Bone manipulator and use of the same

Abstract

Provided herein are methods, devices and systems for fixating a bone multi-axially and manipulating the multi-axially fixated bone. In some embodiments, the device includes a main body configured to receive a plurality of wires configured to be inserted into the bone. The device is configured to provide multi-axial fixation of the bone by at least a first wire inserted into the bone in a first direction and at least a second wire inserted into the bone in a second direction. In some embodiments, the method includes advancing the first wire through a first wire guide in the first direction along a first axis, and advancing the second wire through a second wire guide in the second direction along a second axis that is generally perpendicular to the first axis.

Description

BONE MANIPULATOR AND USE OF THE SAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 692,307, filed on September 9, 2024, which is incorporated herein by reference in its entirety.FIELD OF INVENTION

[0002] This invention relates to devices, systems, and methods to assist with manipulation of bones during fracture surgery and reconstructive foot procedures.BACKGROUND OF THE INVENTION

[0003] The calcaneus (heel bone) is the largest of the tarsal bones in the foot. It lies at the back of the foot (hindfoot) below the three bones that make up the ankle joint. A calcaneal / calcaneus fracture is a break of the calcaneus. When someone breaks their calcaneus, part of the difficulty is pulling the posterior portion of the bone (posterior tuberosity) back to its original position before the break. Positioning the posterior tuberosity of the calcaneus during fracture fixation or foot reconstructive procedures requiring calcaneal osteotomies is one of the most crucial and most difficult steps of the case. Manipulating the posterior tuberosity is difficult because it is a small fragment of bone which is primary cancellous (soft) bone so uniplanar fixation often pulls out of the bone or deforms the bone fragments. For example, a calcaneal fracture fixation or open reduction and internal fixation procedure is used to correct a severe fracture of the calcaneus. During this procedure, the surgeon stabilizes the bone with hardware to allow the bone to heal properly. Sometimes, a large pin is put into the posterior tuberosity, but it puts a large hole in the skin and can loosen up. At times, surgeons will connect this to an external fixator.

[0004] Currently, an external fixator or a bone distraction device is placed when fixing calcaneus fractures. These devices are problematic because they require placement of hardware in the posterior tuberosity of the calcaneus and another bone. They only involve a single screw or Kirschner wire to manipulate the bone fragments which frequently bends and can get in the way of the surgeon during the rest of the procedure. For example, a T-Handle is a handheld tool that is used to hand tighten the wires placed into the posterior tuberosity during orthopedic surgery. It is often used to then provide a better grip to manipulate the bone but can get in the way. Many of these devices, like a medial based external fixator, are problematic because they are complicated and require special positioning of the patient so that the device does not 4937-3900-1 173.4 065472-000978WOPTpuncture the drapes that are employed to provide a physical barrier that protects the surgical field from contamination. For manipulation of calcaneal osteotomies, there are no products, and surgeons often must try and pull the bone by hand through the skin and fix it temporarily with Kirshner wires. With increasing use of minimally invasive osteotomy techniques, this becomes even more challenging.

[0005] Therefore, there is a need for a simple, easy-to-use device that will improve the pullout strength when trying to manipulate a fracture or osteotomy fragment of calcaneus posterior tuberosity. There is also a need for a manipulator device suitable for minimally invasive calcaneal osteotomies. However, many prior distraction devices are complicated, time consuming and only provide uniplanar fixation, and thus, they are not used by most surgeons. The present disclosure provides a solution for these and other problems.SUMMARY OF THE INVENTION

[0006] To solve these problems, described herein is a device or manipulator that allows for multi-axial fixation of the posterior tuberosity for improved strength and has a handle that provides a biomechanical advantage during manipulation. The device can be manipulated to manipulate or move part of the calcaneus when there is a fracture, or when an osteotomy has been created. The handle is more ergonomic than a pin with a T handle chuck placed. This device may be radiolucent to prevent obstruction of fluoroscopic imaging during surgery. This device may have various k wire sleeves or guides to allow multiple sizes to be used in the manipulator. The device may also have set screws that come in perpendicular to the k wire channels to lock in place. This device will help surgeons pull the bone back into place to allow them to then put screws or a plate and screws to keep the bone in place. Further, the device may have attachments for connection to an external fixator or distraction device. The device may also be used to pull on the posterior tuberosity after performing a calcaneus osteotomy. In these situations, surgeons cut the heel bone and then translate it medially or laterally to correct deformity in the foot. Recently, this technique has become a minimally invasive technique, but the hardest part of the procedure is moving the heel bone after it is cut. The inventive device can be used to move the heel bone by using the minimally invasive technique.

[0007] The device may be a single use device readily available on the shelf. Thus, surgeons may simply open a package to use the device when performing calcaneal open reduction internal fixation or during calcaneal osteotomies, in particular, minimally invasive osteotomies.

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with devices, systems, and methods, which are meant to be exemplary and4937-3900-1 173.4065472-000978WOPTillustrative, not limiting in scope.

[0009] Provided herein are various embodiments of a device for manipulating a bone. In various embodiments, the device includes a main body configured to receive a plurality of wires configured to be inserted into the bone. The device is configured to provide multi-axial fixation of the bone by at least a first wire of the plurality of wires inserted into the bone in a first direction and at least a second wire of the plurality of wires inserted into the bone in a second direction, a first axis along the first direction intersecting with a second axis along the second direction at a point.

[0010] In some embodiments, the first axis is generally perpendicular to the second axis.

[0011] In some embodiments, the device is configured such that a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the first wire and the second wire inserted into the bone.

[0012] In some embodiments, the bone comprises calcaneus.

[0013] In some embodiments, the main body comprises a first arm and a second arm diverging from a base of the main body.

[0014] In some embodiments, a through hole is formed on the base.

[0015] In some embodiments, the through hole is configured to receive an external fixator attachment.

[0016] In some embodiments, the external fixator attachment is configured to be connected to an external fixator or a bone distraction device.

[0017] In some embodiments, the external fixator attachment is a curved rod.

[0018] In some embodiments, the external fixator attachment includes a hexagonal portion configured to be inserted into the through hole having a hexagonal shape.

[0019] In some embodiments, the external fixator attachment further includes a threaded end portion extending from the hexagonal portion.

[0020] In some embodiments, the external fixator attachment is configured to be stably coupled to the main body by a fastener or wing nut releasably couplable to the threaded end portion of the external fixator attachment inserted into the through hole.

[0021] In some embodiments, the base has a curved portion such that the first arm and the second arm that extend from the base in different directions are angled or generally perpendicular.

[0022] In some embodiments, the main body further comprises a handle.

