Bone positioning guide

Abstract

To provide a bone positioning guide.SOLUTION: A bone positioning guide may include a main body member, a shaft, and a bone engagement member. The shaft can be movably connected to the main body member and have the bone engagement member rotatably coupled to its distal end. The bone engagement member can have a surface configured to engage a bone. The main body member can also include a tip opposite the bone engagement member for engaging a second bone. In use, the bone engagement member may be positioned in contact with a medial side of a first metatarsal while the tip is positioned in contact with a lateral face of a different metatarsal, such as a second metatarsal. The shaft can then be moved to advance the bone engagement member toward the tip, causing realignment of the first metatarsal.SELECTED DRAWING: Figure 1

Description

Cross - reference to related applications

[0001] This application is a continuation of U.S. Patent Application No. 14 / 981,335, filed on December 28, 2015, and claims the benefit of U.S. Provisional Patent Application No. 62 / 205,338, filed on August 14, 2015, and U.S. Provisional Patent Application No. 62 / 192,319, filed on July 14, 2015. The entire contents of all these applications are incorporated herein by reference.

Technical Field

[0002] The present disclosure generally relates to devices and methods for positioning bones.

Background Art

[0003] Bones, such as the bones of the foot, may be anatomically misaligned. In certain situations, surgical intervention is necessary to correctly align the bones to reduce patient discomfort and improve the patient's quality of life. Conventionally, bone realignment procedures require surgical intervention, in which the surgeon manually realigns the bone and then attempts to fixate the bone in its realigned position. Due to the complexity of attempting to hold the bone in its realigned position while manually realigning the bone and then fixing the bone in its adjusted position, inconsistent treatment results may occur.

Summary of the Invention

[0004] In general, this disclosure covers bone positioning guides and methods for using bone positioning guides. In some examples, the bone positioning guide includes a body having a first end and a second end. The body can wrap around or bend around itself such that the first end faces the second end, with a bone repositioning space defined between the first and second end. For example, the body may have a first bend of approximately 90 degrees and a second bend of approximately 90 degrees, and may have a straight body portion separating the two bends. The first end of the body may have an aperture for a threaded shaft, through which a threaded shaft extends. The shaft may carry a bone-engaging member on the distal end of the shaft configured to engage with bone. The second end of the body may have a tip also configured to engage with bone.

[0005] During use, the shaft can be retracted from the main body in the bone positioning guide (for example, so that the bone engagement member is positioned adjacent to or in contact with the first end of the main body), or the clinician can retract the shaft to increase the space between the bone engagement member and the tip. In either case, the clinician can position the tip in contact with a first bone and position the bone engagement member in contact with a second bone. For example, the clinician can position the tip in contact with the lateral side of the second metatarsal bone and translate the shaft relative to the main body until the bone engagement member contacts the medial side of the first metatarsal bone. The clinician can continue to translate the shaft relative to the main body, and the bone engagement member will advance toward the tip.

[0006] As the bone engagement member advances toward the tip, the position of the first metatarsal bone can be repositioned and corrected relative to the second metatarsal bone. For example, the position of the first metatarsal bone can be repositioned in three planes, including the frontal, transverse, and sagittal planes. After advancing the bone engagement member toward the tip to a position where a suitable repositioning is achieved (as determined, for example, by the clinician performing the procedure), the clinician can fix the repositioned position of the first metatarsal bone while the bone positioning guide holds the first metatarsal bone in the repositioned position. For example, while the bone positioning guide holds the first metatarsal bone in the repositioned position, the clinician can securely fix the first metatarsal bone to the medial cuneiform bone in the repositioned position using pins, screws, plates, wires, and / or other desired fixation devices.

[0007] In one example, the bone positioning guide is described to include a main body member, a shaft, and a bone engagement member. The shaft is movably connected to the main body member proximal to the first end of the main body. The bone engagement member is rotatably connected to the shaft and has a surface configured to engage with bone. Furthermore, the bone positioning guide includes a tip at the second end of the main body opposite the first end.

[0008] Another example describes a method for positioning bones. This method includes engaging the surface of a bone engagement member of a bone positioning guide with a first bone, and positioning the tip of the bone positioning guide alongside a second bone different from the first bone. The method further includes moving the bone engagement member relative to the tip to change the position of the first bone relative to the second bone.

[0009] Details of one or more examples are shown in the attached drawings and description below. Other features, purposes, and advantages will become apparent from the description and drawings, and from the claims. [Brief explanation of the drawing]

[0010] [Figure 1]This is a side perspective view of a bone positioning guide according to an embodiment of the present invention.

[0011] [Figure 2] This is a side perspective view of the bone engagement member of a bone positioning guide according to an embodiment of the present invention.

[0012] [Figure 3A] This is a side perspective view of the tip of a bone positioning guide according to an embodiment of the present invention.

[0013] [Figure 3B] This is a side view of a bone positioning guide having a linear tip according to an embodiment of the present invention.

[0014] [Figure 3C] This is a side view of a bone positioning guide having a non-linear tip according to an embodiment of the present invention.

[0015] [Figure 4] This is an end view of the actuator for a bone positioning guide according to an embodiment of the present invention.

[0016] [Figure 5] This is a top view of a bone preparation guide according to an embodiment of the present invention.

[0017] [Figure 6A] This is a perspective view of a bone preparation guide, spacer, and tissue removal instrument position confirmation member according to an embodiment of the present invention.

[0018] [Figure 6B] This is a perspective view of another embodiment of the tissue removal instrument confirmation position member engaged with the bone preparation guide.

[0019] [Figure 7] This is a perspective view of a bone preparation guide engaged with a spacer according to an embodiment of the present invention.

[0020] [Figure 8]Perspective view of a bone preparation guide engaged with a tissue removal instrument position confirmation member according to an embodiment of the present invention.

[0021] [Figure 9A] Front view of a bone positioning guide on a deformed foot according to an embodiment of the present invention.

[0022] [Figure 9B] Front view of a bone positioning guide on a foot with alignment corrected according to an embodiment of the present invention.

[0023] [Figure 10A] Top view of a bone positioning guide on a deformed foot according to an embodiment of the present invention.

[0024] [Figure 10B] Top view of a bone positioning guide on a foot with alignment corrected according to an embodiment of the present invention.

[0025] [Figure 11A] Diagram showing a series of bone positioning procedures using a bone positioning guide on a foot at a first position according to an embodiment of the present invention. [Figure 11B] Diagram showing a series of bone positioning procedures using a bone positioning guide on a foot at a second position according to an embodiment of the present invention. [Figure 11C] Diagram showing a series of bone positioning procedures using a bone positioning guide on a foot at a third position according to an embodiment of the present invention.

[0026] [Figure 12A] Front view of a foot having a normal first metatarsal position.

[0027] [Figure 12B] Front view of a foot having an abducted first metatarsal with valgus hallux deformity.

[0028] [Figure 13A] Top view of a foot having a normal first metatarsal position.

[0029] [Figure 13B] This is a top view of a foot with transverse plane bunion deformity of the first metatarsal bone, which is separated from the others.

[0030] [Figure 14A] This is a lateral view of a foot with the first metatarsal bone in its normal position.

[0031] [Figure 14B] This is a lateral view of a foot with sagittal plane bunion deformity of the detached first metatarsal bone.

