Separable bone fixation device and related methods

Abstract

Embodiments of various bone fixation devices include both a fixation device (such as a screw) and a separable driver device. The fixation device has an elongated non-cannulated fixation shaft, a sharp distal tip, and a proximal head having a first coupling structure and a proximal flat surface. The separable driver device has an elongated driver shaft and a distal head having a second coupling structure and a distal flat surface. Further implementations include a combination device that includes both the separable driver device and the fixation device, as well as related systems and methods. Additionally, a stabilization device is provided that is coupled to the separable driver device and the attachment device to maintain the connection between the driver device and the attachment device and to help maintain their connection during the procedure.

Description

Technical Field

[0001] Various embodiments of the present specification relate to bone fixation devices and procedures for fracture stabilization and / or repair, arthrodesis, plate stabilization, and bone reconstruction, etc.

Background Art

[0002] For performing various forms of bone surgery, including fracture repair and arthrodesis, various temporary bone fixation devices and permanent bone fixation devices are often used in combination. The two most common temporary fixation devices are Kirschner wires ("K-wires") and olive wires, while the most common permanent fixation device is a screw.

[0003] A K-wire is a smooth or threaded metal headless pin with a thin wire design and a sharp distal tip, which can be inserted into bone by true percutaneous placement (enabling the surgeon to directly push the pointed tip from the skin into the bone) without using any pre-drilling or pre-measuring steps, and then driven into the bone with a known electric drive device. Therefore, the K-wire can be quickly inserted in one step. Usually, K-wires are used to temporarily maintain fracture reduction or bone alignment before placing screws, plates, or other permanent fixation devices. In some cases, the K-wire can also be left in place at a predetermined position as the final fixation implant by bending the K-wire or cutting the wire shorter than its original length. In other cases, the proximal end of the K-wire can be protruded from the bone under the skin or through the skin and removed later.

[0004] One drawback of K-wires is that when the K-wire is fully inserted into the bone, there is no head that engages the outer surface of the target bone, such as a conventional screw head, at the proximal end (or along the length) of the wire. Therefore, since the K-wire lacks a head, it cannot provide any compression between the two bone fragments.

[0005] The olive wire is a generally temporary fixation wire having an extended pin / wire shaft (smooth or threaded) with a pointed tip at one end, and is similar to the K-wire in that it enables direct penetration of bone without using pre-drilling. However, in contrast to the K-wire, the olive wire has a head-like spherical structure (which may resemble the shape of an olive and is thus named) that functions like a screw head along the length of the wire. Thus, as the wire is inserted and advanced into the bone, the spherical structure engages the outer surface of the bone and provides compression (a distinct advantage over the K-wire). In addition to bone compression, the spherical structure also allows the olive wire to be used for holding a temporary fixation plate (prior to the placement of permanent screws). The olive wire is typically removed once the screws are inserted, and depending on the plate design and fixation construct, the remaining olive holes may be filled with additional screws. Regardless of the intended use of the olive wire, the length of the wire proximal to the spherical structure (driver end) is often quite long (in some examples, up to 10 cm) to facilitate subsequent removal.

[0006] One drawback of the olive wire is that, because the driver end protrudes from the spherical structure, it may interfere with or obstruct the surgical procedure. Trimming the wire can reduce the interference, but there is a risk that the tip of the wire may become exposed and sharp, presenting an additional risk.

[0007] Fixing screws are typically used in combination with either K-wire or olive wire to fix the bone. As discussed above, K-wire or olive wire is typically first placed to temporarily hold the bone in place. Since both types of wires create small holes, they can be removed and reinserted until the surgeon is satisfied and ready for permanent fixation (using screws, plates, external fixators, or other forms of bone fixators). In contrast, the insertion of bone fixing screws requires multiple steps including drilling, countersinking, tapping, and finally screw insertion. Additionally, cannulated screws require at least one additional step of first placing the guide wire before positioning the cannulated screw on the guide wire (and in some cases, additional steps of capturing an image of the guide wire and measuring its depth). Thus, one drawback of bone screws is the large number of steps required to achieve permanent fixation.

[0008] In the art, there is a need for improved fixation devices. SUMMARY OF THE INVENTION

[0009] Considered herein are various devices, systems, and methods for performing various bone treatment procedures, including separable driver devices connectable to fixation devices (or combinations thereof) that can be used in a one-step process for insertion into a target bone. Further embodiments relate to stabilization devices that can be used in combination with a combination of a driver device and a fixation device to maintain the connection between the driver device and the fixation device and help stabilize that connection during use.