[0023] In some embodiments, the handle is connected to the base via a bridge located between the handle and the base.4937-3900-1 173.4065472-000978WOPT

[0024] In some embodiments, the bridge extends from a middle portion of the handle towards the base.

[0025] In some embodiments, the connected handle and bridge has a generally T shape.

[0026] In some embodiments, the connected bridge and base with the first arm and the second arm extending therefrom has a generally Y shape.

[0027] In some embodiments, the first arm is generally perpendicular to the second arm.

[0028] In some embodiments, a first end of each of the first arm and the second arm is connected to the base.

[0029] In some embodiments, each of the first arm and the second arm has a receiving portion formed at a second end of the first or second arm, the receiving portion being configured to receive at least one of the plurality of wires.

[0030] In some embodiments, each of the first arm and the second arm is enlarged generally progressively from the first end towards the second end.

[0031] In some embodiments, the receiving portion has a front side having a generally rectangular shape, two parallel vertical sides extending from the front side, and two parallel horizontal sides extending from the front side.

[0032] In some embodiments, the front side of the receiving portion of the first arm and the front side of the receiving portion of the second arm are biplanar.

[0033] In some embodiments, the receiving portion has at least one slot configured to receive a wire guide, the at least one slot having a channel formed through the two parallel vertical sides.

[0034] In some embodiments, a length of the wire guide is about 60 mm.

[0035] In some embodiments, the number of slots in each receiving portion is 1, 2, or 3, each slot being configured to receive a wire guide.

[0036] In some embodiments, at least one slot of the first arm is elongated along the first axis, and the at least one slot of the second arm is elongated along the second axis.

[0037] In some embodiments, at least one slot of the first arm is perpendicular to at least one slot of the second arm.

[0038] In some embodiments, a length of at least one slot is about 25 mm, and a diameter of a channel formed at the at least one slot is about 6 mm.

[0039] In some embodiments, the wire guide is configured to receive and / or guide a wire, the wire being one of the plurality of wires.

[0040] In some embodiments, the wire comprises a Kirschner wire or K-wire.

[0041] In some embodiments, the wire guide is interchangeable, the interchangeable wire4937-3900-1 173.4065472-000978WOPTguides being configured to receive various sizes of wires.

[0042] In some embodiments, the receiving portion further has at least one threaded hole, the at least one threaded hole being formed through one of the two parallel horizontal sides into one of the at least one slot.

[0043] In some embodiments, each of the at least one threaded hole is configured to receive a fastener for holing a wire received by the wire guide.

[0044] In some embodiments, the fastener includes a head and a threaded shank that is inserted into the at least one threaded hole, the head being shaped to be grabbed by fingers and not insertable into the at least one threaded hole.

[0045] In some embodiments, at least one slot in each receiving portion is two, and at least one threaded hole in each receiving portion is two.

[0046] In some embodiments, at least one threaded hole includes a first threaded hole formed into a first slot of at least one slot and a second threaded hole formed into a second slot of at least one slot.

[0047] In some embodiments, the first threaded hole is configured receive a first fastener configured to secure a first wire guide inserted into the first slot, and the second threaded hole is configured to receive a second fastener configured to secure a second wire guide inserted into the second slot.

[0048] In some embodiments, the first wire guide is configured to receive the first wire, and the second wire guide is configured to receive the second wire.

[0049] Also provided herein are various embodiments of a method for multi-axial fixation of a bone of a subject to manipulate the bone. In various embodiments, the method includes: advancing a first wire through a first wire guide in a first direction along a first axis, the first wire being put into a first target point of the bone; and advancing a second wire through a second wire guide in a second direction along a second axis that is generally perpendicular to the first axis, the second wire being put into a second target point of the bone. The first wire and the second wire put into the bone are generally perpendicular.

[0050] In some embodiments, the bone includes calcaneus or posterior tuberosity.

[0051] In some embodiments, each of the first wire guide and the second wire guide is available in various sizes to accommodate various sizes of wires, and the first wire guide or the second wire guide is interchangeable with a different first or second wire guide having a different size.

[0052] In some embodiments, a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the first wire and the second wire put into the bone.

[0053] In some embodiments, the method further includes: inserting the first wire guide into a4937-3900-1 173.4065472-000978WOPTfirst receiving portion of a bone manipulator; and inserting the second wire guide into a second receiving portion of the bone manipulator.

[0054] In some embodiments, the method further includes: inserting a third wire guide into the first receiving portion of the bone manipulator; inserting a fourth wire guide into the second receiving portion of the bone manipulator; advancing a third wire through the third wire guide in the first direction, the third wire being put into a third target point of the bone; and advancing a fourth wire through the fourth wire guide in the second direction, the fourth wire being put into a fourth target point of the bone.

[0055] In some embodiments, the first wire guide is inserted into a first slot of the first receiving portion; the second wire guide is inserted into a second slot of the second receiving portion; the third wire guide is inserted into a third slot of the first receiving portion; and the fourth wire guide is inserted into a fourth slot of the second receiving portion.

[0056] In some embodiments, the first wire and the third wire put into the bone are generally parallel, and the second wire and the fourth wire put into the bone are generally parallel.

[0057] In some embodiments, the method further includes: inserting a first fastener into a first threaded hole of the first receiving portion to secure the first wire guide in the first slot; inserting a second fastener into a second threaded hole of the second receiving portion to secure the second wire guide in the second slot; inserting a third fastener into a third threaded hole of the first receiving portion to secure the third wire guide in the third slot; and inserting a fourth fastener into a fourth threaded hole of the second receiving portion to secure the fourth wire guide in the fourth slot.

[0058] In some embodiments, the method further includes positioning the multi-axially fixated bone by manipulating a handle of the bone manipulator.

[0059] In some embodiments, the handle is connected to a curved base of the bone manipulator via a bridge; a first arm and a second arm diverge from the base, the first arm being generally perpendicular to the second arm; and the first receiving portion is formed at one end of the first arm, and the second receiving portion is formed at one end of the second arm.

[0060] Also provided herein are various embodiments of a method for manipulating calcaneus of a subject. In various embodiments, the method includes: advancing a plurality of first wires through a plurality of first wire guides positioned through a plurality of first slots in a first direction along a first axis, the plurality of first slots formed at a first receiving portion of a first arm of a calcaneus manipulator; inserting the plurality of first wires into a plurality of first target points of the bone; and advancing a plurality of second wires through a plurality of second wire guides positioned through a plurality of second slots in a second direction along a4937-3900-1 173.4065472-000978WOPTsecond axis that is generally perpendicular to the first axis, the plurality of second slots formed at a second receiving portion of a second arm of the calcaneus manipulator; and inserting the plurality of second wires into a second target point of the bone. The plurality of first wires inserted into the bone are generally parallel. The plurality of second wires inserted into the bone are generally parallel. The plurality of first wires and the plurality of second wires inserted into the bone are generally perpendicular.