[0032] [Figure 15A] These are oblique and enlarged views of the foot.

[0033] [Figure 15B] This is a perspective view of the first metatarsal bone.

[0034] [Figure 16] This is a lateral perspective view of a foot showing a bone-adjusting instrument inserted into a joint.

[0035] [Figure 17] This is a perspective view of the foot showing a guide for the positioning of the bones on the foot before alignment of the first metatarsal bone.

[0036] [Figure 18] This is a perspective view of the foot showing a guide for the positioning of the bones on the foot after the alignment of the first metatarsal bone.

[0037] [Figure 19] This is a perspective view of the foot showing the alignment of the first metatarsal bone and a guide for positioning the bones on the foot after insertion of a spacer into the joint cavity.

[0038] [Figure 20]This is a perspective view of the foot showing the positioning guide for the bones on the foot after the alignment and bone adjustment guide for the first metatarsal bone has been positioned.

[0039] [Figure 21A] This is a perspective view of the foot showing the bone positioning guide on the foot after the alignment of the first metatarsal bone and the positioning of the bone adjustment guide with pins.

[0040] [Figure 21B] This is another perspective view of the foot showing the bone positioning guide on the foot after the alignment of the first metatarsal bone and the positioning of the bone adjustment guide with pins.

[0041] [Figure 22] This is a perspective view of a foot showing a bone preparation instrument used to prepare the bones of the foot, guided by the guide surface of a bone preparation guide.

[0042] [Figure 23] This is a perspective view of the foot showing the removal of the bone positioning guide and bone adjustment guide on the foot.

[0043] [Figure 24] A perspective view of the foot showing bone positioning guides and pins on the foot.

[0044] [Figure 25] This is a perspective view of the foot showing the bone positioning guides and compression pins on the foot.

[0045] [Figure 26A] This is a side perspective view of a foot showing a bone plate and compression pins extending across the joint between a first bone and a second bone according to an embodiment of the present invention.

[0046] [Figure 26B] This is a side perspective view of a foot showing a bone plate and compression pins extending across the joint between a first bone and a second bone according to an embodiment of the present invention.

[0047] [Figure 27]This is a side perspective view of a foot showing a bone plate spanning the joint between a first bone and a second bone according to an embodiment of the present invention.

[0048] [Figure 28A] This figure shows an example of anatomically misaligned metatarsals and an example of metatarsals that have been anatomically aligned using the method and / or apparatus according to the present invention. [Figure 28B] This figure shows an example of anatomically misaligned metatarsals and an example of metatarsals that have been anatomically aligned using the method and / or apparatus according to the present invention.

[0049] [Figure 29A] This figure shows an example of anatomically misaligned metatarsals and an example of metatarsals that have been anatomically aligned using the method and / or apparatus according to the present invention. [Figure 29B] This figure shows an example of anatomically misaligned metatarsals and an example of metatarsals that have been anatomically aligned using the method and / or apparatus according to the present invention.

[0050] [Figure 30A] This figure shows a portion of a foot with hallux valgus caused by the first metatarsal bone being misaligned with the second metatarsal bone.

[0051] [Figure 30B] Figure 30A shows an example of base compression that can occur after the foot has been anatomically aligned.

[0052] [Figure 31] This diagram illustrates an exemplary bone positioning procedure in which a lever is positioned at the intersection between the first and second bones.

[0053] [Figure 32] This is a perspective view of one example lever.

[0054] [Figure 33] This diagram shows an exemplary system of levers of different dimensions.

[0055] [Figure 34] This is a perspective view of another bone positioning guide according to an embodiment of the present invention.

[0056] [Figure 35] This figure shows an exemplary configuration of a joint spacer around which a bone adjustment guide can rotate.

[0057] [Figure 36A] This is a perspective view of an exemplary configuration of a bone positioning guide having an opening with a circular cross-sectional shape.

[0058] [Figure 36B] This is a perspective view of an exemplary bone positioning guide shown in Figure 36A, which includes the joint spacer shown in Figure 35 inserted within the guide. [Modes for carrying out the invention]

[0059] The following detailed description is illustrative in nature and is not intended to limit in any way the scope, uses, or configuration of the present invention. Rather, the following description provides a practical guide for carrying out exemplary embodiments of the present invention. Examples of structures, materials, and dimensions are provided for selected elements, and all other elements are known to those skilled in the art of the present invention. Those skilled in the art will understand that many of the examples described have a variety of suitable substitutes.

[0060] Embodiments of the present invention include a bone positioning guide and a method for positioning a bone in a medical procedure. In exemplary applications, embodiments of the bone positioning guide may be useful during surgical procedures such as bone alignment, osteotomy, fixation, and / or other procedures where one or more bones need to be prepared (e.g., removal and / or cutting of cartilage or bone). For example, in the foot or hand, where the bones are relatively small compared to the bones of other parts of the human body structure, such procedures can be performed on the bone (e.g., adjacent bones separated by a joint or different parts of a single bone). In one example, in a bunion correction procedure, an embodiment of the bone positioning guide can be used to correct the alignment between the metatarsal bones (e.g., the first metatarsal bone) and the second metatarsal bone and / or the cuneiform bones (e.g., the medial cuneiform bone or the first cuneiform bone). An example of such a procedure is the Rapidus procedure (also known as first tarsal-metatarsal fixation). In other examples, the procedure can be performed by correcting the alignment of the metatarsal bones (e.g., the first metatarsal bone). One example of such a procedure is metatarsal base osteotomy.

[0061] Figure 1 shows a side perspective view of a bone positioning guide 10 according to an embodiment of the present invention. The bone positioning guide 10 may be useful for positioning (e.g., aligning and / or translating) bones during medical procedures. In some embodiments, the bone positioning guide includes a bone engagement member, a tip, a mechanism for pushing the bone engagement member and the tip toward each other (e.g., moving the bone engagement member toward the tip, moving the tip toward the bone engagement member, or moving both simultaneously), and an actuator for operating the mechanism. When the mechanism is operated, it moves a first bone engaged with the bone engagement member to correct alignment in two or more planes with respect to a second bone in contact with the tip. In some embodiments, the correction in two or more planes includes correction around an axis in the frontal plane.

[0062] In the embodiment shown in Figure 1, the bone positioning guide 10 includes a main body member 20 and a shaft 30, with a bone engagement member 40 connected to the shaft and a tip 50 connected to the main body member. Generally, the main body member 20 can be sized and shaped so that biomolecules or other devices (e.g., pins and guides) are clearly visible while being positioned on the patient. In the embodiment shown in Figure 1, the main body member 20 includes a generally C-shaped form with a first end 60 and a second end 70. In some embodiments, the body is sized and configured to engage with the bones of the human foot. In addition, although the bone positioning guide 10 is illustrated as being formed from two components, the main body member 20 and the shaft 30, the guide may be made from more (e.g., three, four, or more) components that join together to form the guide.

[0063] The shaft 30 can be movably connected to the main body member 20 proximal to the first end 60 of the main body member 20. In some embodiments, the shaft 30 includes threads 80 that engage with the main body member 20, and rotation of the shaft causes the shaft to translate relative to the main body member. In other embodiments, the shaft can slide within the range of the main body member and can be fixed to the main body member at a desired position by a positioning screw. In yet another embodiment, the shaft can be moved relative to the body by a ratchet mechanism. In the illustrated embodiment, the shaft moves along an axis intersecting the tip 50. In other embodiments, such as those described with respect to Figure 34, the shaft 30 and / or the bone engagement member 40 are offset from the tip 50.

