Fracture fixation devices and related systems and methods

Abstract

Various embodiments disclosed herein relate to bone fixation devices, including intramedullary fixation or fusion devices. The various devices disclosed include an intermediate device having a proximal member and a distal member connectable to the proximal member. The proximal and distal members have ends that are movably coupled to form a joint that can be actuated to reduce fractures and realign bones after insertion of the device into the bone.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 477,737, entitled "Bone Fracture Fixation Device and Related Systems and Methods," filed December 29, 2022, and U.S. Provisional Application No. 63 / 499,619, entitled "Bone Fracture Fixation Device and Related Systems and Methods," filed May 2, 2023. All of the above applications are incorporated herein by reference in their entireties.

[0002] Various embodiments disclosed herein relate to bone fixation or fusion devices, including intramedullary fixation or fusion devices, that are implanted into a target bone. In addition, other embodiments relate to systems and methods for implanting and adjusting bone fixation or fusion devices. [Background technology]

[0003] Fractures and dislocations, including fibula fractures and syndesmotic dislocations, are common injuries that currently require correction through known fracture / dislocation fixation devices and procedures. Known fracture and / or dislocation fixation devices and systems typically include a central nail and a set screw. Once the nail is implanted within the intramedullary canal of the target bone, there is little or no ability to adjust the nail or reduce the fracture. This lack of adjustability can result in reduced fracture reduction, which can cause reduced or delayed healing and / or ankle malalignment.

[0004] There is a need in the art for improved intramedullary devices and systems for the treatment of fractures and dislocations, including fibula fractures and syndesmotic dislocations. Summary of the Invention

[0005] Discussed herein are various bone fixation or fusion devices and related systems and methods. In Example 1, a bone fixation device includes a device body including a proximal member, a distal member, and a drive mechanism operably coupled to the proximal and distal members. The proximal member includes a proximal lumen defined therein, the proximal lumen being parallel to a longitudinal axis of the proximal member, a drive slot defined therein and in fluid communication with the proximal lumen, the drive slot being transverse to the longitudinal axis of the proximal member, and a distal end having a distal face disposed at an angle in the range of 1 degree to 89 degrees relative to the longitudinal axis of the proximal member. The distal member includes a proximal end having a proximal surface disposed at an angle corresponding to the angle of the distal surface such that the proximal end is in slidable contact with the distal end, the proximal and distal members being radially and axially slidable relative to one another via the distal end of the proximal member and the proximal end of the distal member, and a distal lumen defined in the distal member, the distal lumen being parallel to the longitudinal axis of the distal member and in fluid communication with the proximal lumen. The drive mechanism includes a linear drive shaft slidably disposed within the proximal and distal lumens and a rotatable drive structure rotatably disposed within the distal lumen. The linear drive shaft includes a first engagement structure disposed at a distal end of the linear drive shaft and at least one proximal member engagement structure disposed at the proximal end of the linear drive shaft, the at least one proximal member engagement structure being slidably disposed within a drive slot. The rotatable drive structure includes a second engagement structure disposed at a proximal end of the rotatable drive structure, the second engagement structure being operably coupled with the first engagement structure.

[0006] Example 2 relates to the device of Example 1, further comprising at least one anchoring lumen defined through the distal member, the at least one anchoring lumen transverse to the longitudinal axis of the distal member, and the at least one anchoring lumen in fluid communication with the distal lumen.

[0007] Example 3 relates to the device of Example 2, further comprising at least one transverse lumen defined through the linear drive shaft, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft, and the at least one transverse lumen in fluid communication with the at least one fixed lumen.

[0008] Example 4 relates to the device of Example 1, wherein rotation of a rotatable drive structure within the distal lumen causes the linear drive shaft to move axially within the distal and proximal lumens. Example 5 relates to the device of example 1, wherein the rotatable drive structure is threadably coupled to the inner surface of the distal lumen.

[0009] Example 6 relates to the device of Example 1, wherein the linear drive shaft comprises a proximal section having a proximal section diameter and a distal section having a distal section diameter, the distal section diameter being larger than the proximal section diameter.

[0010] Example 7 relates to the device of example 1, wherein at least one fixation lumen comprises a thread defined in an inner wall of the at least one fixation lumen. In Example 8, a bone fixation device includes a device body including a proximal member and a distal member, an adjustable joint formed between the proximal member and the distal member, and a drive mechanism operably coupled to the proximal member and the distal member. The proximal member includes a shaft lumen defined therein that is parallel to a longitudinal axis of the proximal member and a drive slot defined therein that is transverse to the longitudinal axis of the proximal member. The distal member includes a drive mechanism lumen defined therein that is parallel to the longitudinal axis of the distal member, and at least one fixation lumen defined therein that is transverse to the longitudinal axis of the distal member and in fluid communication with the drive mechanism lumen. With respect to the adjustable joint, the proximal member and the distal member are radially and axially movable relative to each other via the adjustable joint. The drive mechanism comprises a rotatable drive structure rotatably disposed within the drive mechanism lumen, the rotatable drive structure comprising a rotatable engagement structure disposed at a proximal end of the rotatable drive structure, and a linear drive shaft slidably disposed within the drive mechanism lumen, the linear drive shaft comprising a stationary engagement structure disposed at a distal end of the linear drive shaft configured to mate with the rotatable engagement structure, at least one transverse lumen defined therethrough, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft and in fluid communication with the at least one stationary lumen, and at least one protrusion disposed at a proximal end of the linear drive shaft, the at least one protrusion slidably disposed within the drive slot.

[0011] Example 9 relates to the device of example 8, wherein rotation of the rotatable drive structure within the drive mechanism lumen causes the linear drive shaft to move axially within the drive mechanism lumen. Example 10 relates to the device of example 8, wherein the rotatable drive structure is threadably coupled to an inner surface of the drive mechanism lumen.

[0012] Example 11 relates to a device described in Example 8, wherein the at least one fixation lumen comprises a first and a second fixation lumen, and the first fixation lumen has a longitudinal axis that intersects the longitudinal axis of the second fixation lumen.

[0013] Example 12 relates to the device of Example 11, wherein the at least one transverse lumen comprises a first and a second transverse lumen, the first transverse lumen having a longitudinal axis that intersects the longitudinal axis of the second transverse lumen.

[0014] Example 13 relates to the device of Example 8, wherein the linear drive shaft comprises a proximal section having a proximal section diameter and a distal section having a distal section diameter, the distal section diameter being larger than the proximal section diameter.

[0015] Example 14 relates to the device of example 13, wherein at least one transverse lumen is defined in the distal section. Example 15 relates to the device described in Example 8, further comprising a removable cap, the removable cap being removably connectable to a distal opening defined in the distal member, the distal opening being in fluid communication with the drive mechanism lumen.

[0016] Example 16 relates to the device of example 8, wherein the at least one fixation lumen comprises a thread defined in an inner wall of the at least one fixation lumen. In Example 17, a bone fixation device includes a device body including a proximal member and a distal member, a slidable joint formed between the proximal member and the distal member, where the distal member is movable radially and axially relative to the proximal member via the slidable joint, and a drive mechanism operably coupled to the proximal member and the distal member, the proximal member including a proximal lumen defined therein, the proximal lumen being parallel to a longitudinal axis of the proximal member, and a drive slot defined therein and in fluid communication with the proximal lumen, the drive slot being transverse to the longitudinal axis of the proximal member. The distal member comprises a distal lumen defined therein, the distal lumen parallel to the longitudinal axis of the distal member and in fluid communication with the proximal lumen, and at least one fixed lumen defined therein, the fixed lumen transverse to the longitudinal axis of the distal member and in fluid communication with the distal lumen. The drive mechanism comprises a rotatable drive structure rotatably disposed within the distal lumen, the rotatable drive structure comprising a first engagement structure disposed at a proximal end of the rotatable drive structure, and a linear drive shaft slidably disposed within the proximal and distal lumens. The linear drive shaft includes a second engagement structure disposed at a distal end of the linear drive shaft, the second engagement structure operably coupled to the first engagement structure; at least one transverse lumen defined through the linear drive shaft, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft and in fluid communication with the at least one fixed lumen; and at least one radial protrusion disposed at a proximal end of the linear drive shaft, the at least one radial protrusion slidably disposed within the drive slot.

[0017] Example 18 relates to the device of example 17, wherein the first engagement structure comprises a substantially rounded protrusion extending proximally from the rotatable drive structure. Example 19 relates to the device of Example 18, wherein the second engagement structure comprises an engagement slot sized and shaped to receive the first engagement structure such that the first engagement structure is rotatable relative to the linear drive shaft but not axially movable relative to the linear drive shaft.