[0061] In some embodiments, the method further includes: inserting a plurality of first fasteners into a plurality of first threaded holes of the first receiving portion to secure the plurality of first wire guides in the plurality of first slots; and inserting a plurality of second fasteners into a plurality of second threaded holes of the second receiving portion to secure the plurality of second wire guides in the plurality of second slots.

[0062] In some embodiments, the method further includes positioning or manipulating the calcaneus multi-axially fixated by the calcaneus manipulator by holding a handle of the calcaneus manipulator.

[0063] In some embodiments, the handle is connected to a curved base of the calcaneus manipulator via a bridge; the first arm and the second arm diverging from the base are generally perpendicular; and the first receiving portion is formed at one end of the first arm, and the second receiving portion is formed at one end of the second arm.

[0064] In some embodiments, no bones other than the calcaneus needs to be fixated for multi- axial fixation of the calcaneus and / or manipulation of the calcaneus.

[0065] In some embodiments, the method is performed by using minimally invasive osteotomy techniques.

[0066] In some embodiments, the method is suitable for minimally invasive calcaneal osteotomies.

[0067] Also provided herein are various embodiments of a system for manipulating a bone. In various embodiments, the system includes: a main body including a first arm and a second arm diverging from a base of the main body, the base having a curved or angled portion such that the first arm and the second arm extending from the base are angled. The main body further includes a handle connected to the base via a bridge located between the handle and the base such that the connected handle and bridge has a generally T shape, and the connected bridge and base with the first arm and the second arm extending therefrom has a generally Y shape. The system further includes a plurality of wire guides receivable through a plurality of slots formed at a first receiving portion formed at one end of the first arm and at a second receiving portion formed at one end of the second arm; and a plurality of wires configured to pass through4937-3900-1 173.4065472-000978WOPTthe plurality of wire guides and to be inserted into the bone. The system is configured to provide multi-axial fixation of the bone by at least a plurality of first wires of the plurality of wires inserted into the bone in a first direction and at least a plurality of second wires of the plurality of wires inserted into the bone in a second direction, a first axis along the first direction intersecting with a second axis along the second direction at a point.

[0068] In some embodiments, the handle is configured to be held by a hand of an operator manipulating the multi-axially fixated bone.

[0069] In some embodiments, the bone comprises calcaneus.

[0070] In some embodiments, the plurality of wire guides are available in various sizes to accommodate various sizes of wires.

[0071] In some embodiments, diameters of the wires are in the range of 0.8 mm -3 mm, including 0.9 mm, 1.1 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.8 mm, 2 mm, 2.2 mm, 2.3 mm, and 2.5 mm, and / or lengths of the wires are in the range of 80 mm -250 mm, including 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, and 225 mm.

[0072] In some embodiments, the plurality of wire guides are interchangeable with different wire guides having a different size.

[0073] In some embodiments, diameters of channels of the plurality of wire guides are in the range of 0.8 mm - 3 mm, including 2 mm or about 2 mm, and / or lengths of the plurality of wire guides are in the range of 40 mm - 60 mm, including 60 mm or about 60 mm.

[0074] In some embodiments, a length of each of the plurality of slots is about 25 mm or 25 mm, and a diameter of a channel of each slot is about 6 mm or 6 mm.

[0075] In some embodiments, the system further includes an external fixator attachment configured to be connected to an external fixator or a bone distraction device.

[0076] In some embodiments, the external fixator attachment is a curved rod and inserted into a through hole formed on the base.

[0077] In some embodiments, the external fixator attachment includes a hexagonal portion configured to be inserted into the through hole having a hexagonal shape.

[0078] In some embodiments, the external fixator attachment further includes a threaded end portion extending from the hexagonal portion.

[0079] In some embodiments, the system further includes a fastener or wing nut configured to be releasably coupled to the threaded end portion of the external fixator attachment inserted into the through hole to stably couple the external fixator attachment to the main body.

[0080] In some embodiments, a receiving hole is formed at the hexagonal portion of the external fixator attachment.4937-3900-1 173.4065472-000978WOPT

[0081] In some embodiments, the system further includes a fastener configured to be inserted into the receiving hold to secure the external fixator attachment to the base.

[0082] In some embodiments, both the receiving hole and the fastener are threaded.BRIEF DESCRIPTION OF DRAWINGS

[0083] Exemplary embodiments are illustrated in the referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

[0084] FIG. 1 depicts, in accordance with various embodiments of the present invention, a top down / axial view of a calcaneal manipulator.

[0085] FIG. 2 depicts, in accordance with various embodiments of the present invention, a side / sagittal view of a calcaneal manipulator.

[0086] FIG. 3A depicts, in accordance with various embodiments of the present invention, a perspective view of a main body of a biplanar calcaneal manipulator.

[0087] FIG. 3B depicts, in accordance with various embodiments of the present invention, a different perspective view of a main body of a biplanar calcaneal manipulator.

[0088] FIG. 4 depicts, in accordance with various embodiments of the present invention, an interchangeable wire guide of a calcaneal manipulator.

[0089] FIG. 5A depicts, in accordance with various embodiments of the present invention, an external fixator attachment of a calcaneal manipulator, in particular, a rod with a hex and a threaded end.

[0090] FIG. 5B depicts, in accordance with various embodiments of the present invention, an external fixator attachment of a calcaneal manipulator, in particular, a wing nut configured to be coupled to the threaded end of the rod.

[0091] FIG. 6 depicts, in accordance with various embodiments of the present invention, various parts of a disassembled biplanar calcaneal manipulator.

[0092] FIG. 7 depicts, in accordance with various embodiments of the present invention, a top view of a calcaneal manipulator with interchangeable wire guides coupled thereto.