[0064] As shown in Figure 2, embodiments of the bone positioning device may have a bone engagement member 40. In some embodiments, the bone engagement member includes a surface 90 configured to contact a bone, such as a metatarsal or cuneiform bone. In the illustrated embodiment, the surface 90 is concave. Such a surface is adapted to facilitate surface contact with a generally cylindrical bone, such as a metatarsal bone. Other embodiments of the surface shape include planar and V-shaped surfaces. When using a concave or V-shaped bone engagement member 40, the side walls of the recess or V-shaped groove may be symmetrical or asymmetrical. In a symmetrical configuration, the bottom of the recess or groove may be located midway between upward-extending side walls configured to receive the bone. Each side wall may extend upward to the same height and / or at the same incline. In an asymmetrical configuration, one side wall may have a different shape from the opposing side wall. For example, one of the side walls may extend upward from the bottom of the recess or groove to a lower height than the opposing side wall. As another example, one side wall may extend upward at a different angle than the opposing side wall. An asymmetrical configuration may be useful for imparting a lateral biasing force rather than a simply linear force toward the tip 50.

[0065] In some embodiments, the bone engagement member 40 includes a pin or clamp. Regardless of whether the bone engagement member 40 includes such a pin or clamp, the bone engagement member can engage with anatomical features of the bone, such as a ridge (e.g., the medial ridge of the first metatarsal bone). In such embodiments, the engagement generally prevents rotational movement of the bone relative to the bone engagement member. In other embodiments, the bone may be able to rotate relative to the bone engagement member.

[0066] In the illustrated embodiment, the bone engagement member 40 is provided at the end of the shaft 30. In the illustrated embodiment of the shaft having a screw thread 80, the bone engagement member 40 can be rotatably connected to the shaft 30. In such an embodiment, when the shaft rotates relative to the main body member, the bone engagement member 40 may or may not rotate relative to the main body member, even if it translates relative to the main body member together with the shaft 30 and rotates relative to the shaft. The bone engagement member can swing around the shaft 30, but after contact with the bone, it does not rotate relative to the bone.

[0067] Figures 3A to 3C illustrate the tip portion 50 of the bone positioning guide 10, which may be located on the second end 70 of the main body member opposite the first end. The tip portion 50 may be useful for contacting bones other than those generally in contact with the bone engagement member. For example, if the bone engagement member is in contact with the first metatarsal bone, the tip portion may be able to contact other metatarsal bones (e.g., the second, third, fourth, or fifth metatarsal bones). In some embodiments, the tip portion is tapered to facilitate percutaneous insertion and contact with bone. The tip portion may also include a textured surface 100, such as serrated, roughened, oblique grid, or notched, to reduce slippage between the tip portion and the bone. In the illustrated embodiment, the tip portion further includes a stopper 110 for limiting the depth of insertion. The shape of the tip portion may be configured to make stable contact with bone. For example, Figure 3B shows a side view of a bone positioning guide having a generally straight tip 50, while Figure 3C shows a side view of a bone positioning guide having a non-straight tip 50 (e.g., an angled or curved tip). In some embodiments, the tip is configured to restrict translational motion between the tip and the bone, but to allow rotational motion between the tip and the bone.

[0068] As shown in Figure 4, the bone positioning guide 10 may also include an actuator (e.g., a knob or handle) 120 for operating the mechanism, in this embodiment relating to the shaft. In the illustrated embodiment, the actuator may be useful for allowing the user to rotate the shaft relative to the main body member 20. Also, as shown in Figure 4, the actuator, shaft, and bone engagement member may include an intubation 130 for arranging a fixing wire (e.g., a K-wire) that contacts or passes through the bone engaged with the bone engagement member. For example, the fixing wire can be inserted into the bone engaged with the bone engagement member 40 to fix the position of the bone engagement member relative to the bone. In another example, the fixing wire can pass through the bone in contact with the bone engagement member and into an adjacent bone to maintain the bone position of the bone in contact with the bone engagement member and the adjacent bone.

[0069] In other embodiments, the mechanism for pushing the bone engagement member and the tip toward each other may include a support hook structure or a tong structure. In such embodiments, the guide may include a first shaft pivotably connected to a second shaft. The first end of each shaft may include an actuator, such as a handle. The second end of the first shaft may include a bone engagement member, as described above. The second end of the second shaft may also include a tip, as described above. During use, the actuator can be operated to move the bone engagement member and the tip toward each other (e.g., by pushing them together) to position the bone. Other embodiments of this type may include other sets of shafts and other pivot connections such that the bone engagement member and the tip translate toward each other when the actuator is operated.

[0070] In other embodiments, the mechanism for pushing the bone engagement member and the tip toward each other may include a rack and pinion structure. In such embodiments, the rack may include the tip as described above. The pinion may also include the bone engagement member and an actuator (e.g., a knob) as described above. During use, the actuator can be actuated to move the bone engagement member and the tip toward each other (for example, by changing their orientation around an axis approximately perpendicular to the direction of travel) to position the bone.

[0071] Embodiments of the bone positioning guide may include any suitable material. In certain embodiments, the bone positioning guide is made from a radiolucent material such as thermoplastics and carbon fiber materials, so as to be relatively transparent to X-rays and other forms of radiation. Such materials are useful because they do not interfere with the visualization of the bone when using an imaging device while the bone positioning guide is positioned over the bone.

[0072] Embodiments of bone positioning guides may be useful in procedures to temporarily position one or more bones during medical procedures. Bone positioning may be useful, for example, to correct anatomical misalignment of bones and to temporarily maintain an anatomically aligned position in bone alignment and / or fixation procedures. In some embodiments, the bone positioning guide can reduce the angle between the first and second metatarsals from more than 10 degrees (e.g., up to about 35 degrees) to about 10 degrees or less (e.g., up to about 1 to 5 degrees), including a negative angle of about -5 degrees. In some embodiments, the bone positioning guide can also rotate the first metatarsal bone around its long axis with respect to the medial cuneiform bone from a rotation angle of more than 4 degrees to a rotation angle of less than 4 degrees (e.g., up to about 0 to 2 degrees).

[0073] In some embodiments, a bone preparation guide may be provided to facilitate bone preparation. The bone preparation guide may be provided together with a bone positioning guide, or either device may be provided or used independently. An example of a bone preparation guide 150 is shown in Figure 5. In some embodiments, the bone preparation guide 150 includes a body 154 that defines a first guide surface 160 defining a first preparation plane and a second guide surface 164 defining a second preparation plane. A tissue removal instrument (e.g., a saw, rotary bar, bone knife, etc., not shown) can be aligned with the surface to remove tissue (e.g., remove cartilage or bone and / or make an incision in the bone). The first and second guide surfaces 160, 164 can be spaced apart from each other by a distance (e.g., about 2 mm to about 10 mm, such as about 4 to about 7 mm). In the illustrated embodiment, the first and second guide surfaces are parallel, so that the incisions in adjacent bones using the guide surfaces are generally parallel.