[0018] Example 20 relates to a device described in Example 17, wherein the distal member is movable radially and axially relative to the proximal member via a slidable joint between an aligned position in which the longitudinal axis of the distal member is substantially coaxial with the longitudinal axis of the proximal member and an engaged position in which the longitudinal axis of the distal member is non-coaxial with and parallel to the longitudinal axis of the proximal member.

[0019] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. As will be realized, the present disclosure can be modified in various obvious aspects without departing from the spirit and scope of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0020] [Figure 1A] FIG. 1 is a schematic diagram of a tibia and fractured fibula. [Figure 1B] FIG. 1 is a schematic diagram of a displaced fibula fracture. [Figure 2] FIG. 10 is a side view of a fixation device according to one implementation. [Figure 3] 3 is a further side view of the fixation device of FIG. 2 in a coupled position, according to one implementation. [Figure 4] FIG. 10 is a bottom perspective view of a fixturing device and drive mechanism with certain components removed for visibility, according to one implementation. [Figure 5A] 1 depicts an exemplary rack and worm drive mechanism for incorporation into any of the embodiments herein, according to one embodiment. [Figure 5B]10 depicts another exemplary rack and pinion drive mechanism for incorporation into any of the embodiments herein, according to a further embodiment. [Figure 6A] FIG. 10 is a side view of a fixation device according to another implementation. [Figure 6B] FIG. 6B is a side view of an exemplary opening of the fixation device of FIG. 6A, according to one implementation. [Figure 7A] FIG. 1 illustrates a lateral view of a patient's fibula with an implanted fixation device, according to one implementation. [Figure 7B] FIG. 7B is a posterior view of the fibula (and foot) of the patient of FIG. 7A with an implanted fixation device, according to one implementation. [Figure 7C] FIG. 7B is a bottom perspective view of the patient's foot and fibula of FIG. 7A with an implanted fixation device, according to one implementation. [Figure 8A] FIG. 10 is an enlarged side view of a portion of a fixation device according to another embodiment. [Figure 8B] FIG. 8B is a further enlarged side view of a portion of the fixation device of FIG. 8A in a coupled position, according to one embodiment. [Figure 9A] FIG. 10 is an enlarged side view of a portion of another fixation device according to a further embodiment. [Figure 9B] FIG. 9B is a further enlarged side view of a portion of the fixation device of FIG. 9A in a coupled position, according to one embodiment. [Figure 10A] FIG. 10 is a side view of an overall fixation device in an aligned position, according to one implementation. [Figure 10B] FIG. 10B is an enlarged side view of a portion of the fixation device of FIG. 10A, according to one embodiment. [Figure 11A] 10 is an enlarged side view of a portion of another fixation device in an aligned position according to a further embodiment. FIG. [Figure 11B] FIG. 11B is another enlarged side view of the portion of the fixation device of FIG. 11A in an aligned position, according to one embodiment. [Figure 11C] FIG. 11B is an enlarged side view of a portion of the fixation device of FIG. 11A in a coupled position, according to one embodiment. [Figure 11D]FIG. 11B is another enlarged side view of the portion of the fixation device of FIG. 11A in a coupled position, according to one embodiment. [Figure 11E] FIG. 11B is yet another enlarged side view of more of the fixation device of FIG. 11A in an aligned position, according to one embodiment. [Figure 11F] FIG. 11B is another enlarged side view of the portion of the fixation device of FIG. 11A in an aligned position, according to one embodiment. [Figure 11G] FIG. 11B is a further enlarged side view of the drive mechanism of the fixturing device of FIG. 11A, according to one embodiment. [Figure 12A] FIG. 10 is an enlarged side view of a portion of another fixation device in a coupled position, depicting an internal drive mechanism, according to a further embodiment. [Figure 12B] FIG. 12B is another enlarged side view of the portion of the fixation device of FIG. 12A in a coupled position, according to one embodiment. [Figure 12C] FIG. 12B is another enlarged side view of the portion of the fixation device of FIG. 12A in an aligned position, according to one embodiment. [Figure 13A] 13 is a side view of the entire fixation device in an aligned position depicting the internal drive mechanism according to a further embodiment; FIG. [Figure 13B] FIG. 13B is another side view of the entire fixation device of FIG. 13A in an aligned position, according to one embodiment. [Figure 13C] FIG. 13B is yet another side view of the entire fixation device of FIG. 13A in an aligned position, according to one embodiment. [Figure 13D] FIG. 13B is an additional side view of the entire fixation device of FIG. 13A in an aligned position, according to one embodiment. [Figure 14] FIG. 1 illustrates a perspective view of a positioning device, according to one embodiment. [Figure 15A] FIG. 1 is a side view of a fractured bone having a displaced fracture and a fixation device positioned within the fractured bone, according to one embodiment. [Figure 15B] FIG. 15B is a side view of the fractured bone of FIG. 15A with the fixation device actuated to its interlocking position to reduce the fracture and realign the bone, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0021] Various embodiments disclosed and contemplated herein relate to adjustable intramedullary fixation and / or fusion devices and related systems and methods. Each of the devices is configured to allow adjustment of the device after implantation in the target bone. While the devices disclosed and contemplated herein are taught with reference to the fibula, they may be implemented in a variety of other bones, as will be understood by those skilled in the art, including, for example, the ulna and other similar bones. Certain implementations may be used not only to correct fibula fractures and syndesmotic dislocations, but also to correct similar fractures of other similar bones, such as the ulna.

[0022] 1A and 1B, in one exemplary fracture that can be treated by various embodiments herein, the fibula 2 is fractured or dislocated and may require surgical intervention to reduce and stabilize the injury. The fibula fracture 4 (or any target fracture) can be non-displaced (as shown in FIG. 1A) or displaced (as shown in FIG. 1B). A displaced fracture 4 must be reduced and realigned to allow for proper healing. Known fixation devices allow little or no ability to adjust the placement of the fixation device and / or reduce the fracture 4 after insertion of the fixation device. In contrast, various fixation device implementations disclosed and / or contemplated herein have adjustable joints to allow for adjustment of the fixation device after insertion.

[0023] As depicted in FIGS. 2-4 and 6A-7C, bone fixation device (also referred to herein as a "nail" or "rod") 10, according to one implementation, is an elongated device that is placed within the medullary canal of fibula 2 or other target bone for fixation of the bone following injury. Device 10 has a device body 11 having a proximal elongated section 12 and a distal elongated section 14. The two portions 12, 14 of body 11 are adjustably coupled to one another at a joint 16. FIG. 2 depicts device body 11 in an aligned position (also referred to herein as the "insertion position"), while FIG. 3 shows device body 11 in a coupled position, and FIG. 4 shows an enlarged view of joint 16 (also referred to as the "adjustment mechanism")

[0024] The two sections 12, 14 of the body 11 are identified as the proximal section 12 and the distal section 14 based on the positioning of the body 11 within the target bone and, therefore, the resulting positions of each of the sections 12, 14. That is, upon insertion into the target bone (as discussed in detail below with respect to Figures 7A and 7B), the proximal section 12 is positioned toward the proximal end of the bone, while the distal section 12 is positioned toward the distal end of the bone.

[0025] As shown in FIGS. 7A and 7B , the proximal portion (also referred to as the “first shaft,” “proximal member,” “proximal shaft,” “proximal pin,” or “first rod”) 12 of the device body 11 is an elongated structure having a blunt tip 13 at its proximal end to facilitate insertion into the medullary canal. As best shown in FIGS. 2-4 , the distal end of the proximal shaft 12 forms a junction 16 with the proximal end of the distal shaft 14. The distal portion (also referred to as the “second shaft,” “distal member,” “distal shaft,” “distal pin,” or “second rod”) 14 is coupled at its proximal end to the proximal portion 12 via the junction 16. The junction 16 is arranged so that the proximal portion 12 and the distal portion 14 can move relative to each other through the junction 16 in the direction of reference arrow A, which is substantially transverse to the longitudinal axis of the device body 11. That is, a drive mechanism 20 is provided that can actuate the two shafts 12, 14 to move substantially radially relative to one another at the junction 16.

[0026] In the specific embodiment depicted herein, interface 16 is configured as follows: The distal end of proximal shaft 12 has a matable feature or feature 18 disposed thereon that is matably and movably coupled with a driven gear (also referred to herein as a "cam drive" or "worm") 22 on the proximal end of distal shaft 14, as shown. In one exemplary implementation as shown, matable feature 18 is a plurality of grooves 18 that can matably mate with threads or teeth on driven gear 22, such that rotation of gear 22 causes movement of matable feature 18 (and thus proximal shaft 12). Alternatively, matable feature 18 can be any known structure, feature, or mechanism that can matably mate with a driven gear, including teeth, threads, etc., in a similar manner. Additionally, driven gear 22 can be any known type of gear and therefore can have any type of mateable structure that can mate with mateable mechanism or structure 18 such that rotation of gear 22 can cause movement of mechanism 18.