[0010] In Example 1, the bone fixation device comprises a fixed segment and a separable driver segment. The fixed segment comprises an elongated non-cannulated fixation shaft having a diameter of less than about 5 mm, a sharp distal tip, and a proximal head having a first connection structure, and the proximal head has a proximal flat surface including a diameter larger than the diameter of the elongated fixation shaft. The separable driver segment comprises an elongated driver shaft having a diameter of less than about 5 mm, and a distal head having a distal flat surface and a second connection structure, and the second connection structure is separably connectable to the first connection structure, and the distal flat surface is engageable with the proximal flat surface.

[0011] Example 2 relates to the device according to Example 1, and the elongated fixation shaft comprises an outer surface having threads. Example 3 relates to the device according to Example 1, the first connection structure is a female connection structure, and the second connection structure is a male connection structure.

[0012] Example 4 relates to the device according to Example 3, the female connection structure comprises an opening defined in the proximal flat surface of the proximal head, the male connection structure comprises a ribbed protrusion extending from the distal flat surface, and the male connection structure is engageable with the opening defined in the proximal flat surface.

[0013] Example 5 relates to the device according to Example 1, and the sharp distal tip comprises a self-tapping tip. Example 6 relates to the device according to Example 1, the proximal head comprises a distal surface having a curved convex shape, and the distal head comprises a proximal surface having a curved convex shape.

[0014] Example 7 relates to the device according to Example 1, and further includes a stabilization device removably connectable to a fixed segment and a separable driver segment. The stabilization device includes an elongated body having a lumen defined therethrough, at least one distal flexible retaining structure disposed within the lumen, and at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure. The stabilization device is positionable over the fixed segment and the separable driver segment such that a proximal head and a distal head are disposed within the lumen between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure.

[0015] In Example 8, the bone fixation device includes a fixed segment, a separable driver segment, and a stabilization device. The fixed segment includes an elongated non-cannulated threaded fixation shaft having a diameter of less than about 5 mm, a sharp distal tip, and a proximal head having a first connection structure. The proximal head has a proximal flat surface including a diameter larger than the diameter of the elongated fixation shaft. The separable driver segment includes an elongated driver shaft having a diameter of less than about 5 mm, and a distal head having a distal flat surface and a second connection structure. The second connection structure is separably connectable to the first connection structure, and the distal flat surface is engageable with the proximal flat surface. The stabilization device includes an elongated body having a lumen defined therethrough, at least one distal flexible retaining structure disposed within the lumen, and at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure. The fixed segment and the separable driver segment are positionable through the lumen of the stabilization device such that the proximal head and the distal head are connected together and disposed between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure for transportation, storage, and use of the bone fixation device.

[0016] Example 9 relates to the device according to Example 8, wherein the first connection structure is a female connection structure and the second connection structure is a male connection structure. Example 10 relates to the device according to Example 9, the female coupling structure includes an opening defined in the proximal flat surface of the proximal head, the male coupling structure includes a ribbed protrusion extending from the distal flat surface, and the male coupling structure is engageable with the opening defined in the proximal flat surface.

[0017] Example 11 relates to the device according to Example 8, and the sharp distal tip includes a self-tapping tip. Example 12 relates to the device according to Example 8, the proximal head includes a distal surface having a convex curvature, and the distal head includes a proximal surface having a convex curvature.

[0018] In Example 13, a method of implanting a fixation device into a target bone includes positioning a combination device at a desired location in the target bone. The combination device includes a fixation device having an elongate non-cannulated fixation shaft having a diameter of less than about 5 mm and a proximal head having a diameter larger than the diameter of the elongate fixation shaft, and a separable driver device. The method further includes inserting the fixation device into the target bone by rotating the separable driver device in a first direction using a power driver tool until the proximal head is flush with the outer surface of the target bone, and separating the separable driver device from the fixation device.

[0019] Example 14 relates to the method according to Example 13, and the positioning of the combination device and the insertion of the fixation device are performed without using any pre-drilling, tapping, countersinking, measuring, or use of a guide wire.

[0020] Example 15 relates to the method according to Example 13, and further includes providing the combination device before positioning the combination device at a desired location in the target bone, and the separable driver device is coupled to the fixation device.

[0021] Example 16 relates to the method according to Example 15, and further includes packing, transporting, and / or storing the combined device while the separable driver device is coupled to the fixed device.

[0022] Example 17 relates to the method according to Example 13, and further includes reattaching the separable driver device and rotating the separable driver device in a second direction to retract the fixed device relative to the target bone by a certain length.

[0023] Example 18 relates to the method described in Example 17, and retracting the fixed device includes retracting the fixed device completely from the target bone. Example 19 relates to the method described in Example 13, and further includes positioning the combined device through a stabilization device before inserting the fixed device into the target bone. The stabilization device includes an elongated body defining a lumen through the elongated body, at least one distal flexible retaining structure disposed within the lumen, and at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure. The proximal head and the distal head are connected together and are disposed between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure.