[0074] In some embodiments, as shown in Figure 5, the first opposing surface 166 is positioned adjacent to the first guide surface 160 and / or the second opposing surface 168 is positioned adjacent to the second guide surface 164. In such embodiments, the distance between the first guide surface and the first opposing surface defines the first guide slot, and the distance between the second guide surface and the second opposing surface defines the second guide slot. Each slot can be sized to receive a tissue removal instrument for preparing the epiphysis. The first and second slots may be parallel or oblique. In the illustrated embodiments, the opposing surfaces each contain gaps, so the surfaces are not a single continuous surface. In other embodiments, the opposing surfaces may be a single continuous surface without any such gaps.

[0075] An opening 170 can be defined by the body 154 between the first and second guide surfaces. The opening can be a region between the guide surfaces that is useful for the practitioner to have a visual path to the bone and / or to receive an instrument while preparing the bone. In the illustrated embodiment, the opening extends across the body and over a distance from the surface 172 opposite the first opposing surface 166 to the surface 174 opposite the second opposing surface 168.

[0076] The illustrated embodiment also includes a first end 176 extending from the body 154 in a first direction and a second end 178 extending from the body in a second direction. The second direction may be different from the first direction (for example, it may be the opposite direction). As shown, each of the first and second ends may include at least one fixing aperture 180 configured to receive a fixing pin (not shown in Figure 5) for fixing the guide to bone. As shown, such an aperture may extend through the end at an angle perpendicular or inclined to the upper surface of the guide.

[0077] The bone preparation guide 150 may also include a first adjustable stabilizing member 182 engaged with the first end 176. In some embodiments, the bone preparation guide may include a second adjustable stabilizing member 184 engaged with the second end 178. Each member may be threaded and engaged with a threaded aperture defined by the end. The height of each end may be adjusted relative to the bone by adjusting the stabilizing member. In some embodiments, as shown, the stabilizing member is fitted with an intubation to receive a fixation pin.

[0078] As shown in Figures 6A and 7, the bone preparation guide may also include a spacer 188 that extends downward from the main body 154 and is configured to enter the joint. In some embodiments, the spacer 188 is selectively engageable with the main body. The spacer may have a first portion 190 configured to extend into the joint cavity and a second portion 192 that is engageable with the main body 154. In the illustrated embodiment, the spacer can be received within the opening 170, so the spacer extends from the main body between the first and second guide surfaces. Such a spacer may be useful for positioning the main body at a desired position relative to the joint and for properly positioning the guide with respect to the bone to be cut in two or more planes (e.g., three planes selected from two or more of the frontal, transverse, and sagittal planes). The distance between the spacer and the first guide surface can define the length of tissue removal from the first bone (e.g., bone or cartilage to be cut), and the distance between the spacer and the second guide surface can define the length of tissue removal from the second bone (e.g., bone or cartilage to be cut).

[0079] As shown in Figures 6A / B and 8, the bone preparation guide may also include a tissue removal position confirmation member 194, which is engaged with the main body 154 and configured to extend into the first and second bones. The tissue removal position confirmation member may have a first portion 196 configured to extend to contact the first and second bones, and a second portion 198 engaged with the main body. In the embodiments shown in Figures 6A and 8, the tissue removal position confirmation member extends from the main body on both the first and second guide surfaces. In other embodiments, such as the embodiment shown in Figure 6B, a separate tissue removal position confirmation member is provided for independent insertion into the corresponding slot of the guide. Thus, embodiments of the tissue removal position confirmation member are useful to allow the practitioner to see where the surface-guided tissue removal instrument will contact the bone to be prepared.

[0080] Embodiments of bone preparation guides may be useful in procedures to guide the preparation of one or more bones in a target biological structure. Bone preparation may be useful in procedures such as bone alignment and / or fixation to facilitate contact between the distal edges of adjacent bones separated by a joint or between different parts of a single bone separated by a fracture.

[0081] Embodiments of the present invention also include, for example, a method for temporarily fixing the orientation of one or more bones before or simultaneously with permanently fixing the orientation of one or more bones. Generally, a bone positioning method includes the steps of moving a bone from a position anatomically misaligned with respect to other bones to an anatomically aligned position, and preparing the ends of the moved bone and the opposing ends of the other bones. In some embodiments, the ends of the moved bone and at least one of the other bones are prepared after the bone has been moved to the aligned position. In certain embodiments, a bone is anatomically aligned with respect to other bones in two or more planes by applying force to one bone in a single location such that the bone both translates and rotates in response to the force. In certain embodiments, as described herein, the moving step can be completed by a bone positioning device and / or the preparing step can be completed by a bone preparation guide.

[0082] Figures 9A and 9B show frontal views of a bone positioning guide 10 on a foot 200 having a first metatarsal bone 210, a medial cuneiform bone 220, a second metatarsal bone 292, and a third metatarsal bone 294. Figure 9A illustrates a foot 200 with an uncorrected hallux valgus deformity, while Figure 9B illustrates a aligned foot 200 corrected by the bone positioning guide 10. The solid line L1 represents the starting position of the bone positioning guide 10, and the dotted line L2 represents the ending position of the bone positioning guide. As shown, when the bone positioning guide 10 is activated, the bone positioning guide rotates with the first metatarsal bone 210 about an axis extending through the frontal plane, pushing the first metatarsal bone 210 laterally in the transverse plane and toward the sole in the sagittal plane. Therefore, in this example, the position of the first metatarsal bone 210 is corrected relative to the second metatarsal bone 292 in approximately three planes by activating a single bone positioning guide 10 to push the bone engagement member 40 toward the tip 50. Figure 10A shows a top view of a foot 200 with an uncorrected hallux valgus deformity, while Figure 10B shows a top view of the aligned foot 200 corrected by the bone positioning guide 10, highlighting rotational correction in the frontal plane and lateral correction in the transverse plane.

[0083] Figures 11A to 11C show three consecutive images of a bone positioning guide 10 on a foot 200 positioning the first metatarsal bone 210 relative to the second metatarsal bone 292. Figure 11A represents the start of the procedure, Figure 11B represents the procedure in progress, and Figure 11C represents the end of the procedure. The orientation of the pin 270 is useful for visualizing the amount of rotation of the first metatarsal bone 210 in each image. In Figures 11A to 11C, it can be seen that the bone positioning guide 10 and the first metatarsal bone 210 rotate in the frontal plane in response to the operation of the bone positioning guide 10. Furthermore, the angle between the first and second metatarsal bones decreases, as the space visible between the first and second metatarsal bones 210 and 292 in Figure 11A disappears in Figure 11C.

[0084] Each of the three potential planes of the deformity is described separately here. Figures 12A and 12B show frontal plane views of the foot 200. In Figure 12A, the foot 200 is normal, but in Figure 12B, the foot is illustrated with an uncorrected hallux valgus deformity showing isolated axial rotation of the first metatarsal bone 210. The solid line L3 indicates the alignment of the first metatarsal bone 210 with respect to the ground, and the dotted line L4 in Figure 12B indicates the range of axial rotation in the frontal plane.