[0093] FIG. 8 depicts, in accordance with various embodiments of the present invention, a perspective view of a calcaneal manipulator with interchangeable wire guides and an external fixator attachment coupled thereto.4937-3900-1 173.4065472-000978WOPTDETAILED DESCRIPTION OF THE INVENTION

[0094] All references cited herein are incorporated by reference in their entirety as though fully set forth. Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0095] One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described. For purposes of the present invention, the following terms are defined below.Devices and Systems

[0096] Provided herein are various embodiments of a device or system for manipulating a bone. For example, as exemplified in FIGS. 1 and 2, the bone 150 may be calcaneus. However, the bone is not limited to calcaneus, and the bone may be any types of bones that can be fixated and manipulated with the inventive device or system. Referring to FIG. 1, in various embodiments, the device includes a main body 110. In various embodiments, the system 100 may include the main body 110, an external fixator attachment 120 attachable to the main body 110, interchangeable wire guides 130, and wires 140. According to the example shown in FIGS. 1 and 2, two wires 140 are put into a first target point of the bone 150 in a first direction along a first axis, and two wires 140 are put into a second target point of the bone 150 in a second direction along a second axis, using the device or main body 110 and the wire guides 130. Thus, the bone 150 is multi-axially fixated by the system 100. For example, the first axis and the second axis are generally perpendicular.

[0097] For example, the wire 140 may be a Kirschner wire or K-wire. In some embodiments, the system 100 is configured such that a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the wires 140 put in the first direction and the wires put in the second direction.

[0098] The structure of the main body 110 is discussed referring to FIGS. 3 A and 3B. In various embodiments, the main body 110 may include a handle 111, a bridge 112 extending from the handle 111, and a base 113 connected to the bridge 112. The handle 111 is elongated along axis A, and the bridge 112 is elongated along axis B such that the connected handle 111 and bridge 112 has a generally T shape. For example, axis A is perpendicular to axis B. In various embodiments, the bridge 112 may extend from a generally middle portion of the handle4937-3900-1 173.4065472-000978WOPT111. The base 113 may have a curved portion such that the base 113 is angled. In various embodiments, the base 113 diverges into two directions such that a pair of arms 114 extend from the base 113. The pair of arms 114 are shaped symmetrically with respect to the base 113. One of the arms 114 is elongated along axis C, and another one of the arms 114 is elongated along axis D. For example, axis C is perpendicular to axis D. In various embodiments, a size of each arm 114 may increase progressively from a first end connected to the base 113 towards a second end away from the first end. Thus, in various embodiments, a portion of the arm 114 that is farther from the base 113 is bigger compared to a portion of the arm 114 that is closer to the base 113. In some embodiments, a through hole 115 is formed on the base 113. The external fixator attachment 120 may be inserted into the through hole 115.

[0099] In various embodiments, each arm 114 has a receiving portion 116 formed at one end thereof (second end) that is farthest from the base 113. In various embodiments, the receiving portion 116 has a front side having a generally rectangular shape, two parallel vertical sides extending from the front side, and two parallel horizontal sides extending from the front side. The front side of the receiving portion 116 of one of the pair of arms 114, i.e., a first arm, and the front side of the receiving portion 116 of the other one of the pair of arms 114, i.e., a second arm, are biplanar. In various embodiments, the receiving portion 116 has at least one slot 117 formed through the two parallel vertical sides. For example, as shown in FIGS. 3 A and 3B, the at least one slot 117 of the first arm 114 is elongated along axis E and the at least one slot 117 of the second arm 114 is elongated along axis F. For example, Axis E is perpendicular to axis F. In some embodiments, axis D and axis E are parallel, and axis F and axis C are parallel. In FIGS. 3Aand 3B, there are two slots 117 formed at each receiving portion 116 of the first or second arm 114. However, the number of the slots 117 is not limited to two, as exemplified in FIGS. 3 A and 3B, and the number may be less than or greater than two in some embodiments.

[0100] Each slot 117 includes a channel shaped and configured to receive the wire guide 130. The wire guide 130 is configured to receive a wire 140. In various embodiments, the length of the slot 117 is about 25 mm or 25 mm, and the diameter of the channel of the slot 117 is about 6 mm or 6 mm. In various embodiments, the length of the wire guide 130 is about 60 mm or 60 mm, and the diameter of a channel formed in the wire guide 130 is about 2 mm. In various embodiments, the length of the wire guide 130 is in the range of 40 mm to 60 mm, and a wire guide 130 having a proper length may be used depending on body habitus of the patient. In various embodiments, the diameter of the channel formed in the wire guide 130 is variable based on the wire 140 used, and thus, the diameter of the channel in the wire guide 130 may be less than or greater than 2 mm. Therefore, various types of the wire guides 130 with different4937-3900-1173 4065472-000978WOPTdiameters may be available to choose from to accommodate various types / sizes of wires 140.

[0101] In various embodiments, when the wire guide 130 is used to place a drill, the wire guide 130 holding a wire 140 is used to drill the wire 140 into the bone. For example, a fine guide wire 140 is drilled through where the bone tunnel or screw hole is required. Once the guide wire 140 is correctly positioned, the wire guide 130 is removed and a cannulated drill over the wire 140 is used to create a hole in the bone. The diameter of the drill may be variable and needs to be smaller than the diameter of the slot 117 which is 6 mm or about 6 mm.

[0102] In various embodiments, the wire guide 130 received in the slot 117 of the first arm 114 is configured to direct the wire 140 towards the first target point of the calcaneus 150, and the wire guide 130 received in the slot 117 of the second arm 114 is configured to direct the wire 140 towards the second target point of the calcaneus 150. See FIGS. 1 and 2. Thus, when the wires 140 are placed into the first and second target points located at the posterior tuberosity of the calcaneus 150, multi-axial fixation of the posterior tuberosity is achieved, thus allowing improved strength when pulling the calcaneus 150 by manipulating the system 100 or device 110. Unlike uniplanar fixation of the calcaneus 150 in the conventional method which causes pulling out of the bone or deforming the bone fragments, the system 100 or device 110 provides poly-axial fixation that will improve the pulling strength when trying to manipulate a fracture or osteotomy fragment of calcaneus posterior tuberosity. The handle 111 will be much easier to use than a pin with a T handle chuck placed.

[0103] Still referring to FIGS. 3A and 3B, in various embodiments, each receiving portion 116 may also have a threaded hole 118 formed through one of the two parallel horizontal sides into one of the slots 117. For example, the receiving portion 116 of the first arm 114 has two threaded holes 118 formed along axis G, and the receiving portion 116 of the second arm 114 has two threaded holes 118 formed along axis H. The threaded hole 118 formed on the top side of the receiving portion 116 is configured to receive a fastener 119 shown in FIGS. 6-8, and the threaded hole 118 formed on the bottom side of the receiving portion is configured to receive a fastener 119. Each fastener 119 is configured to secure the wire guide 130 inserted into a corresponding slot 117. In some embodiments, the fastener 119 inserted into the threaded hole 118 contacts a portion of the wire guide 130 that is in the slot 117.