[0024] Example 20 relates to the method described in Example 19, and inserting the fixed device into the target bone further includes rotating the separable driver device in a first direction until the proximal head exits the stabilization device.

[0025] Although a plurality of embodiments are disclosed, still other embodiments will be apparent to those of ordinary skill in the art from the following detailed description which illustrates and describes the exemplary embodiments. As implemented, the various implementations are capable of being modified in various obvious respects without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0027] Embodiments of various separable bone fixation devices herein relate to devices, systems, and methods that include a fixation device and a removably connectable driver device that can be used in combination to implant the fixation device in a one-step process. According to additional implementations, the devices, systems, and methods herein can also include a stabilization and / or guide device that can be coupled to the fixation device and the removably connectable driver device, such that the stabilization / guide device not only serves to maintain the connection between the fixation device and the driver device, but also serves to guide and stabilize them when the fixation device and the driver device are used in a one-step bone-related procedure.

[0028] In certain implementations, the various fixation and driver devices disclosed or contemplated herein incorporate the important advantages of three standard bone fixation devices, namely, K-wires, olive wires, and fixation screws, while overcoming some of their drawbacks. Implementations herein provide one-step insertion (different from fixation screws), bone compression (different from K-wires), elimination of proximal wire sections protruding from bone / skin (different from K-wires or olive wires), easy tightening adjustment (different from K-wires or olive wires), easy removal (different from K-wires), and optionally being implanted temporarily or permanently (different from K-wires or olive wires). Further, various implementations herein relate to a combination device including both a driver device and a fixation device that are removably coupled together prior to use and can be decoupled as desired.

[0029] An embodiment of a combination bone fixation device 10 is shown in FIG. 1A, and the combination bone fixation device 10 has two components, namely, an insertable fixation device (or “fixation segment,” “fixation screw,” or “fixation pin”) 12 and a separable driver device (or “driver segment” or “driver pin”) 14 for driving the fixation device 12 into or removing it from a target bone. The fixation device 12 is a threaded device 12 that can be a screw, pin, wire, rod, or any other similar component for use as a threaded fixation device to facilitate insertion into bone. Further, as will be described in more detail below, some exemplary fixation device implementations 12 disclosed or contemplated herein can be inserted into bone without any pre-drilling or any other preliminary steps to prepare the target area prior to inserting the fixation device 12. In other words, each such fixation device 12 can be inserted into the target area of the bone in a single step.

[0030] According to certain implementations, the combination device 10 can include a fixed device 12 and a driver device 14 that are detachably coupled together for immediate use. Further, in some exemplary embodiments, the combination device 10 can be provided in this coupled configuration in a package that is delivered to a treatment area (e.g., an operating room, etc.), such that when the device 10 is removed from the package by a surgeon or other user, the fixed segment 12 and the driver segment 14 are detachably coupled together.

[0031] As shown in FIG. 1B, certain system implementations can include a set of fixed devices 16 of different sizes provided with a driver device 14 (e.g., device 14 of FIG. 1A, etc.). Thus, in certain examples, a surgeon or other user has access to a complete set 16 of the driver device 14 and fixed devices 12A - 12E, where each of the fixed devices 12A - 12E is a different size that may be required for the specific procedure being performed. Further, according to various specific exemplary embodiments, the system includes a package that houses the device 14 and the set 16 of fixed devices. Alternatively, the system can include a package that houses the combination device 10 of FIG. 1A (where the driver device 14 is already coupled to one of the fixed devices 12), the devices 12A - 12E of different sizes, and a complete set 16 of fixed devices that can include several overlapping devices 12A - 12E of the same size.

[0032] As shown in FIGS. 2A-2E, one exemplary fixation device 20 has an elongated shaft 22, a sharp distal tip 24 at the distal end of the shaft 22, and a proximal head 26 at the proximal end of the shaft 22. In this embodiment, the device 20 is non-cannulated (i.e., there is no lumen or cannula defined along the length of the device 20 for the purpose of positioning the device 20 over a guidewire). The outer surface of the shaft 16 has threads 28 disposed along the entire length of the shaft 22 (as shown). The distal tip 24 (as best shown in FIGS. 2A and 2D) is sharp enough to be inserted through the patient's skin and into bone without first having to form a hole in the bone. That is, the tip 24 is a "self-tapping" tip 24 or operates to enable self-tapping of the fixation device 20. For example, in certain embodiments, the tip 24 is shaped like a self-tapping tip on, for example, a K-wire or Steinmann pin. Such a tip 24 can take various configurations including, for example, a trocar tip, a diamond tip, and the like. The term "self-tapping" as used herein to describe the tip 24 is intended to mean that the tip 24 is configured to incise the target cortical bone in the same manner as a drill bit, K-wire, or olive wire without the use of a prior preparation step (such as pre-perforation or the like) with respect to the target area.