[0085] Figures 13A and 13B show cross-sectional views of foot 200. In Figure 13A, foot 200 is normal, but in Figure 13B, the foot is illustrated with an uncorrected hallux valgus deformity showing displacement of the first metatarsal bone 210 in an isolated cross-section. The solid line L5 indicates the alignment of the second metatarsal bone 292, and the solid line L6 indicates the proper alignment of the first metatarsal bone 210 relative to the second metatarsal bone 292. The angle between these two lines forms the intermetatarsal angle (IMA). The dotted line L7 in Figure 13B indicates the range of displacement in the transverse direction.

[0086] Figures 14A and 14B show sagittal views of foot 200. In Figure 14A, foot 200 is normal, but in Figure 14B, the foot is shown with uncorrected hallux valgus deformity, exhibiting isolated sagittal displacement of the first metatarsal bone 210. The solid line L8 indicates the proper positioning of the first metatarsal bone 210, while the dotted line L9 in Figure 14B indicates the range of sagittal displacement.

[0087] A specific embodiment of the method according to an embodiment of the present invention includes the steps of engaging a bone engagement member with a first bone, positioning the tip of a bone positioning guide alongside a second bone different from the first bone, and moving the bone engagement member relative to the tip to change the position of the first bone relative to the second bone in two or more planes. In some embodiments, after alignment, at least one of the ends of the first bone and the opposing ends of the third bone (for example, only the end of the first bone or both the end of the first bone and the end of the second bone) is optionally prepared using a preparation guide.

[0088] In some embodiments, the method includes a step of moving the joint for corrective treatment. For example, after creating surgical access to the joint, tissue can be separated to allow bones such as metatarsals to rotate freely before moving the bones into alignment positions. In some embodiments, free rotation may be further facilitated by excising obstructing bone (e.g., dorsolateral flares of the metatarsal base, plantar flares of the metatarsal base (optionally referred to as plantar condyles), portions of the metatarsal ends opposite the cuneiforms, or osteophytes) to create a relatively flat surface with respect to the frontal plane. An example of a dorsolateral flare F on the first metatarsal 210 of the foot 200 is shown in Figure 15A. An example of a plantar flare PF on the first metatarsal 210 is shown in Figure 15B. Figure 15B also illustrates a medial ridge MR which can be engaged by a bone engagement member of a bone alignment guide in some embodiments.

[0089] Embodiments of the method according to the present invention may also include steps performed after the preparation of the bone ends. For example, the bone ends may be juxtaposed and optionally compressed together, and the bone positions may be fixed by one or more bone fixation devices (e.g., compression bone screws, bone plates, bone staples, external fixators, intramedullary implants or nails) before closing surgical access to the joint.

[0090] Exemplary methods are described here in relation to Figures 16-27, which illustrate a foot 200 having a first metatarsal bone 210, a medial cuneiform bone 220, and a second metatarsal bone 292. Note that unless otherwise specified, the steps described do not need to be performed in the order they are described.

[0091] Following conventional surgical preparation and surgical access, as shown in Figure 16, a bone reshaping instrument 296 is inserted into the joint (e.g., the first tarsal-metatarsal joint) to remove soft tissue and / or excise the plantar flare from the base of the first metatarsal bone 210. The excision of the plantar flare may involve cutting the plantar flare from the first metatarsal bone 210, so that the surface of the first metatarsal bone is generally planar. This step assists in moving the joint and promotes deformity correction. In some embodiments, the posterior lateral flare of the first metatarsal bone can also be excised to create space for deformity correction (e.g., for rotation of the first metatarsal bone). In certain embodiments, a portion of the metatarsal base opposite the medial cuneiform bone can be removed during this moving step.

[0092] An incision can be made, and the tip 50 of the bone positioning guide 10 can be inserted into the side of a metatarsal bone other than the first metatarsal bone 210, such as the second metatarsal bone 292. As shown in Figure 17, the tip can be positioned close to the contact surface between the base of the second metatarsal bone 292 and the third metatarsal bone 294. The surface of the bone engagement member 40 can be positioned on the proximal portion of the first metatarsal bone 210. In some embodiments, the bone engagement member engages with the medial ridge of the first metatarsal bone 210. As shown, the body 20 of the positioning guide may be approximately perpendicular to the long axis of the second metatarsal bone 292.

[0093] As shown in Figure 18, the actuator 120 can be operated to extend the shaft 30, thereby reducing the angle (the cross-sectional angle between the first and second metatarsals) and rotating the first metatarsal about its axis (frontal plane axial rotation). By moving the bone engagement member 40 relative to the tip 50, the first metatarsal 210 can be properly positioned relative to the medial cuneiform bone 220. In some embodiments, such movement simultaneously pivots the first metatarsal relative to the cuneiform bone to an anatomically correct position and rotates the first metatarsal about its longitudinal axis to correct cross-sectional and frontal plane deformations. In certain embodiments, the body 20 rotates roughly laterally during this process. In some embodiments, before the positioning step (for example, by hand or using the aperture in the guide as a template), a fixation pin (not shown in Figure 18) can be inserted into the bone to apply additional force (in transverse, sagittal, and / or frontal plane rotation) to the first metatarsal bone 210, if desired. The bone positioning guide 10 can hold the desired position of the first metatarsal bone 210 relative to the second metatarsal bone 292. After the desired correction is achieved, a fixation wire 298 can be inserted through the intubation in the shaft 30, driving the wire 298 into the first metatarsal bone 210 and the second metatarsal bone 292 to hold the corrected position.

[0094] As shown in Figure 19, the joint spacer 188 can be positioned within the joint between the first metatarsal bone and the medial cuneiform bone.

[0095] As shown in Figure 20, the bone adjustment guide 150 is placed on the joint spacer 188 and engages with the joint spacer to set the position and orientation of the bone adjustment guide relative to the joint. As shown, the bone adjustment guide 150 can be positioned proximal to the bone positioning guide 10, generally on the dorsal or dorsomedial surface, by aligning longitudinally with the long axes of the first metatarsal bone 210 and the medial cuneiform bone 220. In other embodiments, the spacer 188 is positioned after the guide 150 has been provisionally placed on the bone. In yet another embodiment, the bone adjustment guide 150 and the joint spacer 188 are placed simultaneously. In yet another embodiment, the bone adjustment guide 150 is placed on the bone without using the joint spacer 188 to assist in positioning.

[0096] As shown in Figures 21A and 21B, one or more fixing pins 270 can be inserted into the aperture of the bone preparation guide 150 to ensure guidance to the first metatarsal bone 210 and the medial cuneiform bone 220. As shown, several pins 270 can be inserted at angles or in converging directions that help prevent movement of the bone preparation guide 150 during the tissue removal process. As shown, two of the pins 270, i.e., one on the first metatarsal bone and one on the medial cuneiform bone, are parallel, and the bone preparation guide 150 can be removed from the foot without removing all the pins. After insertion of the pins 270, in embodiments having selectively engageable spacers (e.g., joint spacers 188 that can be physically removed from the bone preparation guide 150), the spacers 188 can be optionally removed.