[0027] As best shown in FIG. 4 , according to one specific implementation, the mateable feature or structure 18 is disposed on or formed on a protrusion 19 disposed on the distal end of the proximal shaft 12. Alternatively, the feature 18 can be disposed on or formed directly on the distal end of the proximal shaft 12. Additionally, in certain embodiments, including the device depicted in FIG. 4 , the driven gear 22 is disposed a distal distance from the proximal end of the distal shaft 14. That is, the proximal end of the distal shaft 14 has a channel 21 defined therein such that the threads or teeth of the gear 22 are disposed within the channel 21. In such an implementation, the protrusion 19 of the proximal shaft is disposed within the channel 21 such that the mateable feature or structure 18 on the protrusion 19 mates with the teeth or threads of the gear 22. According to one particular embodiment, the protrusion 19 has a coupling mechanism that slidably mates with and couples with a coupling mechanism associated with the channel 21, thereby ensuring that the two shafts 12, 14 remain coupled together while the drive mechanism 20 moves the two shafts 12, 14 relative to one another as described herein.

[0028] The drive mechanism 20 disposed on the distal shaft 14 is comprised of a drive shaft 26 and a rotatable driven gear 22, with the shaft 26 rotatably coupled to the gear 22 at a matable feature or structure 28 disposed at or near the proximal end of the shaft 26. In one embodiment, the matable feature or structure 28 is a set of screw threads 28. Alternatively, any known matable feature or structure capable of mating with the gear 22 can be used. Thus, the gear 22 is operably coupled to both the matable feature or structure 18 of the proximal portion 12 and the matable feature or structure 28 of the drive shaft 26 such that rotation of the drive shaft 26 causes rotation of the matable feature or structure 28, thereby actuating the gear 22 to rotate on a different axis compared to the axis of the drive shaft 26. Actuation of driven gear 22 rotates gear 22, thereby matably coupling with matable feature or structure 18 of proximal portion 12 and urging matable feature or structure 18, and thus distal shaft 14, to move angularly relative to proximal shaft 12 in the direction of reference arrow A. That is, according to certain implementations, actuation of drive mechanism 20 moves distal shaft 14 relative to proximal shaft 12 because proximal shaft 12 is securely positioned within the proximal portion of the medullary canal of the target bone such that proximal shaft 12 cannot move relative to the target bone. That is, in certain target bones (e.g., the fibula), the medullary canal in the proximal portion of the bone is narrower than the canal in the distal portion. Thus, when device 10 is positioned within the medullary canal of the target bone, proximal shaft 12 is positioned within the narrower portion of the medullary canal such that shaft 12 cannot move radially (or can move radially only a small distance) relative to the target bone. Alternatively, either or both of the proximal shaft 12 or the distal shaft 14 can move relative to the other.

[0029] As best shown in FIG. 3 , according to certain implementations, regardless of the drive mechanism incorporated into the device 10, the distal end 13 of the proximal shaft 12 and the proximal end 15 of the distal shaft 14 are angled. That is, the two ends 13, 15 of the two shafts 12, 14 are each disposed at an angle as shown to cause angular movement when the drive mechanism 20 is actuated to move the two shafts 12, 14 relative to one another. More specifically, the distal end 13 of the proximal shaft 12 is disposed at an angle that is not perpendicular to the longitudinal axis of the shaft 12. Similarly, the proximal end 15 of the distal shaft 14 is parallel to the distal end 13 of the proximal shaft 12 and disposed at an angle that is mateable with the angle of the distal end 13 of the proximal shaft 12, such that the two ends 13, 15 can be mateably coupled or positioned in movably contact with one another, as shown. Furthermore, the threads 18 are disposed at an angle that is the same as or parallel to the angle of the two ends 13, 15. It will be understood that the angular arrangement of the two ends 13, 15 as shown allows for both radial and axial movement of the two shafts 12, 14 relative to one another. This angular movement can provide fracture alignment, both radially and axially, to align two misaligned lengths of bone, as desired. Furthermore, in this device 10 and any of the various embodiments herein, the ends 13, 15 can have angles different from those depicted in FIG. 3 . That is, the joint angle (the matching angle of the two ends 13, 15) can be varied to obtain the optimal amount of axial versus radial movement. If it is desired to have equal axial and radial movement, the angle can be set at 45°. Alternatively, if it is desired to have more axial movement than radial movement, the angle can be set to achieve that. Similarly, if it is desired to have more radial movement than axial movement, the angle can be set to achieve that. It is understood that any angle between 0° and 90° can be used in any of the various device implementations disclosed or contemplated herein. Alternatively, the angle can range from about 20° to about 70°. In a further alternative, the angle can range from about 30° to about 60°.In yet another alternative, the angle may range from about 0° to about 30°.

[0030] Additionally, the drive shaft 26 may extend to the distal end of the distal shaft 14 and have a connection component 30 at its distal end accessible through an opening 31 at the distal end of the distal shaft 14 so that a driver tool can be coupled to the connection component 30. The connection component 30 may be an opening, a protrusion, or any mateable connection mechanism 30 that allows a driver tool to be coupled thereto. For example, the mateable connection mechanism 30 in this specific embodiment is an opening 30 defined at its distal end whereby a mechanical actuation component (also referred to herein as a “driver component,” “hex driver,” or “driver”) (not shown) may be inserted into the opening 30 to rotate the drive shaft 26. More specifically, the opening 30 has a hexagonal shape (or any known mateable and operable shape) that is mateable with the distal end of a driver (not shown) so that the driver can be used to rotate the shaft 26 through the hexagonal-shaped opening 30. Alternatively, the distal end of drive shaft 26 can have any known coupling mechanism or connection component that can be matably coupled with an appropriate corresponding driver tool. The drive tool can be used by a user (e.g., a surgeon) to actuate drive mechanism 20 to adjust joint 16. More specifically, rotation of connection mechanism 30 (via the tool) causes rotation of drive shaft 26, which in turn causes rotation of gear 22, thereby adjusting the position of proximal shaft 12 relative to distal shaft 14.

[0031] It will be understood that any other known drivers and similar mechanisms for use in medical devices can be used in place of the drive mechanism 20 as shown in Figures 2-4. For example, as depicted in Figures 5A and 5B, various other drive mechanisms 20 can be used in conjunction with the device 10. In one example, a rack and worm mechanism 20 as shown in Figure 5A can be implemented. In another example, a rack and pinion or gear drive 20 as shown in Figure 5B can be implemented.

[0032] 6A-6B, in certain implementations, the device 10 may also include one or more apertures 32, 34 for insertion of a set screw, syndesmosis screw, or other similar known fixation device. Various screws or other types of known mechanisms may be placed through the apertures 32, 34 in the device 10 to secure the device 10 relative to the target bone of the patient and reduce instability. For example, the proximal aperture 32 is located in the proximal shaft 12 to allow angular placement of a syndesmosis screw or other screw into the tibia across the syndesmosis. The distal aperture 34 is provided for fixation of the distal shaft 14 of the device 10 within the bone.

[0033] In some implementations, each of the openings 32, 34 is arranged in the shape of a frustum of a cone, as best shown in the exemplary depiction of one such opening 32, 34 in Figure 6B. In these implementations, the inner portion of opening 32A is wider than the transverse portion of opening 32B. It will be understood that various other configurations and shapes are possible.

[0034] In some implementations, device 10 can be made of one or more metals. For example, device 10 can be made of titanium, stainless steel, or other suitable metallic material or combination of metallic materials, as would be understood by one of ordinary skill in the art. Alternatively, device 10 can be made of any known material for use in bone fixation and / or other medical devices.

[0035] It will be appreciated that the device 10 may be of various sizes and shapes as needed for the target bone, medullary canal, fracture, and particular anatomy of the patient. Various lengths and widths of the device 10 may be used.

[0036] In use, as depicted in FIGS. 7A-7C , a fixation device 10 according to any embodiment disclosed or contemplated herein can be placed into the medullary canal of a fibula 2 or other target bone via any suitable surgical technique. For example, the other target bone can include, but is not limited to, a humerus, tibia, femur, or any other long bone. In some implementations, the distal portion 14 has a bend (also referred to as an “angle” or “curve”) 40, as best shown in FIG. 7B , intended to substantially replicate the bend or curve of the target fibula 2, thereby ensuring intramedullary placement. In various implementations, the bend 40 is approximately 7° of bend. Alternatively, any known angle that improves placement of the device 10 can be used, depending on the target bone and any curvature thereof. Of course, other shapes are possible.