[0033] In certain embodiments, such as the example depicted in FIGS. 2A and 2B, the proximal head 26 has a curved convex shape at its distal side portion 26A, is flat at the proximal side portion 26B, and has a female coupling feature 30 defined in the proximal side portion 26B (best shown in FIGS. 2B and 2C and further discussed in detail below). In other words, the proximal head 26 is shaped like half of a sphere (i.e., a "hemisphere"). In many implementations, the female coupling feature 30 is an opening 30 defined in the proximal side portion 26B of the head 26 and can receive and separably engage a male coupling feature (e.g., feature 48 discussed below) of a driver device (e.g., device 40). Alternatively, the proximal head 26 can be any structure having any shape as long as it has a diameter larger in structure than the shaft 22, a flat surface on the proximal side portion 26B of the head 26, and a coupling structure or feature 30 defined therein.

[0034] Any of the embodiments of the various fixation devices disclosed or contemplated herein, including the various implementations discussed below, can have the same or similar components, features, and / or functions.

[0035] As shown in FIGS. 3A - 3D, one exemplary embodiment of a separable driver device 40 has an elongate shaft 42 with a mating distal tip 44 at its distal end. The elongate shaft 42 is typically smooth or substantially smooth. The distal tip 44 can have a head 46 with an associated male coupling feature 48. More specifically, in the exemplary embodiment shown, the head 46 has a curved convex shape at its proximal side portion 46B, is flat at its distal side portion 46A, and from which the male coupling feature 48 extends. In other words, the distal head 46 is shaped like half of a sphere (i.e., a "hemisphere") reflecting the hemispherical proximal head 26 discussed above. Alternatively, the distal tip 44 can be any structure having any shape as long as it has a coupling structure or feature for connecting to the proximal head 26, as further discussed in detail below.

[0036] According to certain implementations, the driver device 40 can also have attachment features 50A-50C defined on the proximal portion of the shaft 42, as shown in FIGS. 3A and 3D. More specifically, in the specific implementation of FIG. 3D, the shaft 42 has three attachment features 50A-50C defined along the proximal length of the shaft 42. The three attachment features 50A-50C are elongated flat segments 50A-50C defined on the proximal length of the shaft 42. Thus, a known operable driver device (not shown) can be positioned over the proximal portion of the shaft 42 and attached to the attachment features 50A-50C such that the driver device can rotate the shaft 42 as a result of the attachment to the attachment features 50A-50C.

[0037] Any of the various driver device embodiments disclosed or contemplated herein, including the various implementations discussed below, can have the same or similar components, features, and / or functions.

[0038] In one exemplary embodiment, as shown in FIGS. 2B, 2C, 3B, and 3C, the female coupling feature 30 of the fixation device 20 and the male coupling feature 48 of the driver device 40 are Torx®-compatible drive components. That is, the female coupling feature 30 is an opening 30 defined in the proximal portion 26B of the head 26, with a feature 32 defined or disposed on the inner surface of the opening 30, as best shown in FIG. 2C. Similarly, the male coupling feature 48 is a protrusion 48 with a feature 52 defined or disposed on the outer surface of the protrusion 48, as best shown in FIG. 3C. The feature 52 of the protrusion 48 is sized and shaped to mate with the feature 32 of the opening 30 when the driver device 40 is coupled to the fixation device 20. More specifically, in this particular implementation, the feature 52 is a rib 52 that fits within the feature 32 of the opening 30, which is a channel 32 sized to receive the rib 52. Alternatively, the coupling features 30, 48 can be any known connectable male and female structures, without limitation as to the position of the male and female structures on the insertable fixation device 20 and the separable driver device 40. In a further alternative, the coupling features of the two connectable segments 20, 40 can be any known coupling components that enable coupling and decoupling of the two segments 20, 40 during use, as described herein. Any of the various embodiments disclosed or contemplated herein, including the various implementations discussed below, can have the same or similar coupling features.

[0039] In certain implementations, the opposing flat surfaces 26B, 46A of the two heads 26, 46 serve to facilitate and stabilize the connection of the two devices 20, 40. More specifically, when the male connection feature 48 of the driver device 40 is inserted into the female connection feature 30 of the fixed device 20 and the distal head 46 is biased distally to contact the proximal head 26, the flat surface 46A contacts the flat surface 26B. Because of the flat surfaces 26B, 46A, when the two heads 26, 46 are in contact, the two devices 20, 40 cannot easily rotate radially relative to each other at the junction of the two connection features 30, 48. That is, the two flat surfaces 26B, 46A facilitate the alignment of the two devices 20, 40 such that when the two flat surfaces 26B, 46A are in contact with each other, the longitudinal axes of each of the devices 20, 40 are urged into a coaxial configuration (such as that shown in FIG. 1A, for example). In contrast, if either or both of the surfaces 26B, 46A are rounded or convex (in a manner similar to the surfaces 26A, 46B, for example), the surfaces do not bias the two devices into a coaxial configuration when they are in contact and, in fact, allow the two devices to rotate radially relative to each other at the junction of the two surfaces. Thus, the two mating flat surfaces 26B, 46A serve to prevent the two devices 20, 40 from "tilting" or otherwise moving radially relative to each other during use. In one exemplary embodiment, each of the two flat surfaces 26B, 46A has a diameter of at least 1.5 mm.