[0097] In some embodiments, the location of intersection between the tissue removal instrument and the bone to be prepared is confirmed before bone preparation. In one embodiment, a tissue removal instrument positioning member can engage with the preparation guide to visually confirm the location where the tissue removal instrument will come into contact with the bone. In other embodiments, the tissue removal instrument is engaged with the preparation guide to visually confirm the location where the instrument will come into contact with the bone. In any embodiment, such visual confirmation may include the use of an imaging device such as an X-ray. If the preparation guide is correctly positioned, additional fixing pins can be inserted through an aperture (e.g., an angled aperture) to further fix the preparation guide in place relative to the first metatarsal bone and the medial cuneiform bone. In some embodiments, spacers are reinstalled before further bone preparation steps.

[0098] In some embodiments, the end of the first metatarsal bone 210 opposite the medial cuneiform bone 220 can be prepared with a tissue removal instrument 296 guided by the guide surface of a bone preparation guide 150 (inserted, for example, through a slot defined by the first guide surface and the first opposing surface). In some embodiments, the preparation of the end of the first metatarsal bone 210 is performed after bone alignment, for example, by activating the bone alignment guide 10 before preparing the end of the first metatarsal bone 210. In other embodiments, the preparation of the end of the first metatarsal bone 210 is performed before bone alignment, by preparing the end of the first metatarsal bone 210 before activating the bone alignment guide 10.

[0099] In addition, as shown in Figure 22, the end of the medial cuneiform bone 220 opposite the first metatarsal bone 210 can be prepared by a tissue removal instrument 296 guided by the guide surface of a bone preparation guide 150 (for example, inserted through a slot defined by a second guide surface and a second opposing surface). In some embodiments, the preparation of the end of the medial cuneiform bone 220 is performed after bone alignment. In yet another embodiment, the preparation of the end of the medial cuneiform bone 220 is performed before bone alignment. In embodiments involving cutting of bone or cartilage, the cuneiform and metatarsal cuts can be parallel and identical. In the specific embodiment shown in Figure 22, a saw blade can be inserted through a first slot to cut a portion of the medial cuneiform bone, and a saw blade can be inserted through a second slot to cut a portion of the first metatarsal bone (for example, in some embodiments, the medial cuneiform bone can be cut before the first metatarsal bone). Therefore, in the illustrated embodiment, the cutting of both the first metatarsal bone and the medial cuneiform bone was performed after the first metatarsal bone had been positioned.

[0100] Any angled / converging pins can be removed, and the bone alignment guide 150 can be lifted from the parallel pins 270, as shown in Figure 23. The parallel pins can be referred to as “reference pins” that can serve as references in subsequent processes to ensure that the corrected alignment of the first metatarsal bone 210 is maintained. The joint spacers can also be removed before, during, or at the same time as the bone alignment guides. In some embodiments, the bone positioning guides 10 are also removed from the foot.

[0101] Tissues originating from the first metatarsal and medial cuneiform bones (e.g., fragments of bone or cartilage) can be removed from the joint site, and the joint surface can be fenestrated if desired. If the bone positioning guide is removed from the foot, it can be reattached before the additional steps described later, as shown in Figure 24.

[0102] After preparation, the ends of the two bones can be juxtaposed and optionally compressed together by temporarily fixing the joint. For example, the two bones can be juxtaposed by positioning the cut end of the first metatarsal bone 210 in contact with the cut end of the medial cuneiform bone 220. In some examples, the cut end of the first metatarsal bone 210 is positioned adjacent to, and optionally in contact with, the cut end of the medial cuneiform bone 220.

[0103] As shown in Figure 25, a compression pin, such as a threaded olive pin 300, can be inserted through the first metatarsal bone 210 into the medial cuneiform bone 220 to provide compression and temporary fixation between the first metatarsal bone and the medial cuneiform bone. Additional compression pins may be inserted to provide further stability. As shown, a parallel reference pin needs to be aligned during this process. In some embodiments, the practitioner checks the alignment of the parallel reference pin before inserting the compression pin and, if the reference pin is not aligned, adjusts the position of the first metatarsal bone until the desired alignment is achieved.

[0104] While it is possible to leave parallel reference pins in place, in some embodiments the parallel reference pins and bone positioning guides can be removed, and a bone fixation device (e.g., two bone plates positioned in different planes, as shown) can be applied to stabilize the joint for fixation. Figure 26A shows a first bone plate 310 positioned dorsomedially on the first metatarsal and medial cuneiform bones, and a second bone plate 320 positioned medial plantarly on the first metatarsal and medial cuneiform bones. In other embodiments, such as the embodiment shown in Figure 26B, the second bone plate 320 may be a helical bone plate positioned across the joint cavity from the medial side of the cuneiform bone to the plantar side of the first metatarsal bone. The plates can be applied by inserting bone screws.

[0105] As shown in Figure 27, the compression pin can be removed and the incision can be closed.

[0106] Figures 28A / B and 29A / B include examples of anatomically misaligned metatarsals and metatarsals anatomically aligned using the method and / or apparatus according to the present invention. Figure 28A shows the left foot before and after treatment, and Figure 28B shows the right foot before and after treatment. The intermetatarsal angle (IMA) of the patient was significantly reduced so that the pre-treatment image can be understood by comparing it with the post-treatment image. Figures 29A and 29B show the correction of axial rotation in the frontal rotational plane. Figure 29A shows the pre-treatment and post-treatment images of the right foot. A drawing of the metatarsal bone 210 is also provided to illustrate the rotation. The rotation of the metatarsal bone can be understood by the position of the sesamoid bone 400, which is illustrated as rotated below the first metatarsal bone 210 in the post-treatment drawing. Figure 29B shows pre-treatment drawings of the left foot 200 and the right foot 200. In this case as well, by comparing the location of the sesamoid bones 400 to reference locations such as the ground, the sole surface of the foot, and / or the cuneiform bones, it can be understood that the metatarsals of this patient are displaced and rotated.

[0107] Methods according to embodiments of the present invention may be useful for temporarily positioning one or more bones. Bone positioning may be useful, for example, to correct anatomical misalignment of bones and to temporarily maintain an anatomically aligned position in bone alignment and / or fixation procedures. In some embodiments, “anatomically aligned position” means that the angle between the long axis of the first metatarsal bone and the long axis of the second metatarsal bone is about 10 degrees or less in the transverse or sagittal plane. In certain embodiments, anatomical misalignment can be corrected in both the transverse and frontal planes. In the transverse plane, the normal intermetatarsal angle ("IMA") between the first and second metatarsal bones is less than about 9 degrees. An IMA of about 9 to about 13 degrees is considered a mild misalignment of the first and second metatarsal bones. An IMA greater than about 16 degrees is considered a severe misalignment of the first and second metatarsal bones. In some embodiments, the method according to the present invention can anatomically align (multiple) bones by positioning the first metatarsal bone at a different angle relative to the second metatarsal bone, thereby reducing the IMA from more than 10 degrees (including a negative angle of about -5 degrees) to about 10 degrees or less (for example, to an IMA of about 1 to 5 degrees), or until it contacts the second metatarsal bone.

[0108] With respect to the frontal plane, a normal first metatarsal bone is positioned such that its crest is roughly perpendicular to the ground and / or its sesamoid bone is roughly parallel to the ground, and is located below the metatarsal bone. This position can be defined as a 0-degree metatarsal rotation. In a misaligned first metatarsal bone, the metatarsal bone is axially rotated by approximately 4 degrees to approximately 30 degrees or more. In some embodiments, the method according to the present invention can anatomically align the metatarsal bone by rotating it relative to the medial cuneiform bone, thereby reducing the metatarsal rotation from approximately 4 degrees or more to less than 4 degrees (e.g., approximately 0 degrees to 2 degrees).