[0104] In FIGS. 3A and 3B, axis C is generally perpendicular to axis D, axis C and axis F are generally parallel, axis D and axis E are generally parallel, axis G and axis H are generally parallel, axis E is generally perpendicular to axis G, and axis F is generally perpendicular to axis H.

[0105] Referring to FIG. 4, in various embodiments, the wire guide 130 has a generally4937-3900-1173 4065472-000978WOPTcylindrical shape. In various embodiments, the wire guide 130 includes a stopper portion 131 and an extended portion 132 extending from the stopper portion 131. For example, while the extended portion 132 is insertable into the slot 117, the stopper portion 131 may not be insertable into the slot 117. Further, a channel 133 is formed throughout the length of the wire guide 130. The wire 140 or guide can pass through the channel 133 of the wire guide 130. The wire guide 130 is interchangeable with another wire guide 130 having a different size. For example, the different size of the wire guide 130 is based on a different diameter of the channel 133. Thus, an appropriate wire guide 130 may be selected for use based on the size or diameter of the wire 140 used for the bone manipulation procedure.

[0106] Referring to FIG 5A, the external fixator attachment 120 attachable to the main body 110 has a shape of a curved rod. In various embodiments, the external fixator attachment 120 may include a hexagonal portion 121 configured to be inserted into the through hole 115 having a corresponding hexagonal shape. However, the portion 121 and the corresponding shape of the through hole 115 are not limited to the hexagonal shape. For example, the shape of the portion 121 and the corresponding shape of the through hole 115 may be triangles (3 sides), quadrilaterals (4 sides), pentagons (5 sides) and hexagons (6 sides), heptagons (7 sides), or octagons (8 sides). The external fixator attachment 120 may further include a threaded end portion 122 extending from the hexagonal portion 121. The external fixator attachment 120 is configured to be stably coupled to the main body 110 by a fastener or wing nut 123 (shown in FIG. 5B) releasably couplable to the threaded end portion 122 of the external fixator attachment 120 inserted into the through hole 115.

[0107] As shown in FIG. 6, according to an alternative embodiment, instead of the wing nut 123 shown in FIG. 5B, a different type of fastener 124 may be used to secure the external fixator attachment 120 inserted into the through hole 115 of the main body 110. In this case, the external fixator attachment 120 may have a hexagonal portion 121a without the threaded end portion 122 shown in FIG. 5 A. Further, according to the alternative embodiment, a hole may be formed inside the hexagonal portion 121a, and the fastener 124 having a corresponding protrusion 124a may be inserted into the hole of the hexagonal portion 121a to secure the external fixator attachment 120 to the main body 110. In some embodiments, the hole of the hexagonal portion 121a and the protrusion 124a of the fastener 124 may be threaded.

[0108] FIG. 6 shows various components of the system 100 that can be coupled to the main body 110. For example, the wire guides 130 are detachable from the main body 110. Further, the external fixator attachment 120 is also detachable from the main body 110. In FIG. 6, the fasteners 119 are coupled to the main body 110.4937-3900-1173 4065472-000978WOPT

[0109] FIG. 7 shows that the wire guides 130 are coupled to the receiving portions 116 of the main body 110. The wire guides 130 are secured by the fasteners 119. In various embodiments, each fastener 119 may have a head and a threaded shack that is inserted into the threaded hole 118 of the main body 110. For example, the head of the fastener 119 is shaped to be grabbed by fingers, and the head cannot be inserted into the threaded hole 118.

[0110] Referring to FIG. 8 showing the assembled device or system 100, in various embodiments, the receiving portion 116 of each arm 114 receives two wire guides 130 to receive two wires 140. Further, each receiving portion 116 also receives two fasteners 119, one fastener 119 at the top side of the receiving portion 116 and the other fastener 119 at the bottom side of the receiving portion 116. In FIG. 8, the external fixator attachment 120 is also coupled to the main body 110. Although not shown in FIG. 8, the external fixator attachment 120 is secured to the main body 110 by the fastener 123 coupled to the external fixator attachment 120 underneath the main body 110.

[0111] In various embodiments, the main body 110 and the external fixator attachment 120 are generally made of a radiolucent material. For example, the radiolucent material is carbon fiber. In various embodiments, the main body 110 and the external fixator attachment 120 may be made of plastic in a disposable setting. In some embodiments, the main body 110 and the external fixator attachment 120 may be made of stainless steel in a sterilization setting. In various embodiments, the wire guide 130 is generally made of either plastic or stainless steel.

[0112] Suitable examples of wires and drills that may be utilized with the presently disclosed devices, systems and methods described herein will be apparent to a person of skill in the art. Further, suitable examples of bones that may be manipulated with the presently disclosed devices, systems and methods described herein will be apparent to a person of skill in the art.Methods

[0113] Provided are various embodiments of a method for multi-axial fixation of a bone of a subject to manipulate the bone. In various embodiments, the method includes advancing a first wire 140 through a first wire guide 130 in a first direction along a first axis (axis E shown in FIGS. 3 A and 3B), and the first wire 140 is put into a first target point of the bone 150. The method further includes advancing a second wire 140 through a second wire guide 130 in a second direction along a second axis (axis F shown in FIGS. 3A and 3B) that is generally perpendicular to the first axis (axis E), and the second wire 140 is put into a second target point of the bone 150. The first wire 140 and the second wire 140 put into the bone 150 may be generally perpendicular. See FIGS. 1 and 2.4937-3900-1173 4065472-000978WOPT

[0114] In various embodiments, the bone 150 includes calcaneus or posterior tuberosity.

[0115] In various embodiments, each of the first wire guide 130 and the second wire guide 130 is available in various sizes to accommodate various sizes of wires 140, and the first wire guide 130 or the second wire guide 130 is interchangeable with a different first or second wire guide 130 having a different size. In some embodiments, the different wire guide 130 has a channel having a different diameter.

[0116] In various embodiments, a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the first wire 140 and the second wire 140 put into the bone 150. See FIGS. 1 and 2.

[0117] In various embodiments, the method may further include inserting the first wire guide 130 into a first receiving portion 160 of a bone manipulator 110; and inserting the second wire guide 130 into a second receiving portion 160 of the bone manipulator 110.

[0118] In various embodiments, the method may further include inserting a third wire guide 130 into the first receiving portion 160 of the bone manipulator 110; inserting a fourth wire guide 130 into the second receiving portion 160 of the bone manipulator 110; and advancing a third wire 140 through the third wire guide 130 in the first direction. The third wire 140 is eventually put into a third target point of the bone 150.

[0119] In various embodiments, the method may further include advancing a fourth wire 140 through the fourth wire guide 130 in the second direction. The fourth wire 140 is eventually put into a fourth target point of the bone 150.