[0040] Furthermore, in any of the various embodiments disclosed or contemplated herein, where both the distal head (such as head 46) and the proximal head (such as head 26) are hemispherical in shape, when two heads pair up by connecting two connecting features (such as features 30, 48), a complete sphere is formed by the two heads, and a complete combined device (such as device 10) is formed by two devices (such as devices 10, 12 or devices 20, 40). The two connecting features 30, 48 are also separable from each other when a separable driver device (such as device 14 or 40) is retracted proximally or otherwise operated by the user such that the connecting feature 48 is disengaged from the connecting feature 30. Alternatively, the connecting feature 48 can be disengaged from the connecting feature 30 in any known manner. Any of the various embodiments disclosed or contemplated herein, including the various implementations discussed below, can have the same or similar connecting features.

[0041] According to a particular implementation, either of the two devices (e.g., devices 12, 14, or devices 20, 40) can be made of stainless steel or a titanium alloy. In one specific embodiment, the two devices 12, 14, or 20, 40 are made of 316L surgical stainless steel. Alternatively, the two devices 12, 14, or 20, 40 can be made of any suitable metal or combination of metals used in bone fixation devices.

[0042] In some embodiments, any of the insertable fixation devices (such as devices 12 and 20) of this specification can have a length in the range of about 6 mm to about 80 mm. Further, any of the separable driver devices (such as devices 14 and 40) can have a length in the range of about 10 cm to about 20 cm. Additionally, each of the elongated shafts (such as shaft 22) of the fixation device (such as device 12 or 20) and the elongated shafts (such as shaft 42) of the driver device (such as device 14 or 40) can have a diameter in the range of about 1.2 mm to about 4 mm. Further, each of the proximal heads (such as head 26) of the fixation device (such as device 12 or 20) and the distal heads (such as head 46) of the driver device (such as device 14 or 40) can have a diameter in the range of about 3 mm to about 6 mm at its maximum diameter.

[0043] In certain implementations, one or more of the fixed devices used within the systems described or contemplated herein can have threads disposed or defined only along a portion of their length. For example, in the embodiments of FIGS. 4A - 4B, the fixed device 60 has a non-cannulated elongated shaft 62, a sharp distal tip 64 at the distal end of the shaft 62, and a proximal head 66 at its proximal end. Except as considered herein, the components and features of the fixed device 60 are substantially similar to those of other fixed device embodiments herein and function in substantially the same manner. In this exemplary implementation, the outer surface of the shaft 62 has threads 68 disposed along the threaded portion 70 of the shaft 62 (as shown), and also has a portion 72 without threads 68. More specifically, the threaded portion 70 in this exemplary embodiment is the distal threaded portion 70 of the shaft 62, while the non-threaded or “smooth” portion 72 is the proximal portion 72 of the shaft 62. Even more specifically, the threads 68 are disposed along the distal half 70 of the shaft 62, and the smooth portion 72 is the proximal half 72 of the shaft 62. Alternatively, the threaded portion 70 can be any portion of the shaft 62 that is shorter than the full length of the shaft 62. Further, the proximal head 66 is shaped like a hemisphere having a flat surface on a proximal side portion 66B that is substantially similar to the proximal side portion 26 considered above. Alternatively, the proximal head 66 can be any structure having any shape, so long as it has a diameter larger in structure than the shaft 62, a flat surface on the proximal side portion 66B of the head 66, and a connection structure or feature 74 defined therein.