[0037] In one example, device 10 is inserted by drilling a pilot hole in the distal end of the patient's fibula 2. A guidewire may then be inserted through the pilot hole into the medullary canal and a hole may be drilled over the guidewire. Device 10 may be inserted into a hole in the medullary canal of fibula 2. Of course, various other techniques and methods may be used, as will be understood by those skilled in the art.

[0038] An external targeting device (not shown) may be used to assist in accurate and reproducible placement of the device 10 and / or screws. The external targeting device may be placed external to the fracture 4. It is understood that a variety of targeting devices are known in the art.

[0039] In various implementations, the device 10 should be positioned within the fibula 2 or other target bone so that the joint 16 is substantially adjacent to the fracture 4. After the device 10 is positioned within the fibula or other target bone, the drive mechanism 20 can actuate the joint 16 to move the two shafts 12, 14 relative to one another, thereby reducing the fracture 4 and engaging to realign the bone. The ability to actuate the proximal portion 12 relative to the distal portion 14 (and / or vice versa) after insertion allows a surgeon or other user to correct and adjust bone alignment and fracture reduction after implantation of the device 10. The device 10 is positioned within the bone and actuated to hold the bone in proper alignment during the healing process. Improved fracture reduction and proper bone alignment can lead to faster healing and better outcomes for the patient.

[0040] Another embodiment of a fixation device 50 is depicted in FIGS. 8A and 8B, which provide close-up views of the drive mechanism 70 and joint 58 of the device 50. Except as expressly discussed herein, the various components and features of this embodiment of the device 50 are substantially similar to or identical to the components and features of the various embodiments disclosed or contemplated above and depicted in FIGS. 2-7C. In this implementation, the device 50 has a device body 52 with a proximal elongated section 54 and a distal elongated section 56 that are adjustably coupled to one another at a joint 58 such that a drive mechanism 70 can move the two sections 54, 56 substantially radially relative to one another. FIG. 8A depicts the device body 52 in an aligned (or "inserted") position or configuration, while FIG. 8B shows the device body 52 in a coupled position or configuration.

[0041] It should be noted that in all of the various embodiments herein, the "aligned" or "inserted" configuration describes the device body (in this specific case, body 52), not the state of the target bone. That is, when device 50 (or any device implementation herein) is inserted into the target bone, device body 52 is aligned, but the target bone is not aligned (fractured). Similarly, when a device body (such as body 52) is biased into its coupled configuration (e.g., such as the configuration depicted in FIG. 8B ), that is when the target bone is intended to be corrected, and thus, biased into alignment (to treat the fracture).

[0042] Furthermore, it should be noted that in most implementations, when the device is inserted into the target bone, the proximal section (such as section 54) of the various device embodiments herein is positioned within the bone such that proximal section 54 is substantially unable to move. Thus, relative movement of the proximal and distal shafts (such as proximal shaft 54 ​​and distal shaft 56 in this embodiment) as discussed with respect to the various implementations herein generally involves movement of the distal shaft relative to the proximal shaft.

[0043] In this exemplary embodiment, the junction 58 is configured as follows. As best shown in FIG. 8B , the distal end of the proximal shaft 54 ​​has a matable feature or feature 60 disposed thereon that is matably and movably coupled to a matable feature 62 disposed on the proximal end of the distal shaft 56, as shown. More specifically, in this exemplary implementation, the matable feature 60 is two elongated protrusions (or “ribs”) 60A, 60B, and the matable feature 62 is two corresponding channels 62A, 62B. In this manner, the two ribs 60A, 60B are slidably positioned within and can matably couple with the two channels 62A, 62B such that the two protrusions 60A, 60B can slide within the two channels 62A, 62B. Alternatively, the matable mechanisms 60, 62 may be any known structure, feature, or mechanism that can be matably and slidably coupled to allow movement of the two shafts 64, 66 relative to one another via the matable mechanisms 60, 62.

[0044] The drive mechanism 70 disposed on the distal shaft 56 (and operatively coupled to the proximal shaft 54) is comprised of a rotatable drive screw 72 rotatably coupled to a linear driven shaft 74. More specifically, the drive screw 72 has external threads 76 defined thereon and is rotatably disposed within a lumen 78 defined in the driven shaft 74. The lumen 78 has matching threads (not shown) defined on an inner surface thereof. In this manner, rotation of the drive screw 72 within the lumen 78 causes linear or axial translation of the driven shaft 74. The driven shaft 74 has at its proximal end a slidable block 80 slidably disposed within a radial slot 82 defined in the proximal shaft 54 ​​such that the block 80 can slide within the slot 82. Additionally, the drive screw 72 has a mateable connection component 84 defined or otherwise disposed at the distal end of the drive screw 72. The mateable connection component 84 may be any known mateable structure or mechanism 84 for receiving or coupling with a driving tool (not shown) so that the tool can be used to rotate the screw 72.

[0045] In the distal shaft 56, the drive screw 72 and driven shaft 74 are movably disposed within a first axial lumen (or "drive mechanism lumen") 86 defined in the distal shaft 56. Additionally, as best shown in FIG. 8A , a retention structure (or "retainer" or "protrusion") 88 is positioned adjacent to and coupled with the drive screw 72 such that the protrusion 88 is disposed within a channel 90 defined in the screw 72. In this manner, the protrusion 88 allows the screw 72 to rotate but prevents the screw 72 from moving axially.

[0046] The distal shaft 56 also has a second axial lumen (or “drive tool lumen”) 92 that extends from the distal end of the shaft 56 to the first lumen 86. Additionally, the distal shaft 56 has an opening 94 at its distal end that is in fluid communication with the lumen 92. Thus, when a user or surgeon wishes to use the drive screw 72 to adjust the positioning of the distal shaft 56 and the proximal shaft 54 ​​relative to one another, a drive tool (such as a wrench or any other known tool) can be inserted into the lumen 92 and coupled to the drive screw 72 at the connection component 84.

[0047] In certain implementations, the distal portion of the drive tool lumen 92 can have threads 96 defined on the inner surface of the lumen 92. The threads 96 can be used to mate with a cap or plug (not shown) that can be inserted into the lumen 92 and mateably coupled to the threads 96 to provide a closure or covering for the lumen 92. Alternatively, any mateable feature or structure 96 can be incorporated therein. Such a cap or other covering structure can be used with any of the device embodiments disclosed or contemplated herein. According to some embodiments, the cap or other covering structure is used to cover the opening 94 and lumen 92 to prevent bone ingrowth therein. The cap or other structure can be attached to the distal end of the distal shaft 56 either before or after the device 50 is implanted and can be removed when a user or surgeon desires access to the lumen 92 to actuate the drive mechanism 70.

[0048] In a further alternative, the threads 96 of this embodiment (and any other implementations herein) can also be used to remove the device 50. That is, when it is desired to withdraw or otherwise remove the device 50 from the target bone, the cap as discussed above can be removed (if previously attached), and a removal tool (not shown) having external threads on its exterior surface can be inserted into the lumen 92 and threadably coupled to the threads 96 within the lumen 92. Once the removal tool is attached to the distal shaft 56 via the threads, the tool can then be used to remove the device 50 from the bone.

[0049] When used according to various implementations, the device 50 is positioned within the fibula or other target bone so that the joint 58 is substantially adjacent the fracture. After the device 50 is positioned within the fibula or other target bone, the drive mechanism 70 can actuate the joint 58 to move the two shafts 54, 56 relative to one another, thereby reducing the fracture and engaging to realign the bone. More specifically, a drive tool (not shown) is inserted into the drive tool lumen 92 and coupled to the drive screw 72 at the connection component 84. Once the drive tool is coupled to the drive screw 72, the tool can be used to rotate the drive screw 72, thereby axially moving the driven shaft 74 in one direction or the other, which in turn radially moves the proximal shaft 54 ​​in one direction or the other relative to the distal shaft 56. For example, the device 50 can be initially positioned in an insertion configuration, as shown in FIG. 8A . The drive tool can then be used to rotate the drive screw 72, causing the driven shaft 74 to axially move in the proximal direction. This moves lock 80 proximally, as shown in FIG. 8B, urging distal shaft 56 to move distally and radially along joint 58 via slidable ribs 60A, 60B, as discussed above. Also, block 80 moves only radially relative to proximal shaft 54, such that as distal shaft 56 moves radially ("left" as shown in FIG. 8B) and axially ("down" as shown in FIG. 8B), the position of block 80 changes within slot 82, as shown. Alternatively, in certain embodiments, proximal shaft 54 ​​can move relative to distal shaft 56, or both shafts 54, 56 can move relative to each other.