[0120] In various embodiments, the first wire guide 130 is inserted into a first slot 117 of the first receiving portion 116, the second wire guide 130 is inserted into a second slot 117 of the second receiving portion 116, the third wire guide 130 is inserted into a third slot 117 of the first receiving portion 116, and the fourth wire guide 130 is inserted into a fourth slot 117 of the second receiving portion 116.

[0121] In various embodiments, the first wire 140 and the third wire 140 put into the bone 150 are generally parallel, and the second wire 140 and the fourth wire 140 put into the bone 150 are generally parallel. See FIGS. 1 and 2.

[0122] In various embodiments, the method further includes inserting a first fastener 119 into a first threaded hole 118 of the first receiving portion 116 to secure the first wire guide 130 in the first slot 117; inserting a second fastener 119 into a second threaded hole 118 of the second receiving portion 116 to secure the second wire guide 130 in the second slot 117; inserting a third fastener 119 into a third threaded hole 118 of the first receiving portion 116 to secure the third wire guide 130 in the third slot 117; and inserting a fourth fastener 119 into a fourth 4937-3900-1173 4 065472-000978WOPTthreaded hole 118 of the second receiving portion 116 to secure the fourth wire guide 130 in the fourth slot 117. See FIGS. 7 and 8.

[0123] In various embodiments, the method further includes positioning the multi-axially fixated bone 150 by manipulating a handle 111 of the bone manipulator 110.

[0124] In various embodiments, the handle I l l is connected to a curved base 113 of the bone manipulator 110 via a bridge 112; a first arm 114 and a second arm 114 diverge from the base 113, the first arm 114 being generally perpendicular to the second arm 114; and the first receiving portion 116 is formed at one end of the first arm 114, and the second receiving portion116 is formed at one end of the second arm 114. See FIGS. 3A and 3B.

[0125] Also provided are various embodiments of a method for manipulating calcaneus of a subject. In various embodiments, the method includes advancing a plurality of first wires 140 through a plurality of first wire guides 130 positioned through a plurality of first slots 117 in a first direction along a first axis (axis E shown in FIGS. 3A and 3B). The plurality of first slots117 are formed at a first receiving portion 116 of a first arm 114 of a calcaneus manipulator 110.

[0126] In various embodiments, the method further includes inserting the plurality of first wires 140 into a plurality of first target points of the bone 150; and advancing a plurality of second wires 140 through a plurality of second wire guides 130 positioned through a plurality of second slots 117 in a second direction along a second axis (axis F shown in FIGS. 3A and 3B) that is generally perpendicular to the first axis (axis E). Also see FIGS. 1 and 2. The plurality of second slots 117 are formed at a second receiving portion 116 of a second arm 114 of the calcaneus manipulator 110.

[0127] In various embodiments, the method may further include inserting the plurality of second wires 140 into a second target point of the bone 150. The plurality of first wires 140 inserted into the bone 150 are generally parallel. The plurality of second wires 140 inserted into the bone 150 are generally parallel. The plurality of first wires 140 and the plurality of second wires 140 inserted into the bone 150 are generally perpendicular. See FIGS. 1 and 2.

[0128] In various embodiments, the method may further include inserting a plurality of first fasteners 119 into a plurality of first threaded holes 118 of the first receiving portion 116 to secure the plurality of first wire guides 130 in the plurality of first slots 117; and inserting a plurality of second fasteners 119 into a plurality of second threaded holes 118 of the second receiving portion 116 to secure the plurality of second wire guides 130 in the plurality of second slots 117.4937-3900-1173 4065472-000978WOPT

[0129] In various embodiments, the method may further include positioning or manipulating the calcaneus 150 multi-axially fixated by the calcaneus manipulator 110 by holding a handle 111 of the calcaneus manipulator 110.

[0130] In various embodiments, the handle 111 is connected to a curved base 113 of the calcaneus manipulator 110 via a bridge 112. In various embodiments, the first arm 114 and the second arm 114 diverging from the base 113 are generally perpendicular. In various embodiments, the first receiving portion 116 is formed at one end of the first arm 114, and the second receiving portion 116 is formed at one end of the second arm 114. See FIGS. 3A and 3B.

[0131] In various embodiments, the subject is a human. In various embodiments, the subject is a mammal. In various embodiments, the devices, systems and methods described herein are configured for humans. The devices, systems, and methods described herein are customizable for use in mammals in which fracture fixation or foot reconstructive procedure is required. “Mammal” as used herein refers to any member of the class Mammalia, including but not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; rodents such as mice, rats, hamsters and guinea pigs; and so on. In certain embodiments, the mammal is a human subject. The term does not denote a particular age or sex. Thus, adult, newborn, fetuses, male or female mammalian heart surgery is within the scope of this disclosure.

[0132] Also in accordance with the present invention, additional steps include, but are not limited to, anesthesia, sterilization, and heparinization.

[0133] The inventive device or system advances the current solutions as follows. The ability of the inventive device or system to provide multi-axial fixation is unique in that no other devices have this. The calcaneus is very soft bone in this area and when screws, Schanz pins, or wires are put into it, they frequently pull through the bone. Having pins coming at a right angle to each other, as achieved by the inventive device, provides significant resistance to pulling out of the bone or loosening.

[0134] Conventional systems use thick Schanz pins to manipulate the heel. These require an incision rather than 1.6 mm poke hole in a tenuous area of skin healing, put a 5 mm hole in the bone and can get in the way of fixation placed to fix the bone. In contrast, the inventive device or system uses multiple smaller wires which have been engineered to aim away from each other4937-3900-1173 4065472-000978WOPTleaving room for fixation. Specifically, by using the inventive device, the wires can be designed to provide a minimum clearance of 5-7 mm between them so that screws placed will not hit the crossing wires.

[0135] The smaller wires used for the inventive device or system can be the size of guide wires that are used in the fixation. Therefore, once the inventive device has been used to manipulate the bone, the wire can be advanced and then a cannulated screw can be placed over the wire.

[0136] Having the handle come between the two sets of wires that are at a right angle to each other, as achieved by the inventive device or system, gives a mechanical advantage to the user trying to move the heel bone. In the conventional systems, a handle is attached to the Schanz pin and is hard to manipulate due to the inherent design and the handle frequently gets in the way of radiographic imaging intra-operatively.

[0137] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and modifications and equivalents thereof.

[0138] In some embodiments, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0139] Preferred embodiments of this application are described herein, including the best mode known to the inventors for carrying out the application. Variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. 4937-3900-1173 4 065472-000978WOPTAccordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.