[0044] In a further embodiment, one or more fixation devices used within the systems described or contemplated herein can have threads disposed along the entire length of a device that includes not only a shaft but also a proximal head. For example, in the embodiments of FIGS. 5A - 5C, the fixation device 80 has a non - cannulated elongated shaft 82, a sharp distal tip 84 at the distal end of the shaft 82, and a proximal head 86 at its proximal end. Except as considered herein, the components and features of the fixation device 80 are substantially similar to and function in substantially the same manner as the other fixation device embodiments of this specification. In this exemplary implementation, the device 80 has threads 88 disposed around the outer surfaces of the shaft 82 and the proximal head 86 as shown. More specifically, the threads 88 in this exemplary embodiment are disposed along the entire length of the device 80 that includes the shaft 82 and the proximal head 86. Alternatively, the device 80 can have threads 88 that are disposed around only a portion of the shaft 82 but in a similar manner as the device 70 described above around the entire proximal head 86. Further, the proximal head 86 has a flat surface on the proximal side portion 86B that is substantially similar to the proximal heads 26, 76 considered above. Alternatively, the proximal head 86 can have any structure with any shape as long as the structure has a diameter larger than the shaft 82, a flat surface on the proximal side portion 86B of the head 86, threads 88 disposed around the proximal head 86, and a connection structure or feature 90 defined therein.

[0045] Another implementation of the combined bone fixation device 100 is shown in FIGS. 6-8B. The combined bone fixation device 100 includes an insertable fixation device 102 and a separable driver device 104 for driving the fixation device 102 into or removing it from the target bone. Unless explicitly described herein, the various components, features, and functions of the fixation device 102 and the driver device 104 may be the same as or substantially similar to the embodiments of the fixation and driver devices disclosed or contemplated elsewhere in this specification, including the embodiments of the fixation devices 12, 20, 60, 80 and the driver devices 14, 40 described in detail above.

[0046] In the specific exemplary embodiments shown in FIGS. 6-8B, the combined device 100 can be provided with a fixation device 102 and a driver device 104 that are separably coupled together for immediate use in a manner similar to that described above with respect to the fixation device 12 and the driver device 14. Further, in certain implementations, the device 100 can be part of a system having a plurality of fixation devices (such as device 12) of different sizes in a manner similar to that described above with respect to FIG. 1B.

[0047] As best shown in FIG. 7, an exemplary fixation device 102 has a non-cannulated elongated shaft 106, a sharp distal tip 108 at the distal end of the shaft 106, and a proximal head 110 at the proximal end of the shaft 106. The outer surface of the shaft 106 has threads 112 disposed along the entire length of the shaft 106 (as shown). The distal tip 108 is a self-tapping tip 108 or operates to enable self-tapping into the fixation device 102 in a manner similar to the device 20 discussed above. In certain embodiments, such as the examples depicted in FIGS. 7, 8A, and 8B, the proximal head 110 has a hemispherical shape with a curved convex shape at the distal side portion 110A, is flat at the proximal side portion 110B, and has a female coupling feature 114 defined in the proximal side portion 110B in a manner similar to the proximal head 26 discussed in detail above (as best shown in FIG. 8A). Alternatively, the proximal head 110 can be any structure having any shape as long as it has a diameter larger than that of the shaft 106, a flat surface on the proximal side 110B of the head 110, and a coupling structure or feature 114 defined therein.

[0048] As best shown in FIGS. 6 and 8B, one exemplary embodiment of a separable driver device 104 has an elongated shaft 116 with a distal tip 118 that is engageable at the distal end of the shaft 116 with a head 120 having a male coupling feature 122 associated with the separable driver device 104. In the exemplary embodiment shown, the head 120 has a curved convex shape at its proximal side portion 120B, is flat at its distal side portion 120A, and the male coupling feature 122 extends therefrom in a manner similar to the distal head 46 discussed in detail above. Alternatively, the distal tip 118 can be any structure having any shape as long as it has a coupling structure or feature for coupling to the proximal head 110, as will be discussed in more detail below. According to certain implementations, the driver device 104 can also have attachment features (not shown) defined or disposed in the proximal portion of the shaft 116 similar to the attachment features 50A - 50C discussed above.

[0049] In one exemplary embodiment, as best shown in FIGS. 8A and 8B, the female coupling feature 114 of the fixed device 102 and the male coupling feature 122 of the driver device 104 can be Torx®-compatible drive components in a manner similar to the female coupling feature 30 and male coupling feature 48 discussed above. Alternatively, the coupling features 114, 122 can be any known connectable male and female structures without limitation to the positions of the male and female structures on the insertable fixed device 102 and separable driver device 104.

[0050] In certain implementations, the opposing flat surfaces 110B, 120A of the two heads 110, 120 serve to facilitate and stabilize the connection of the two devices 102, 104 in the same or a similar manner as described above for the flat surfaces 26B, 46A. Further, the distal head 120 and proximal head 110 are both shaped like hemispheres such that when the two heads 120, 110 are paired by connecting the two coupling features 114, 122, a complete sphere is formed by the two heads 120, 110 and a complete combined device (such as device 100) is formed by the two devices 102, 104 in a manner similar to that described above. The two coupling features 114, 122 are also separable from each other when the separable driver device 104 is retracted in the proximal direction or when operated by the user such that the coupling feature 122 is disengaged from the coupling feature 114 in a manner similar to that described above.