[0050] A further implementation of fixation device 100 is depicted in FIGS. 9A and 9B, which provide an expanded view of drive mechanism 120 and joint 108 of device 100. Except as expressly discussed herein, the various components and features of this embodiment of device 100 are substantially similar or identical to the components and features of the various embodiments disclosed or contemplated above and depicted in FIGS. 2-7C. In this implementation, device 100 has a device body 102 with a proximal elongated section 104 and a distal elongated section 106 that are adjustably coupled to one another at joint 108 such that drive mechanism 120 can move the two sections 104, 106 substantially radially relative to one another. FIG. 9A depicts device body 102 in an aligned position, and FIG. 9B shows device body 102 in a coupled position.

[0051] In this exemplary embodiment, the joint 108 is configured as follows. As best shown in FIG. 9B , the distal end of the proximal shaft 104 has a matable feature or feature 110 disposed thereon that is matably and movably coupled to a matable feature 112 disposed on the proximal end of the distal shaft 106, as shown. More specifically, in this exemplary implementation, the matable feature 110 is two elongated protrusions (or “ribs”) 110A, 110B, and the matable feature 112 is two corresponding channels 112A, 112B. In this manner, the two ribs 110A, 110B are slidably positioned within and can matably couple to the two channels 112A, 112B such that the two protrusions 110A, 110B can slide within the two channels 112A, 112B. Alternatively, the matable features 110, 112 may be any known structure, feature, or mechanism that can be matably and slidably coupled to allow movement of the two shafts 104, 106 relative to one another via the matable features 110, 112.

[0052] The drive mechanism 120 disposed on or otherwise associated with the distal shaft 106 (and operably coupled to the proximal shaft 104) is comprised of a rotatable drive screw 122 operably coupled to a linear driven shaft 124. More specifically, the drive screw 122 has external threads 126 defined thereon and is rotatably disposed within a drive mechanism lumen 128 defined in the distal shaft 106. The lumen 128 has matching threads 130 defined on an interior surface thereof. In this manner, rotation of the drive screw 122 within the lumen 128 causes linear or axial movement of the drive screw 122 and, therefore, axial movement of the driven shaft 124. More specifically, the drive screw 122 has a channel 132 defined therein, and the driven shaft 124 has a protrusion 134 extending into and positioned within the channel 132. In this manner, rotation of the drive screw 122 causes axial movement of the screw 122 within the lumen 128 (as a result of the threads 126, 130), which causes axial movement of the protrusion 134, which causes axial movement of the driven shaft 124.

[0053] The driven shaft 124 is slidably disposed along the side of the distal shaft 106. Alternatively, the driven shaft 124 can be slidably disposed within an elongated lumen defined within the distal shaft 106. At or near its proximal end, the driven shaft 124 has a rotatable link 136 rotatably coupled to the driven shaft 124 at a rotatable joint 138. The rotatable link 136 is coupled at a first end to the rotatable joint 138 and at a second end to the proximal shaft 104 at a slot 140 defined in the proximal shaft 104, as shown. More specifically, the link 136 has at its second end a protrusion or rod 142 slidably disposed within the slot 140. In this manner, axial movement of the driven shaft 124 causes some axial movement of the rotatable link 136 to be transmitted to the proximal shaft 104 by the link 136. 9A and 9B, and as described in more detail elsewhere herein. Additionally, as shaft 104 moves radially, link protrusion 142 slides within slot 140.

[0054] The distal shaft 106 has an opening 144 at its distal end that is in fluid communication with the lumen 128. Thus, when a user or surgeon desires to use the drive screw 122 to adjust the positioning of the distal shaft 106 and the proximal shaft 104 relative to one another, a driving tool (such as a wrench or any other known tool) can be inserted into the lumen 128 and coupled to the drive screw 122 at a connecting component (not shown).

[0055] In certain implementations, the threads 130 of the lumen 128 can also be used to mate with a cap or plug (not shown) that can be inserted into the lumen 128 and mateably coupled to the threads 130 to provide a closure or covering for the lumen 128 when adjustment of the drive mechanism 120 is not required. Alternatively, any mateable feature or structure 130 can be incorporated therein. In a further alternative, the threads 130 of this embodiment (and any other implementations herein) can also be used for removal of the device 100. That is, when it is desired to withdraw or otherwise remove the device 100 from the target bone, a removal tool (not shown) having external threads on its exterior surface can be inserted into the lumen 128 and threadably coupled to the threads 130 in the lumen 128. Once the removal tool is attached to the distal shaft 106 via the threads, the tool can be used to remove the device 100 from the bone.

[0056] When used according to various implementations, the device 100 is placed within the fibula or other target bone such that the joint 108 is substantially adjacent to the fracture. After the device 100 is placed within the fibula or other target bone, the drive mechanism 120 can actuate the joint 108 to move the two shafts 104, 106 relative to one another, thereby reducing the fracture and engaging to realign the bone. More specifically, a drive tool (not shown) is inserted into the drive tool lumen 128 and coupled to the drive screw 122 at a connecting component (not shown). Once the drive tool is coupled to the drive screw 122, the tool can be used to rotate the drive screw 122, thereby axially moving the drive screw 122 in one direction or the other, which in turn axially moves the prongs 134 in one direction or the other relative to the distal shaft 106. This causes the driven shaft 124 to move axially in one direction or the other relative to the distal shaft 106, which in turn moves the rotatable link 136 axially, which in turn moves the proximal shaft 104 axially and radially along the joint 108 as described elsewhere herein. For example, the device 100 can first be placed in an insertion configuration, as shown in FIG. 9A . A driving tool can then be used to rotate the drive screw 122 so that the driven shaft 124 moves axially in the distal direction. This moves the second end of the rotatable link 136 radially, as shown in FIG. 9B , urging the proximal shaft 104 to move proximally and radially along the joint 108 via the slidable ribs 110A, 110B, as discussed above. Also, as the protrusion 142 moves radially (to the “right,” as shown in FIG. 9B ), the proximal shaft 104 similarly moves radially (and axially) “to the right.”

[0057] 10A and 10B depict another embodiment of a fixation device 150. More specifically, FIG. 10A depicts a view of the entire device 150, while FIG. 10B shows an enlarged view of the distal portion of the distal shaft 156 and proximal shaft 154 of the device 150. Except as expressly discussed herein, the various components and features of this embodiment of the device 150 are substantially similar to or identical to the components and features of the various embodiments disclosed or contemplated above and depicted in FIGS. 2-9B. In this implementation, the device 150 has a device body 152 with a proximal elongated section 154 and a distal elongated section 156 adjustably coupled to one another at a joint 158 ​​such that a drive mechanism (not shown) can move the two sections 154, 156 substantially radially relative to one another. The drive mechanism in this device 150 can be any of the implementations of the drive mechanisms disclosed or contemplated above.

[0058] In this embodiment, proximal shaft 154 has a proximal portion (or length) 154A and a distal portion 154B, with distal portion 154B having a larger diameter than proximal portion 154A. According to one embodiment, distal portion 154B has a diameter ranging from about 0.5 mm to about 15 mm, while proximal portion 154A has a diameter ranging from about 2 mm to about 4 mm. Furthermore, distal portion 154B has three lumens 160A, 160B, and 160C defined therein, each of which is configured to receive a fixation screw 162A, 162B, and 162C, as shown, or other similar mechanism. The larger diameter of distal portion 154B allows for the inclusion of three lumens 160A, 160B, and 160C, thereby providing greater stability and fixation compared to known devices without such a distal portion and three such openings.

[0059] Each of the three openings 160A-C has an axis that is substantially transverse to the longitudinal axis of the proximal shaft 154 (and distal portion 154B). In one embodiment shown, the axes of all three lumens 160A-C are substantially parallel to one another. Alternatively, the axes of the three openings 160A-C are not parallel to one another. Furthermore, in certain embodiments, the lumens 160A-C do not have threads defined within their interior surfaces. In such implementations, the threadable screws 162A-C (or other similar mechanisms) shown are not attached to the proximal shaft 154 via threads or any other mechanism, but instead are simply positioned through the lumens 160A-C, and the screws 162A-C are attached to bone disposed on either side of the shaft 154. Alternatively, the lumens 160A-C have threads defined therein.

[0060] In certain embodiments, the distal shaft can also have lumens 164A, 164B defined therethrough, each of which is configured to receive a locking screw 166A, 166B as shown or other similar mechanism. Each of the lumens 164A, 164B has an axis that is substantially transverse to the longitudinal axis of the distal shaft 146. In one embodiment shown, the axes of the two lumens 164A, 164B are not parallel to one another. That is, the two lumens 164A, 164B are defined through the distal shaft 146 at different angles relative to one another. Alternatively, the axes of the two lumens 164A, 164B can be substantially parallel to one another. Additionally, in certain embodiments, lumens 164A, 164B have threads defined within the interior surface of lumens 164A, 164B such that screws 166A, 166B can matably couple to distal shaft 146 via threads on the exterior surface of screws 166A, 166B and threads defined within the interior surface of lumens 164A, 164B. Alternatively, lumens 164A, 164B do not have threads defined therein.