[0109] While various embodiments of bone repositioning and bone reshaping guide systems and methods have been described, it should be understood that the concepts of this disclosure can actually be modified based, for example, on the needs of the clinician, the patient undergoing bone repositioning procedures, the specific biostructure being treated, and / or the target clinical outcome. As an example, the described systems and methods may be modified to utilize a lever. The rotation and / or pivot of one bone relative to another, centered on the lever, occurs via the bone repositioning guide 10. The lever can create and / or maintain space between adjacent bones compressed between the bone engagement member 40 and the tip 50 of the bone repositioning guide 10, thereby preventing lateral translation or base displacement of the bone during rotation and pivoting.

[0110] Figure 30A shows a portion of a foot with hallux valgus caused by the first metatarsal bone 210 being displaced relative to the second metatarsal bone 292. Figure 30B shows the foot of Figure 30A after being anatomically aligned to correct the displacement using the bone positioning guide 10. As shown, the first metatarsal bone 210 is rotated counterclockwise in the frontal plane (from the patient's perspective) (clockwise from the frontal observer's perspective) and pivoted in the transverse plane (for example, so that the angle 350 between the first metatarsal bone 210 and the second metatarsal bone 292 is reduced). The rotation and pivot of the first metatarsal bone 210 can displace the base 352 of the first metatarsal bone 210 relative to the medial cuneiform bone 220. Generally, it is desirable that the offset 354A between the first metatarsal bone 210 and the medial cuneiform bone 220 be reduced to zero after the rotation and pivot (for example, so that the offset is substantially eliminated). However, as shown in the application described in Figure 30B, the base 352 of the first metatarsal bone 210, which is in contact with the medial cuneiform bone 220, is displaced toward the second metatarsal bone 292. This results in a transverse offset 354B of the first metatarsal bone 210 toward the second metatarsal bone 292, causing compression of the base between the first metatarsal bone 210 and the second metatarsal bone 292.

[0111] To avoid the base displacement and offset 354B observed in Figure 30B, the clinician can insert a lever into the notch between the first metatarsal 210 and the second metatarsal 292 at the base of the metatarsal bones (e.g., each adjacent cuneiform bone) before activating the bone positioning guide 10. The lever can minimize or avoid base compression between the first and second metatarsal bones while providing a point where the first metatarsal 210 can rotate and / or pivot around it. In addition, the use of the lever allows the first metatarsal 210 and the medial cuneiform 220 to be angled better with respect to the guide slot of the bone preparation guide 150 (once in place), and then a better cutting angle can be obtained through the guide slot without using the lever. This reduces or eliminates unwanted rebound or return of the first metatarsal 210 after removal of the bone positioning guide 10.

[0112] Figure 31 shows a bone positioning procedure in which a lever 356 is positioned at the intersection between the first and second bones, where the first bone is being repositioned relative to the second bone. In particular, Figure 31 shows a lever 356 positioned between the first metatarsal bone 210 and the second metatarsal bone 292. The lever 356 may be positioned distal to the bone adjustment guide 150 between the first metatarsal bone 210 and the second metatarsal bone 292, as shown in Figure 31, or, in other applications, proximal to the guide (for example, at the ends of the first and second metatarsals that are in contact with the medial cuneiform and intermediate cuneiform bones, respectively).

[0113] During use, the clinician may insert the lever 356 between the first metatarsal 210 and the second metatarsal 292 (or other adjacent bones if metatarsal repositioning is not performed) at any time before activating the bone positioning guide 10. In different embodiments, the lever 356 may be inserted between the first metatarsal 210 and the second metatarsal 292 before or after inserting the joint spacer 188 and / or before or after placing the bone preparation guide 150 over the joint being treated. In one embodiment, the clinician prepares the joint being treated by removing soft tissue and / or excising the plantar flare from the base of the first metatarsal 210, as described above. Either before or after the bone positioning guide 10 is placed on an adjacent bone, for example, if the bone engagement member 40 is positioned in contact with the medial crest of the first metatarsal bone 210 and the tip 50 is positioned in contact with the second metatarsal bone 292, the clinician inserts the lever 356 at the joint between the first and second metatarsal bones. The clinician can then operate the bone positioning guide 10 (for example, by rotating the knob 120). As shown in Figure 31, in the case of the left foot, operation of the bone positioning guide 10 rotates the first metatarsal bone 210 counterclockwise in the frontal plane (from the patient's perspective) and pivots it around the lever in the transverse plane. In the case of the right foot (not shown), operation rotates the first metatarsal bone clockwise in the frontal plane (from the patient's perspective) and pivots it around the lever in the transverse plane. Therefore, for both feet, the operation of the bone positioning guide 10 allows the first metatarsal bone to be supinated in the frontal plane and pivoted around the lever 356 in the transverse plane. The use of the lever 356 minimizes or eliminates base compression between adjacent bones during treatment, while in other embodiments described above, the system and technique can be performed without using the lever.

[0114] In cases where the lever base 356 is used, any suitable mechanical instrument can be used as the lever base. Figure 32 is a perspective view of one exemplary instrument that can be used as the lever base 356. In this embodiment, the lever base 356 has a generally rectangular shape and is tapered in thickness along at least a portion of the length from the end portion 358 to the tip portion 360. The lever base 356 can be sized small enough not to interfere with the placement of the bone adjustment guide 150 over the joint being worked on. In some embodiments, a system containing several different sizes of lever bases is provided, and the clinician can select the specific size of lever base desired for the particular procedure being performed. Figure 33 shows an exemplary kit or system of different sized lever bases, labeled with exemplary “width × thickness” dimensions, which can be provided to a clinician in such embodiments. In some examples, lever bases with different dimensions can be used, but the lever base 356 has a width in the range of 5 mm to 15 mm (e.g., about 6 mm to about 10 mm) and a thickness in the range of 1 mm to 12 mm (e.g., about 2 mm to about 3 mm). While Figures 32 and 33 show exemplary styles of levers, other mechanical instruments can be used to provide the functionality of a lever without departing from the scope of this disclosure. For example, as an alternative example, a surgical pin or screwdriver head can be used as the lever 356.

[0115] As described above, the bone positioning guide 10 can have a variety of different configurations, including one in which the bone engagement member 40 is laterally offset from the tip 50. Figure 34 is a perspective view of the bone positioning guide 10 showing an exemplary arrangement in which the bone engagement member 40 is laterally offset from the tip 50. In this embodiment, the first end 60 of the main body member 20 is laterally offset from the axis 362 extending through the geometric center of the shaft 30 and the bone engagement member 40. In particular, in the illustrated configuration, the tip 50 is laterally offset relative to the bone engagement member 40 in the direction of the wedge bone. As a result, when the bone positioning guide 10 is actuated, for example by rotating the knob 120, the offset tip can generate a moment. This allows the end of the first metatarsal bone 210 adjacent to the proximal phalanx to pivot toward the second metatarsal bone 292, for example, reducing the angle 350, while the opposite end of the first metatarsal bone adjacent to the medial cuneiform bone pivots toward the second metatarsal bone. This can also help avoid compression of the base between the first and second metatarsals.