[0051] According to certain implementations, the two devices 102, 104 can be made of any metal or combination of metals and can have the same or similar dimensions as in the previous embodiments as discussed above.

[0052] In use, any of the various embodiments of the fixation devices disclosed or contemplated herein can be used in a variety of bone-related procedures including, but not limited to, fracture stabilization, plate stabilization, and bone reconstruction. The device 100 discussed above is used as an exemplary device for purposes of explaining the following exemplary procedure steps, but any of the various device embodiments disclosed or contemplated herein can be used to perform a variety of bone-related procedures. As discussed elsewhere herein, in various implementations, the device 100 can be provided as a combined device 100 in which a fixation device 102 and a driver device 104 are coupled together. More specifically, the device 100 can be packaged, shipped, stored, ultimately removed from the packaging, and prepared for use in a procedure in this coupled configuration, thereby simplifying the use of the device 100 by eliminating the need for the user to remove two different devices from the packaging and couple them together prior to the procedure.

[0053] Once the combination device 100 is removed from its packaging and all preparations for the desired procedure have been made, the device 100 can be coupled to a known electric driver device (not shown), the distal tip 108 of the fixation device 102 can be positioned at the target location on the bone, and the electric driver device can be actuated to drive the fixation device 102 into the bone such that the proximal head 110 contacts the bone. In some implementations, the fixation device 102 can be driven distally into the bone such that the head 110 is embedded within the bone flush with the surface of the bone. As discussed elsewhere herein, this step of driving the fixation device 102 into the bone is a single-step process that eliminates many of the steps required for known devices. That is, unlike known devices and related procedures, there is no need to perform measurements, pre-drilling, guide wire placement, over-drilling, tapping, countersinking, use of a screwdriver (unless adjustment is desired), cutting or capping of the proximal end of the fixation device (such as required with an olive wire), or subsequent removal of the fixation device and insertion of a permanent screw (such as required with a K-wire). Instead, the combination device 100 enables a one-step process in which the device 100 is coupled to an electric driver device (not shown), positioned at the desired location, and the fixation device 102 is biased into the target bone.

[0054] Accordingly, in certain implementations as described above, the one-step procedure involves inserting the combination device 100 into the target bone using a known electric driver device. In certain embodiments, initially, a small guide hole can be formed in the target bone using known devices and methods. The sharp distal tip 108 of the fixation segment 102 is positioned within the guide hole, and the electric driver device is attached to the driver segment 104 such that actuation of the wire driver device rotates the driver segment 104, thereby rotating the attached fixation segment 102. In one embodiment, the driver device rotates the device 100 in a clockwise direction. Alternatively, a small guide hole is not necessary.

[0055] When the distal tip 108 penetrates the bone, the shaft 106 of the fixation segment 102 begins to penetrate the bone. As discussed above, in various implementations, the outer surface of the shaft 106 is threaded, such that when the shaft 106 rotates, the threads 112 establish connection with the bone, thereby establishing “purchase” and driving the shaft 106 through. Due to the small diameter of the fixation segment 102 (as discussed above), bone extraction or destruction is minimized. As the fixation segment 102 is further inserted, the proximal head 110 contacts the cortex of the bone (the outer surface of the bone). Considering its wider diameter compared to the shaft 106, the proximal head 110 provides compression against the surface of the bone. Thus, the proximal head 110 provides advantages for fracture management (compared to K-wires and other fixation wires without a head or “olive”), because two bone fragments can be held using any of the embodiments of the fixation device herein, and compression between the two bone fragments can be achieved. Alternatively, the implant can be used to temporarily fix the two bone fragments at the fusion site before permanent fixation is achieved.

[0056] In one embodiment, the electric driver device can be the TPX® Universal Driver commercially available from Stryker. Alternatively, the electric driver device can be any known electric device (such as any of the drivers from Depuy Synthes, Hall, etc.) for connecting to a temporary or permanent fixation device during any bone procedure as contemplated herein and driving such a fixation device into the target bone.

[0057] Once the fixation segment 102 has been advanced to the point where the proximal head 110 contacts the cortical bone, the segment 102 can be advanced such that the proximal head 110 sinks or is embedded into the bone. In certain embodiments, the head 110 can be advanced into the bone such that the proximal side portion 110B of the head 110 is flush with the surface of the bone or otherwise does not protrude from the bone. Further, according to various implementations, the distal side portion 110A of the proximal head 110 has cutting flutes (not shown) defined therein (or otherwise disposed thereon) that allow the head 110 to countersink into the bone. Alternatively, the head 110 can have any other known mechanism or feature that allows the head 110 to be embedded into the bone. At this point, the driver segment 104 can be separated from the fixation segment 102, leaving only the embedded fixation segment 102 without anything protruding above the surface of the bone. In contrast, with a conventional olive wire, even after some proximal portions of the olive wire have been cut or bent, the wire typically has at least the standard olive protruding from the bone and, in many cases, at least a portion of the proximal wire further protruding. Alternatively, in certain implementations where the device 100 is used for temporary fixation, the proximal head 110 does not need to be embedded flush with the surface of the bone. The driver segment 104 can be separated simply by moving the driver segment 104 in the proximal direction to disengage the coupling feature 122 of the driver segment 104 from the coupling feature 114 of the fixation segment 102.