[0061] Another embodiment of a fixation device 200 is depicted in Figures 11A-12C, which depict close-up views of a drive mechanism 220 and joint 208 of the device 200. Except as expressly discussed herein, the various components and features of this embodiment of the device 200 are substantially similar or identical to the components and features of the various embodiments disclosed or contemplated above and depicted in Figures 2-10B. In this implementation, the device 200 has a device body 202 with a proximal elongated section 204 and a distal elongated section 206 that are adjustably coupled to one another at joint 208 such that a drive mechanism 220 can move the two sections 204, 206 substantially radially relative to one another. 11A and 11B (together with FIGS. 11E and 11F) depict the device body 202 in an aligned (or "inserted") position or configuration, while FIGS. 11C and 11D show the device body 202 in a coupled position or configuration.

[0062] In this exemplary embodiment, the joint 208 is configured as follows: As best shown in Figures 11C, 11D, 12B, and 12C, the distal end of the proximal shaft 204 has a matable feature or feature 210 disposed thereon that is matably and movably coupled to a matable feature 212 disposed on the proximal end of the distal shaft 206, as shown. More specifically, as best shown in Figure 12B, in this exemplary implementation, the matable feature 210 on the proximal shaft 204 is two elongated outer protrusions (or "ribs") 210A, 210B that define an inner channel 210C disposed therebetween. Furthermore, as best shown in Figures 12B and 12C, the matable feature 212 is an elongated protrusion 212 that is matable with and slidable within the inner channel 210C, as shown. Additionally, the elongated projection 212 has two wings 212A, 212B (as best shown in FIG. 12C ) extending therefrom such that the wings 212A, 212B slidably fit within two transverse channels 211A, 211B defined within the inner channel 210C (as best shown in FIG. 12B ). In this manner, the two wings 212A, 212B help to retain the projection 212 within the channels 210C. Alternatively, the matable features 210, 212 may be any known structure, feature, or mechanism capable of matably and slidably coupling to permit movement of the two shafts 204, 206 relative to one another via the matable features 210, 212.

[0063] 11A and 11C, drive mechanism 220 disposed on distal shaft 206 (and operatively coupled to proximal shaft 204) is comprised of a rotatable drive screw 222 rotatably coupled to a linear driven shaft 224. More specifically, as best shown in FIGS. 11A-11B, drive screw 222 has external threads 226 defined thereon and is rotatably disposed within a lumen 228 defined in distal shaft 206. Additionally, drive screw 222 has a protrusion 223 rotatably disposed within a slot 225 defined in driven shaft 224 (as best shown in FIG. 11G) such that drive screw 222 can freely rotate relative to driven shaft 224. Lumen 228, as shown, has matching threads 230 (also shown in FIG. 11G) defined on an interior surface near the distal end of lumen 228.

[0064] 11A-11D, the driven shaft 224 has slidable rods 230A, 230B at its proximal end that are slidably disposed within radial slots 232 defined in the proximal shaft 204 such that the rods 230A, 230B can slide within the slots 232. Additionally, as best shown in FIG. 11C, the drive screw 222 has a matable connection component 234 defined or otherwise disposed at the distal end of the drive screw 222. The matable connection component 234 can be any known matable structure or mechanism 234 for receiving or coupling with a driving tool (not shown), such that the tool can be used to rotate the screw 222.

[0065] 11A, 11C, 11E, and 11F, the distal end of the distal shaft 206 can also have a removable cap 227 removably attached thereto. More specifically, in certain embodiments, the cap 227 can have external threads 229 (as shown in FIGS. 11A and 11C) that can be inserted through the distal opening 221 into the distal end of the lumen 228 (as shown in FIGS. 11B and 11D) and threadably coupled to the internal threads 230 of the lumen 228. Additionally, the cap 227 can have a matable structure or mechanism 231 that can be coupled to a tool for attaching or removing the cap 227 from the distal shaft 206. Once the cap 227 is removed, the matable connection component 234 of the drive screw 222 can be accessed by a tool (not shown) for rotating the screw 222 and thus actuating the drive mechanism 220, as described below.

[0066] In a further alternative, the internal threads 230 of the lumen 228 in this embodiment (and any other implementation herein) can also be used to remove the device 200. That is, when it is desired to withdraw or otherwise remove the device 200 from the target bone, the cap 227, as discussed above, can be removed (if a cap was previously attached), and a removal tool (not shown) having external threads on its exterior surface can be inserted into the lumen 228 and threadably coupled to the threads 230 in the lumen 228. Once the removal tool is attached to the distal shaft 206 via the threads, the tool can be used to remove the device 200 from the bone.

[0067] 11A-11D, driven shaft 224 has a distal section 224A and a proximal section 224B extending from distal section 224A. In one implementation as shown, distal section 224A is slidably disposed within lumen 228 such that distal section 224A can move axially within lumen 228. Additionally, proximal section 224B has a smaller diameter than distal section 224A and extends from distal shaft 206 across junction 208 to proximal shaft 204, as shown.

[0068] 11E, 11F, and 12A, the drive shaft 224 can have two slots 240, 242 defined therethrough. Each of the slots 240, 242 is defined in the shaft 224 such that it communicates with a corresponding lumen 244, 246 defined in the distal shaft 206, as best shown in FIGS. 12A and 12B. More specifically, the distal shaft 206 can have two lumens 244, 246 configured to receive fixation screws (or other known attachment mechanisms) 248, 250, as best shown in FIGS. 12A-12C. Slots 240, 242 are defined in shaft 224 such that slots 240, 242 allow set screws 248, 250 to be disposed through distal shaft 206 and axially slidable drive shaft 224, while allowing drive shaft 224 to move freely axially as needed for operation of drive mechanism 220, as discussed above. More specifically, lumen 244 is in communication with slot 240 such that screw 248 can be positioned through lumen 244 and slot 240 regardless of the axial position of drive shaft 224 within distal shaft 206. Similarly, lumen 246 is in communication with slot 242 such that screw 250 can be positioned through lumen 244 and slot 242 regardless of the axial position of drive shaft 224 within distal shaft 206. Thus, the drive mechanism 220 can be used to urge the device 200 between an insertion position and an engagement position while the screws 248, 250 are inserted through the distal shaft 206 (and the bone in which the device 200 is positioned), as discussed elsewhere herein.

[0069] According to some embodiments, the two lumens 244, 246 are defined through the distal shaft 206 (and corresponding slots 240, 242 in the drive shaft 224) at different angles relative to one another. In certain specific implementations, the axes of the two lumens 244, 246 (and corresponding slots 240, 242) are substantially transverse to one another. Furthermore, in certain embodiments, the lumens 244, 246 have threads defined within their interior surfaces such that the screws 248, 250 can be matably coupled to the distal shaft 206 via threads on the exterior surfaces of the screws 248, 250 and threads defined within the interior surfaces of the lumens 244, 246. Alternatively, the lumens 244, 246 do not have threads defined therein.

[0070] As shown in Figures 12A-12C, proximal shaft 204 according to one embodiment has proximal portion (or length) 204A and distal portion 204B, with distal portion 204B having a larger diameter than proximal portion 204A. According to one embodiment, distal portion 204B has a diameter ranging from about 0.5 mm to about 15 mm, while proximal portion 204A has a diameter ranging from about 2 mm to about 4 mm. Furthermore, distal portion 204B has three lumens 260A, 260B, 260C defined therein, each of which is configured to receive a fixation screw 262A, 262B, 262C, as shown, or other similar mechanism. The larger diameter of distal portion 204B allows for the inclusion of three lumens 260A, 260B, 260C, thereby providing greater stability and fixation compared to known devices without such a distal portion and three such openings.

[0071] Each of the three openings 260A-C has an axis that is substantially transverse to the longitudinal axis of the proximal shaft 204 (and distal portion 204B). In one embodiment shown, the axes of the three openings 260A-C are not parallel to one another. More specifically, as shown in FIGS. 12A-12C, each of the three openings 260A-C has an axis that is not parallel to any two of the openings 260A-C. According to one exemplary embodiment, each axis is offset by approximately 5 degrees relative to the axes of the other two openings. Thus, opening 260B has an axis that is offset by approximately 5 degrees relative to opening 260A, and opening 260C has an axis that is offset by approximately 5 degrees relative to opening 260B. In one specific exemplary implementation, the planes of each opening 260A-C are oriented at 15, 20, and 25 degrees from the anterior / posterior faces, respectively.

[0072] In one embodiment, the center of opening 260A is located approximately 59 mm from the distal end of device 200, while the center of opening 260B is located approximately 49.5 mm from the distal end of device 200, and the center of opening 260C is located approximately 40 mm from the distal end of device 200. Alternatively, the location of each opening 260A-C can vary from approximately 1 mm to approximately 5 mm in either direction relative to the exemplary locations listed above.