[0140] It is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.4937-3900-1173 4065472-000978WOPT

Claims

CLAIMS1. A device for manipulating a bone, the device comprising: a main body configured to receive a plurality of wires configured to be inserted into the bone, wherein the device is configured to provide multi-axial fixation of the bone by at least a first wire of the plurality of wires inserted into the bone in a first direction and at least a second wire of the plurality of wires inserted into the bone in a second direction, a first axis along the first direction intersecting with a second axis along the second direction at a point.

2. The device of claim 1, wherein the first axis is generally perpendicular to the second axis.

3. The device of claim 1, wherein the device is configured such that a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the first wire and the second wire inserted into the bone.

4. The device of claim 1, wherein the bone comprises calcaneus.

5. The device of claim 1, wherein the main body comprises a first arm and a second arm diverging from a base of the main body.

6. The device of claim 5, wherein a through hole is formed on the base.

7. The device of claim 6, wherein the through hole is configured to receive an external fixator attachment.

8. The device of claim 7, wherein the external fixator attachment is configured to be connected to an external fixator or a bone distraction device.

9. The device of claim 8, wherein the external fixator attachment is a curved rod.

10. The device of claim 9, wherein the external fixator attachment includes a hexagonal portion configured to be inserted into the through hole having a hexagonal shape.

11. The device of claim 10, wherein the external fixator attachment further includes a threaded end portion extending from the hexagonal portion.

12. The device of claim 11, wherein the external fixator attachment is configured to be stably coupled to the main body by a fastener or wing nut releasably couplable to the threaded end portion of the external fixator attachment inserted into the through hole.

13. The device of claim 5, wherein the base has a curved portion such that the first arm and the second arm that extend from the base in different directions are angled or generally perpendicular.

14. The device of claim 5, wherein the main body further comprises a handle.4937-3900-1173 4065472-000978WOPT15. The device of claim 14, wherein the handle is connected to the base via a bridge located between the handle and the base.

16. The device of claim 15, wherein the bridge extends from a middle portion of the handle towards the base.

17. The device of claim 16, wherein the connected handle and bridge has a generally T shape.

18. The device of claim 17, wherein the connected bridge and base with the first arm and the second arm extending therefrom has a generally Y shape.

19. The device of claim 5, wherein the first arm is generally perpendicular to the second arm.

20. The device of claim 19, wherein a first end of each of the first arm and the second arm is connected to the base.

21. The device of claim 20, wherein each of the first arm and the second arm has a receiving portion formed at a second end of the first or second arm, the receiving portion being configured to receive at least one of the plurality of wires.

22. The device of claim 21, wherein each of the first arm and the second arm is enlarged generally progressively from the first end towards the second end.

23. The device of claim 21 , wherein the receiving portion has a front side having a generally rectangular shape, two parallel vertical sides extending from the front side, and two parallel horizontal sides extending from the front side.

24. The device of claim 23, wherein the front side of the receiving portion of the first arm and the front side of the receiving portion of the second arm are biplanar.

25. The device of claim 21, wherein the receiving portion has at least one slot configured to receive a wire guide, the at least one slot having a channel formed through the two parallel vertical sides.

26. The device of claim 25, wherein a length of the wire guide is about 60 mm.

27. The device of claim 25, wherein a number of the at least one slot in each receiving portion is 1, 2, or 3, each slot being configured to receive a wire guide.

28. The device of claim 25, wherein the at least one slot of the first arm is elongated along the first axis, and the at least one slot of the second arm is elongated along the second axis.

29. The device of claim 25, wherein the at least one slot of the first arm is perpendicular to the at least one slot of the second arm.

30. The device of claim 25, wherein a length of the at least one slot is about 25 mm, and a diameter of a channel formed at the at least one slot is about 6 mm.4937-3900-1173 4065472-000978WOPT31. The device of claim 25, wherein the wire guide is configured to receive and / or guide a wire, the wire being one of the plurality of wires.

32. The device of claim 31, wherein the wire comprises a Kirschner wire or K-wire.

33. The device of claim 31, wherein the wire guide is interchangeable, the interchangeable wire guides being configured to receive various sizes of wires.

34. The device of claim 25, wherein the receiving portion further has at least one threaded hole, the at least one threaded hole being formed through one of the two parallel horizontal sides into one of the at least one slot.

35. The device of claim 34, wherein each of the at least one threaded hole is configured to receive a fastener for holing a wire received by the wire guide.

36. The device of claim 35, wherein the fastener includes a head and a threaded shank that is inserted into the at least one threaded hole, the head being shaped to be grabbed by fingers and not insertable into the at least one threaded hole.

37. The device of claim 34, wherein a number of the at least one slot in each receiving portion is two, and a number of the at least one threaded hole in each receiving portion is two.

38. The device of claim 37, wherein the at least one threaded hole includes a first threaded hole formed into a first slot of the at least one slot and a second threaded hole formed into a second slot of the at least one slot.

39. The device of claim 38, wherein the first threaded hole is configured receive a first fastener configured to secure a first wire guide inserted into the first slot, and the second threaded hole is configured to receive a second fastener configured to secure a second wire guide inserted into the second slot.

40. The device of claim 39, wherein the first wire guide is configured to receive the first wire, and the second wire guide is configured to receive the second wire.

41. A method for multi-axial fixation of a bone of a subject to manipulate the bone, the method comprising: advancing a first wire through a first wire guide in a first direction along a first axis, the first wire being put into a first target point of the bone; and advancing a second wire through a second wire guide in a second direction along a second axis that is generally perpendicular to the first axis, the second wire being put into a second target point of the bone, wherein the first wire and the second wire put into the bone are generally perpendicular.

42. The method of claim 41, wherein the bone includes calcaneus or posterior tuberosity.

43. The method of claim 41 , wherein each of the first wire guide and the second wire guide4937-3900-1173 4065472-000978WOPTis available in various sizes to accommodate various sizes of wires, and the first wire guide or the second wire guide is interchangeable with a different first or second wire guide having a different size.

44. The method of claim 41, wherein a minimum clearance of about 5 millimeters (mm) to about 7 mm is provided between the first wire and the second wire put into the bone.

45. The method of claim 41, further comprising: inserting the first wire guide into a first receiving portion of a bone manipulator; and inserting the second wire guide into a second receiving portion of the bone manipulator.

46. The method of claim 45, further comprising: inserting a third wire guide into the first receiving portion of the bone manipulator; inserting a fourth wire guide into the second receiving portion of the bone manipulator; advancing a third wire through the third wire guide in the first direction, the third wire being put into a third target point of the bone; and advancing a fourth wire through the fourth wire guide in the second direction, the fourth wire being put into a fourth target point of the bone.