[0116] As described above with respect to Figures 19 and 20, the joint spacer 188 can be positioned within the joint between the first metatarsal bone and the medial cuneiform bone before the bone adjustment guide 150 is placed on top of the joint spacer. The bone adjustment guide 150 may have an opening 170 (Figure 5) sized to receive the joint spacer 188. In some examples, (when the bone adjustment guide 150 is placed on top of the joint spacer 188,) the opening 170 of the bone adjustment guide 150 is sized and / or shaped according to the joint spacer 188 such that there is substantially no or no relative movement between the guide and the spacer. This placement ensures that the bone adjustment guide 150 is precisely positioned in the location guided by the joint spacer 188.

[0117] In practice, when the bone positioning guide 150 is placed on the joint spacer 188, the guide slot of the bone positioning guide cannot be perfectly aligned with the ends of the bones being cut through the guide slot (e.g., the first metatarsal bone 210 and the medial cuneiform bone 220). Therefore, in other configurations, the opening 170 of the bone positioning guide 150 may be sized and / or shaped according to the joint spacer 188. In other words, the opening 170 of the bone positioning guide 150 may have a different cross-sectional size and / or cross-sectional shape from that of the joint spacer 188. In these configurations, the bone positioning guide 150 can actuate or rotate about an axis extending through the length of the joint spacer 188. As a result, after the clinician places the bone preparation guide 150 on the joint spacer 188, the clinician can rotate the bone preparation guide 150 around the joint spacer 188 until the guide slot of the bone preparation guide is better aligned with the ends of the bone to be cut (e.g., the first metatarsal bone 210 and the medial cuneiform bone 220). Depending on the configuration of the opening 170 of the bone preparation guide 150 and the configuration of the joint spacer 188, the guide can rotate freely (e.g., 360 degrees) around the joint exploration device within a bounded angular range (e.g., +20 degrees to -20 degrees from the normal position).

[0118] Figure 35 shows an exemplary configuration with an articular spacer 188 that allows the bone preparation guide 150 to rotate around the exploration device. As shown in the illustrated example, the articular spacer 188 has a proximal portion 370 having a cylindrical cross-section and a distal portion 372 having a rectangular cross-section. The tip of the distal portion 372 is insertable into the articular joint between the first metatarsal bone 210 and the medial cuneiform bone 220. When the bone preparation guide 150 is inserted onto the articular spacer 188, the body of the guide 154 (Figure 5) can be positioned around the proximal portion 370. This allows the guide to rotate around the proximal portion.

[0119] In other configurations, the opening 170 of the bone positioning guide 150 can be sized and / or shaped according to the cross-sectional size and / or shape of the joint spacer 188, but relative rotation between the two components is still possible. For example, the opening 170 may have a cross-sectional size and / or shape that accommodates the proximal portion 370 of the joint spacer 188 in Figure 35. In such an embodiment, since the opening 170 of the bone positioning guide 150 and the proximal portion 370 of the joint spacer 188 have circular cross-sections, the two components can rotate relative to each other. Figure 36A is a perspective view of an exemplary configuration of the bone positioning guide 150 having an opening 170 with a circular cross-sectional shape. Figure 36B is a perspective view of the exemplary bone positioning guide of Figure 36A shown with the joint spacer 188 of Figure 35 inserted into the guide.

[0120] In embodiments in which the bone positioning guide 150 can rotate relative to the articular spacer 188, the bone positioning guide and / or articular spacer may be provided with a locking mechanism that can be engaged to lock the rotation angle of the bone positioning guide relative to the articular spacer. For example, the bone positioning guide 150 may include a positioning screw having a rotatable rotary dial, the distal end of which can be retracted in a direction that loads the articular spacer 188 or moves it away from the articular spacer 188. When in use, the clinician can rotate the bone positioning guide 150 around the articular spacer 188 until the guide slot of the bone positioning guide is best aligned with the end of the bone to be cut (e.g., the first metatarsal bone 210 and the medial cuneiform bone 220). The clinician can then engage the locking mechanism to prevent further rotation of the bone positioning guide 150 relative to the articular spacer 188 before performing further steps of the procedure.

[0121] Embodiments of the present invention also include a disposable sterile kit comprising embodiments of the bone positioning guide and / or preparation guide described herein. Other components that may be included in the sterile kit include a bone fixation device.

[0122] Embodiments of the present invention are thus disclosed. Although the present invention has been described with reference to certain disclosed embodiments, the disclosed embodiments are presented for illustrative purposes only and not for limiting purposes, and other embodiments of the present invention are possible. Those skilled in the art will understand that a variety of modifications, alterations, and changes can be made without departing from the spirit of the present invention.

Claims

1. 1. A bone positioning guide for hallux valgus correction surgery, comprising: a bone engaging member configured to engage a first metatarsal bone of the foot; a tip spaced from the bone engaging member a distance effective to position the tip on a lateral side of a second metatarsal and within a metatarsal gap between the second and third metatarsals; a mechanism operable to decrease a distance between the bone engaging member and the tip, thereby moving the first metatarsal bone at least in a horizontal plane to decrease an intermetatarsal angle between the first metatarsal bone and the second metatarsal bone; 1. A bone positioning guide comprising:

2. The mechanism comprises: moving the bone engaging member toward the tip; moving the tip towards the bone engaging member; moving both the bone engaging member and the tip towards each other; The bone location guide of claim 1 , wherein the bone location guide is operable to:

3. The bone location guide of claim 1 or 2, wherein the bone engaging member defines a cannulation, the cannulation being configured to allow a fixation wire to be inserted through the cannulation.

4. The bone location guide of claim 1 , further comprising a stop configured to limit the depth of insertion of the tip.

5. The bone location guide of claim 1 , wherein the bone engaging member is configured to contact a medial side of the first metatarsal bone.

6. The bone location guide of claim 1 , wherein the bone engaging member is a flat surface.

7. The bone location guide of claim 1 , wherein the bone engaging member defines a concave surface configured to face a medial side of the first metatarsal bone.

8. The bone location guide of claim 1 , wherein the tip defines a concave shape configured to face a lateral side of the second metatarsal bone.

9. 9. The bone location guide of claim 1, wherein the bone location guide is made of at least two components that are joined together to form the bone location guide.

10. 10. The bone location guide of any one of claims 1 to 9, made from a radiolucent material.

11. The bone positioning guide of claim 1 , wherein the mechanism comprises one or more of a threaded shaft, a rack and pinion, and a sliding connection.

12. The bone location guide of claim 1 , further comprising an actuator configured to actuate the mechanism.

13. The bone location guide of claim 12 , wherein the actuator comprises barb or tong structures configured to be urged together to actuate the mechanism.

14. 14. The bone location guide of claim 1, further comprising a body member, the bone engaging member being positioned on one side of the body member and the tip being positioned on an opposite side of the body member.

15. the body member defines a base, a first leg carrying the bone engaging member, and a second leg defining the tip; the base extends in a medial-lateral direction across a dorsal surface of the first metatarsal and across a dorsal surface of the second metatarsal; the first leg extends downwardly from the base to position the bone engaging member on a medial side of the first metatarsal; The second leg extends downward from the base and has the tip positioned on the lateral side of the second metatarsal bone. The bone location guide of claim 14.

Images