the osteoforming guide into which the second portion of the spacer body is inserted, and further comprises moving the osteoforming guide in at least one plane relative to the spacer body while the spacer body is inserted into the receiving opening. [Composition 29] The method according to configuration 28, wherein the second portion of the spacer body further comprises a shelf extending outward from at least one front and rear surface of the spacer body, the shelf restricting movement between the bone formation guide and the spacer body. [Composition 30] The method according to any one of configurations 18 to 29, wherein the bone formation guide is permanently connected to the spacer body, and inserting the spacer body into the joint space includes positioning the bone formation guide on the metatarsal bone and the opposing cuneiform bone. [Composition 31] The method according to any one of configurations 18 to 30, further comprising a handle protruding away from the pivot body at a non-zero angle, wherein inserting the pivot body involves laterally opening the tissue away from the incision providing access to the metatarsal bone and the adjacent metatarsal bone, and holding the tissue away from the incision within a tissue opening space formed between the handle and the pivot body. [Composition 32] The aforementioned metatarsal bone is the first metatarsal bone. The opposing cuneiform bones are medial cuneiform bones. The method according to any one of configurations 18 to 31, wherein the adjacent metatarsal bone is the second metatarsal bone. [Configuration 33] The method according to any one of configurations 18 to 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. [Composition 34] The method according to configuration 33, wherein removing at least the spacer body further includes removing the pivot body coupled to the spacer body. [Composition 35] The method according to any one of configurations 18 to 34, wherein fixing the formed end of the metatarsal bone to the formed end of the opposing cuneiform bone includes inserting a fixing member across the tarsometatarsal joint. [Composition 36] The method according to any one of configurations 18 to 35, wherein forming the end of the metatarsal bone and forming the end of the opposing cuneiform bone includes 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. An instrument for bone cutting and joint correction procedures, A first body configured to be inserted into the articular space between the metatarsal bones of the foot and the opposing cuneiform bones, A second body permanently coupled to the first body, the second body being configured to be inserted into the intermetatarsal space between the metatarsal bone and an adjacent metatarsal bone while the first body is inserted into the joint space, the device comprising a second body defining a transition from the first body to the second body, which is configured to extend around the proximal lateral portion of the metatarsal bone, A bone formation guide permanently attached to the first body, configured to guide bone formation instruments for forming the ends of the metatarsal bones and / or the ends of the opposing cuneiform bones, An instrument equipped with the necessary features.

2. The apparatus according to claim 1, further comprising a bridge extending between the first body and the second body, wherein the second body is permanently coupled to the first body via the bridge, and the transition portion is defined by the bridge.

3. The apparatus according to claim 1 or 2, wherein the transition portion defines the radius of curvature.

4. The apparatus according to any one of claims 1 to 3, wherein the transition portion from the first body to the second body defines an angle, and the angle is in the range of 60 degrees to 120 degrees.

5. The apparatus according to claim 4, wherein the angle is fixed.

6. The apparatus according to claim 4, wherein the angle is adjustable.

7. The instrument according to any one of claims 1 to 6, wherein the bone formation instrument includes a saw blade, and the bone formation guide includes a guide surface configured to guide the saw blade.

8. The instrument according to any one of claims 1 to 6, wherein the bone-forming instrument includes a saw blade, and the bone-forming guide includes at least one cutting slot configured to be positioned on the metatarsal bone and / or the opposing cuneiform bone, the at least one cutting slot configured to guide the saw blade for forming the end of the metatarsal bone and / or the end of the opposing cuneiform bone.

9. The device according to claim 8, wherein the bone formation guide defines at least one cutting slot configured to be positioned on the metatarsal bone and at least one cutting slot configured to be positioned on the opposing wedge bone.

10. The device according to any one of claims 1 to 9, wherein the bone formation guide is movable relative to the first body.

11. The device according to claim 10, wherein the bone formation guide is configured to move linearly from the inside to the outside relative to the first body.

12. The apparatus according to claim 10, wherein the first body includes a shelf extending outward from at least one of the front and rear surfaces of the first body, the shelf restricting movement between the bone formation guide and the first body.

13. The device according to any one of claims 1 to 9, wherein the bone formation guide is fixedly positioned relative to the first main body.

14. The apparatus according to any one of claims 1 to 13, further comprising a handle protruding outward from the second body.

15. The metatarsal bone is the first metatarsal bone, The opposing cuneiform bones are medial cuneiform bones. The adjacent metatarsal bone is the second metatarsal bone. The apparatus according to any one of claims 1 to 14.

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