47. The method of claim 46, wherein: the first wire guide is inserted into a first slot of the first receiving portion; the second wire guide is inserted into a second slot of the second receiving portion; the third wire guide is inserted into a third slot of the first receiving portion; and the fourth wire guide is inserted into a fourth slot of the second receiving portion.

48. The method of claim 47, wherein the first wire and the third wire put into the bone are generally parallel, and the second wire and the fourth wire put into the bone are generally parallel.

49. The method of claim 47, further comprising: inserting a first fastener into a first threaded hole of the first receiving portion to secure the first wire guide in the first slot; inserting a second fastener into a second threaded hole of the second receiving portion to secure the second wire guide in the second slot; inserting a third fastener into a third threaded hole of the first receiving portion to secure the third wire guide in the third slot; and inserting a fourth fastener into a fourth threaded hole of the second receiving portion to secure the fourth wire guide in the fourth slot.

50. The method of claim 49, further comprising positioning the multi-axially fixated bone4937-3900-1173 4065472-000978WOPTby manipulating a handle of the bone manipulator.

51. The method of claim 50, wherein: the handle is connected to a curved base of the bone manipulator via a bridge; a first arm and a second arm diverge from the base, the first arm being generally perpendicular to the second arm; and the first receiving portion is formed at one end of the first arm, and the second receiving portion is formed at one end of the second arm.

52. A method for manipulating calcaneus of a subject, the method comprising: advancing a plurality of first wires through a plurality of first wire guides positioned through a plurality of first slots in a first direction along a first axis, the plurality of first slots formed at a first receiving portion of a first arm of a calcaneus manipulator; inserting the plurality of first wires into a plurality of first target points of the bone; and advancing a plurality of second wires through a plurality of second wire guides positioned through a plurality of second slots in a second direction along a second axis that is generally perpendicular to the first axis, the plurality of second slots formed at a second receiving portion of a second arm of the calcaneus manipulator; and inserting the plurality of second wires into a second target point of the bone, wherein the plurality of first wires inserted into the bone are generally parallel, wherein the plurality of second wires inserted into the bone are generally parallel, and wherein the plurality of first wires and the plurality of second wires inserted into the bone are generally perpendicular.

53. The method of claim 52, further comprising: inserting a plurality of first fasteners into a plurality of first threaded holes of the first receiving portion to secure the plurality of first wire guides in the plurality of first slots; and inserting a plurality of second fasteners into a plurality of second threaded holes of the second receiving portion to secure the plurality of second wire guides in the plurality of second slots.

54. The method of claim 52, further comprising positioning or manipulating the calcaneus multi-axially fixated by the calcaneus manipulator by holding a handle of the calcaneus manipulator.

55. The method of claim 54, wherein: the handle is connected to a curved base of the calcaneus manipulator via a bridge; the first arm and the second arm diverging from the base are generally perpendicular; and4937-3900-1173 4065472-000978WOPTthe first receiving portion is formed at one end of the first arm, and the second receiving portion is formed at one end of the second arm.

56. The method of claim 52, wherein no bones other than the calcaneus needs to be fixated for multi-axial fixation of the calcaneus and / or manipulation of the calcaneus.

57. The method of claim 52, wherein the method is performed by using minimally invasive osteotomy techniques.

58. The method of claim 52, wherein the method is suitable for minimally invasive calcaneal osteotomies.

59. A system for manipulating a bone, the system comprising: a main body comprising a first arm and a second arm diverging from a base of the main body, the base having a curved or angled portion such that the first arm and the second arm extending from the base are angled, wherein the main body further comprises a handle connected to the base via a bridge located between the handle and the base such that the connected handle and bridge has a generally T shape, and the connected bridge and base with the first arm and the second arm extending therefrom has a generally Y shape; a plurality of wire guides receivable through a plurality of slots formed at a first receiving portion formed at one end of the first arm and at a second receiving portion formed at one end of the second arm; and a plurality of wires configured to pass through the plurality of wire guides and to be inserted into the bone, wherein the system is configured to provide multi-axial fixation of the bone by at least a plurality of first wires of the plurality of wires inserted into the bone in a first direction and at least a plurality of second wires of the plurality of wires inserted into the bone in a second direction, a first axis along the first direction intersecting with a second axis along the second direction at a point.

60. The system of claim 59, wherein the handle is configured to be held by a hand of an operator manipulating the multi-axially fixated bone.

61. The system of claim 59, wherein the bone comprises calcaneus.

62. The system of claim 59, wherein the plurality of wire guides are available in various sizes to accommodate various sizes of wires.

63. The system of claim 62, wherein diameters of the wires are in the range of 0.8 mm -3 mm, including 0.9 mm, 1.1 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.8 mm, 2 mm, 2.2 mm, 2.3 mm, and 2.5 mm, and / or lengths of the wires are in the range of 80 mm -250 mm, including 1004937-3900-1173 4065472-000978WOPTmm, 125 mm, 150 mm, 175 mm, 200 mm, and 225 mm.

64. The system of claim 63, wherein the plurality of wire guides are interchangeable with different wire guides having a different size.

65. The system of claim 64, wherein diameters of channels of the plurality of wire guides are in the range of 0.8 mm - 3 mm, including 2 mm or about 2 mm, and / or lengths of the plurality of wire guides are in the range of 40 mm - 60 mm, including 60 mm or about 60 mm.

66. The system of claim 59, wherein a length of each of the plurality of slots is about 25 mm or 25 mm, and a diameter of a channel of each slot is about 6 mm or 6 mm.

67. The system of claim 59, further comprising an external fixator attachment configured to be connected to an external fixator or a bone distraction device.

68. The system of claim 67, wherein the external fixator attachment is a curved rod and inserted into a through hole formed on the base.

69. The system of claim 68, wherein the external fixator attachment includes a hexagonal portion configured to be inserted into the through hole having a hexagonal shape.

70. The system of claim 69, wherein the external fixator attachment further includes a threaded end portion extending from the hexagonal portion.

71. The system of claim 70, further comprising a fastener or wing nut configured to be releasably coupled to the threaded end portion of the external fixator attachment inserted into the through hole to stably couple the external fixator attachment to the main body.

72. The system of claim 69, wherein a receiving hole is formed at the hexagonal portion of the external fixator attachment.

73. The system of claim 72, further comprising a fastener configured to be inserted into the receiving hold to secure the external fixator attachment to the base.

74. The system of claim 73, wherein both the receiving hole and the fastener are threaded.4937-3900-1173 4065472-000978WOPT

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