[0073] Additionally, in certain embodiments, lumens 260A-C do not have threads defined within their interior surfaces. In such implementations, threadable screws 262A-C (or other similar mechanisms) are not attached to proximal shaft 204 via threads or other mechanisms as shown, but instead are simply placed through lumens 260A-C and attached to bone where screws 262A-C are located on either side of shaft 204. Alternatively, lumens 260A-C have threads defined therein.

[0074] When used according to various implementations, device 200 is positioned within a fractured fibula or other target bone such that joint 208 is substantially adjacent the fracture. For example, in one exemplary embodiment as shown in FIG. 15A , device 200 (or any other device embodiment disclosed or contemplated herein, such as devices 10, 50, 100, or 300) can be inserted into fractured target bone 350. Furthermore, if desired, device 200 can be rotated while positioning it within bone 350 to ensure that the angle of joint 208 is substantially parallel to the angle of fracture 352, as represented by line A in FIG. 15A . If desired, once device 200 is positioned, at least one fixation screw (or other attachment device) (e.g., screw 262C) can be inserted through bone portion 350A above fracture 352 and through a lumen (e.g., lumen 260C) in proximal shaft 204. Additionally, at least one fixation screw (or other attachment device) (such as screw 248) can be inserted through the bone portion 350B below the fracture 352 and through a lumen (such as lumen 244) within the distal shaft 206.

[0075] 15B , once each shaft 204, 206 of device 200 is attached to one of two fracture sections 350A, 350B of bone 350, respectively, a drive mechanism (such as mechanism 220 as discussed in detail above) can actuate distal shaft 206 to move relative to proximal shaft 204 along joint 208 such that distal shaft 206 moves in the direction indicated via arrow B, which is substantially parallel to fracture 352 of bone 350. Additionally, because distal shaft 206 is attached to bone section 350B via at least one fixation screw (such as screw 248), distal shaft 206 thereby biases bone section 350B to move along fracture 352 in the same direction as indicated by arrow B relative to bone section 350A. The drive mechanism can be actuated to bias the distal shaft 206 as shown until bone section 350B is biased back into realignment with bone section 350A (or "realigned" or "coupled"), thereby reducing the fracture 352. Alternatively, actuation of the drive mechanism can move both shafts 204, 206 relative to one another, thereby reducing the fracture 352 and realigning the bone 350. In a further alternative, actuation of the drive mechanism can move the proximal shaft 204 relative to the distal shaft 206, thereby realigning the bone 350.

[0076] According to one specific embodiment, the exemplary drive mechanism 220 as discussed above can be operated to achieve bone realignment and fracture reduction in the following manner. A drive tool (not shown) is inserted into the distal opening 221 of the distal shaft 206, into the lumen 228, and coupled to the drive screw 222 at the connection component 234. Once the drive tool is coupled to the drive screw 222, the tool can be used to rotate the drive screw 222, thereby axially moving the driven shaft 220 in one direction or the other, which in turn radially moves the distal shaft 206 in one direction or the other relative to the proximal shaft 204. For example, the device 200 can first be placed in the insertion configuration, as shown in FIGS. 11A, 11B, 12C, and 15A. The drive tool can then be used to rotate the drive screw 222, causing the driven shaft 220 to axially move in the proximal direction. 11C, 11D, 12A, 12B, and 15B, urging the distal shaft 206 to move distally and radially along the joint 208 via the slidable projection 212, as discussed above. Also, as the distal shaft 206 moves radially (to the "right" as shown in FIG. 11B and to the "left" as shown in FIG. 15B), the rods 230A, 230B move only axially, such that the position of the rods 230A, 230B changes within the slot 232, as shown. Alternatively, any drive mechanism according to any of the implementations disclosed or contemplated herein can be used to achieve fracture reduction and bone realignment as discussed herein.

[0077] 10A-10B and 12A-12C, an implementation of device 300 is depicted in FIGS. 13A-13D, in which another device 300 has a different outer diameter compared to previous embodiments. Except as expressly discussed herein, the various components and features of this device 300 embodiment are substantially similar or identical to the components and features of the various embodiments disclosed or contemplated above and depicted in FIGS. 2-12C. In this implementation, device 300 has a device body 302 with a proximal elongated section 304 and a distal elongated section 306, which are adjustably coupled to one another at a junction 308 such that a drive mechanism 310 can move the two sections 304, 306 substantially radially (and in some cases, axially as well) relative to one another. However, unlike the previous embodiments discussed above, device 300 has three different diameters along its length. More specifically, proximal shaft 304 has proximal portion (or length) 304A, intermediate portion (or length) 304B, distal portion (or length) 304C, as well as proximal transition portion (or length) 304D between proximal portion 304A and intermediate portion 304B, and distal transition portion (or length) 304E between intermediate portion 304B and distal portion 304C, wherein distal portion 304C has a larger diameter than intermediate portion 304B, which has a larger diameter than proximal portion 304A. Further, distal shaft 306 has the same diameter as distal portion 304B of proximal shaft 304. In addition, device 300 also has a tip 312 at the proximal end of proximal shaft 304, which has a diameter that narrows along the length of tip 312 from the distal end of tip 312 to the proximal end of tip 312, as shown.

[0078] According to one exemplary embodiment, distal shaft 306 and distal portion 304C of proximal shaft 304 have a diameter of 7 mm, while intermediate portion 304B of proximal shaft 304 has a diameter of about 6 mm and proximal portion 304A has a diameter of about 3 mm. Alternatively, distal shaft 306 and distal portion 304C of proximal shaft 304 can have a diameter ranging from about 1 mm to about 6 mm, intermediate portion 304B can have a diameter ranging from about 3 mm to about 12 mm, and proximal portion 304A can have a diameter ranging from about 4 mm to about 12 mm.

[0079] In some implementations, the proximal tip 312 has a length of approximately 7 mm, the proximal portion 304A of the proximal shaft 304 has a length of approximately 49 mm, the proximal transition portion 304D has a length of approximately 8.5 mm, the intermediate portion 304B and the distal transition portion 304E have a combined length of approximately 26.5 mm, and the distal portion 304C and the distal shaft 306 have a combined length of approximately 34 mm. Alternatively, proximal tip 312 can have a length in the range of about 1 mm to about 20 mm, proximal portion 304A can have a length in the range of about 10 mm to about 500 mm, proximal transition portion 304D can have a length in the range of about 5 mm to about 30 mm, intermediate portion 304B and distal transition portion 304E can have a combined length in the range of about 10 mm to about 500 mm, and distal portion 304C and distal shaft 306 can have a combined length in the range of about 10 mm to about 500 mm.

[0080] Additionally, intermediate portion 304B of proximal shaft 304 has three lumens 314A, 314B, 314C defined therein, each of which is configured to receive a fixation screw (not shown) or other similar mechanism. Lumens 314A-C can be substantially similar to lumens 160A-C and / or lumens 260A-C in the embodiments discussed above, including their dimensions and characteristics.

[0081] 14 depicts one example of a positioning device 320 that can be used to position any of the embodiments of bone fixation devices disclosed or contemplated herein. More specifically, a positioning device 320 according to certain embodiments can assist in both the insertion and positioning of the bone fixation device and can also function as a drill guide for the correct positioning of fixation screws. For example, as shown in the figure, the positioning device 320 is used to position an exemplary bone fixation device 322 while also providing a drill guide 330 for positioning fixation screws that secure the device 322 in place within the target bone. The positioning device 320 has a device body 324 with a fixation device mounting structure 326 at the proximal end of the device 320 and at least two openings (such as opening 328) through which a drill guide 330 can be positioned at the distal end of the device 320, and is provided with a depth gauge 332 thereon for determining the appropriate fixation screw length. In use, the bone fixation device 322 is attached to the mounting structure 326 as shown, and then the bone fixation device 322 is urged against a target bone (not shown) using the positioning device 320. Optionally, once the fixation device 322 is positioned within the target bone, a drill guide (such as guide 330 as shown) can be inserted into an appropriate one of the drill guide openings 328 to ensure that the drill and fixation screws are properly positioned and that the fixation screws are positioned through the fixation screw lumens (as described elsewhere herein) in the bone fixation device 322. Optionally, once the fixation screws have been inserted, the positioning device 320 can be removed.

[0082] Although the various systems described above are separate implementations, any of the individual components, mechanisms, or devices, and associated features and functionality within the various system embodiments described in detail above may be incorporated into any of the other system embodiments herein.

[0083] As used herein, the terms "about" and "substantially" refer to variations (including numerical quantities or structures) that may occur through typical measurement techniques and equipment with respect to any quantifiable variable, including, but not limited to, mass, volume, time, distance, wavelength, frequency, voltage, current, and electromagnetic fields. Furthermore, in the real world, there are certain incidental errors and variations that are likely due to differences in the manufacture, source, or precision of components used to make various components or perform methods, etc. The terms "about" and "substantially" encompass these variations as well. The terms "about" and "substantially" can include variations of either 5% or 10%, or any amount between 0% and 10% (including any integer). Furthermore, whether modified by the terms "about" or "substantially," the claims include the equivalent of the amount or quantity.

[0084] Numerical ranges recited herein are inclusive of the numbers defining the range and include each integer within the defined range. Throughout this disclosure, various aspects of the disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges, fractions, and individual numerical values ​​within that range. For example, the description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6, and decimals and fractions, e.g., 1.2, 3.8, 1 1 / 2, and 4 3 / 4. This applies regardless of the breadth of the range. While various embodiments have been described with reference to preferred implementations, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope thereof.

[0085] Although various embodiments have been described with reference to preferred implementations, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.

Claims

1. 1. A bone fixation device comprising: (a) a device body, (i) a proximal member, (A) a proximal lumen defined within the proximal member, the proximal lumen being parallel to a longitudinal axis of the proximal member; (B) a drive slot defined in the proximal member and in fluid communication with the proximal lumen, the drive slot transverse to the longitudinal axis of the proximal member; (C) a distal end having a distal surface disposed at an angle in the range of 1 degree to 89 degrees relative to the longitudinal axis of the proximal member; a proximal member comprising: (ii) a distal member, (A) a proximal end having a proximal surface disposed at an angle corresponding to the angle of the distal surface such that the proximal end is in slidable contact with the distal end, and the proximal member and the distal member are radially and axially slidable relative to one another via the distal end of the proximal member and the proximal end of the distal member; (B) a distal lumen defined within the distal member, the distal lumen being parallel to a longitudinal axis of the distal member and in fluid communication with the proximal lumen; a distal member comprising: a device body comprising: (b) a drive mechanism operably coupled to the proximal member and the distal member, (i) a linear drive shaft slidably disposed within the proximal and distal lumens, (A) a first engagement structure disposed at a distal end of the linear drive shaft; (B) at least one proximal member engagement structure disposed on a proximal end of the linear drive shaft, the at least one proximal member engagement structure being slidably disposed within the drive slot; a linear drive shaft comprising: (ii) a rotatable drive structure rotatably disposed within the distal lumen, the rotatable drive structure including a second engagement structure disposed at a proximal end of the rotatable drive structure, the second engagement structure operably coupled to the first engagement structure; and a drive mechanism comprising: A bone fixation device comprising:

2. 10. The device of claim 1, further comprising at least one anchoring lumen defined through the distal member, the at least one anchoring lumen transverse to the longitudinal axis of the distal member and in fluid communication with the distal lumen.

3. 3. The device of claim 2, further comprising at least one transverse lumen defined through the linear drive shaft, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft and in fluid communication with the at least one fixed lumen.

4. The device of claim 1 , wherein rotation of the rotatable drive structure within the distal lumen causes the linear drive shaft to move axially within the distal and proximal lumens.

5. The device of claim 1 , wherein the rotatable drive structure is threadably coupled to an inner surface of the distal lumen.

6. The device of claim 1 , wherein the linear drive shaft comprises a proximal section including a proximal section diameter and a distal section including a distal section diameter, the distal section diameter being larger than the proximal section diameter.

7. The device of claim 1 , wherein the at least one fixation lumen comprises a thread defined in an inner wall of the at least one fixation lumen.

8. 1. A bone fixation device comprising: (a) a device body, (i) a proximal member, (A) a shaft lumen defined within the proximal member, the shaft lumen being parallel to a longitudinal axis of the proximal member; (B) a drive slot defined in the proximal member, the drive slot transverse to the longitudinal axis of the proximal member; a proximal member comprising: (ii) a distal member, (A) a drive mechanism lumen defined within the distal member, the drive mechanism lumen being parallel to a longitudinal axis of the distal member; (B) at least one anchoring lumen defined within the distal member, the at least one anchoring lumen transverse to the longitudinal axis of the distal member and in fluid communication with the drive mechanism lumen; a distal member comprising: a device body comprising: (b) an adjustable joint formed between the proximal member and the distal member, wherein the proximal member and the distal member are movable radially and axially relative to one another via the adjustable joint; and (c) a drive mechanism operably coupled to the proximal member and the distal member, (i) a rotatable drive structure rotatably disposed within the drive mechanism lumen, the rotatable drive structure comprising a rotatable engagement structure disposed at a proximal end of the rotatable drive structure; (ii) a linear drive shaft slidably disposed within the drive mechanism; (A) a stationary engagement structure disposed at a distal end of the linear drive shaft, the stationary engagement structure configured to mate with the rotatable engagement structure; (B) at least one transverse lumen defined through the linear drive shaft, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft and in fluid communication with the at least one fixed lumen; (C) at least one protrusion disposed on a proximal end of the linear drive shaft, the at least one protrusion being slidably disposed within the drive slot; a linear drive shaft comprising: a drive mechanism comprising: A bone fixation device comprising:

9. The device of claim 8 , wherein rotation of the rotatable drive structure within the drive mechanism lumen causes the linear drive shaft to move axially within the drive mechanism lumen.

10. The device of claim 8 , wherein the rotatable drive structure is threadably coupled to an inner surface of the drive mechanism lumen.

11. 9. The device of claim 8, wherein the at least one fixation lumen comprises first and second fixation lumens, the first fixation lumen having a longitudinal axis that transverses a longitudinal axis of the second fixation lumen.

12. 12. The device of claim 11, wherein the at least one transverse lumen comprises first and second transverse lumens, the first transverse lumen having a longitudinal axis that transverses a longitudinal axis of the second transverse lumen.

13. The device of claim 8 , wherein the linear drive shaft comprises a proximal section including a proximal section diameter and a distal section including a distal section diameter, the distal section diameter being larger than the proximal section diameter.

14. The device of claim 13 , wherein the at least one transverse lumen is defined in the distal section.

15. 10. The device of claim 8, further comprising a removable cap, the removable cap removably coupleable to a distal opening defined in the distal member, the distal opening in fluid communication with the drive mechanism lumen.

16. The device of claim 8 , wherein the at least one fixation lumen comprises a thread defined in an inner wall of the at least one fixation lumen.

17. 1. A bone fixation device comprising: (a) a device body, (i) a proximal member, (A) a proximal lumen defined within the proximal member, the proximal lumen being parallel to a longitudinal axis of the proximal member; (B) a drive slot defined in the proximal member and in fluid communication with the proximal lumen, the drive slot transverse to the longitudinal axis of the proximal member; a proximal member comprising: (ii) a distal member, (A) a distal lumen defined within the distal member, the distal lumen being parallel to a longitudinal axis of the distal member and in fluid communication with the proximal lumen; (B) at least one fixation lumen defined within the distal member, the at least one fixation lumen transverse to the longitudinal axis of the distal member and in fluid communication with the distal lumen; a distal member comprising: a device body comprising: (b) a slidable joint formed between the proximal member and the distal member, the distal member being movable radially and axially relative to the proximal member through the slidable joint; (c) a drive mechanism operably coupled to the proximal member and the distal member, (i) a rotatable drive structure rotatably disposed within the distal lumen, the rotatable drive structure including a first engagement structure disposed at a proximal end of the rotatable drive structure; (ii) a linear drive shaft slidably disposed within the proximal and distal lumens; (A) a second engagement structure disposed at a distal end of the linear drive shaft, the second engagement structure being operably coupled to the first engagement structure; (B) at least one transverse lumen defined through the linear drive shaft, the at least one transverse lumen transverse to a longitudinal axis of the linear drive shaft and in fluid communication with the at least one fixed lumen; (C) at least one radial protrusion disposed on a proximal end of the linear drive shaft, the at least one radial protrusion being slidably disposed within the drive slot; a linear drive shaft comprising: a drive mechanism comprising: A bone fixation device comprising:

18. The device of claim 17 , wherein the first engagement structure comprises a substantially rounded protrusion extending proximally from the rotatable drive structure.

19. 20. The device of claim 18, wherein the second engagement structure comprises an engagement slot sized and shaped to receive the first engagement structure such that the first engagement structure is rotatable relative to the linear drive shaft but not axially movable relative to the linear drive shaft.

20. 18. The device of claim 17, wherein the distal member is movable radially and axially relative to the proximal member via the slidable joint between an aligned position in which the longitudinal axis of the distal member is substantially coaxial with the longitudinal axis of the proximal member and a coupled position in which the longitudinal axis of the distal member is non-coaxial with and parallel to the longitudinal axis of the proximal member.

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