[0058] Once the fixation segment 102 is implanted as desired, the next step may depend on the success of the insertion of segment 102, the type of procedure, and / or whether segment 102 is to be removed or permanently implanted. For example, if the surgeon is not satisfied with the insertion of the fixation segment 102 or the resulting position, the surgeon can use the driver segment 104 to adjust the tension, depth, or position of the fixation segment 102. In other words, if the surgeon wishes to "loosen" the fixation segment 102 by some length or otherwise retract it, the surgeon reattaches (or maintains its attachment) the driver segment 104 and, in certain implementations, uses a powered driver tool to rotate the driver segment 104 (and thus the fixation segment 102) in the reverse direction, thereby moving the fixation segment 102 proximally relative to the bone and thereby retracting the segment 102. Alternatively, if the surgeon wishes to "tighten" the fixation segment 102 or otherwise insert it further into the bone, the surgeon uses the driver tool to rotate the driver segment 104 (and thus the fixation segment 102) in the same direction as during insertion, whereby the fixation segment 102 can be further penetrated deeper into the bone. In a further alternative, if the surgeon completes the remainder of the bone correction procedure (e.g., including the insertion of permanent fixation screws) and does not intend to retain the fixation segment 102 within the bone, the surgeon can then reattach the driver tool to the driver segment 104 and use it to fully retract the fixation segment 102 by biasing the driver segment 104 (and thus the fixation segment 102) in the opposite direction until it is fully retracted from the bone. In contrast, various known devices (such as K-wires, snap-off screws, and the like) cannot be loosened, tightened, or easily removed via a separable driver such as those described herein.

[0059] According to certain treatment embodiments, the embodiments of any device herein can be used to fix a fixation plate to bone. For example, a fixation plate (not shown) can be positioned in contact with a target bone region as desired, and a device (such as device 100) can be inserted through an opening in the plate. More specifically, the distal end 108 of the fixation segment 102 is inserted through the opening. At this point, both the device 100 and the plate can be positioned more accurately as desired. When the fixation segment 102 advances through the bone, ultimately the proximal head 110 of the segment 102 contacts the outer surface of the plate, thereby firmly fixing the plate to the bone. In various embodiments, at this point, the position of the plate can be evaluated (such as by using an image intensifier, etc.) to ensure the desired position within the body. If, as a result of this evaluation, the position of the plate is determined not to be ideal, the device 100 can be retracted as described above, the plate can be repositioned, and this process can be repeated.

[0060] In certain embodiments as described above, the fixation segment 102 can be left in the bone as a permanent implant. The ability to insert the segment 102 such that the proximal head 110 is flush with the outer surface of the bone and then remove the driver segment 104 allows the fixation segment 102 to be a permanent fixation device. Thus, according to some embodiments, the device 100 can be used permanently in combination with other fixation screws and / or fixation plates and can therefore be used as a hybrid fixation structure. For example, one or more devices 100 can function as additional fixation points across the surface of the fixation plate with minimal additional time or expense.

[0061] In embodiments of any use or method disclosed or contemplated herein, device 10 can be provided with a fixed segment 12 and a driver segment 14 detachably coupled together for immediate use. Further, in some exemplary embodiments, device 10 can be provided in this coupled configuration in a package that is delivered to a treatment area (e.g., an operating room, etc.), such that when device 10 is removed from the package by a surgeon or other user, fixed segment 12 and driver segment 14 become detachably coupled together.

[0062] Embodiments of the various devices disclosed or contemplated herein enable a surgeon to insert device 10 into bone with the ease of a standard K-wire or olive wire, while also enabling the surgeon to separate, and in some cases reattach, driver segment 14 to facilitate manipulation, adjustment, or removal. Further, as described above, implementations herein do not require various steps of a fixation screw (pre-drilling, countersinking, depth measurement, counterboring, tapping for insertion, etc.). Additionally, embodiments of the fixation device 10 herein enable performance of the various bone fixation procedures described herein without the risks of interfering bent wires, cut wires, or long or sharp wires that are common with standard olive wires.

[0063] In certain embodiments, a device can be used to help maintain a separable connection between the driver and the fixation device during transportation of the driver and fixation device, as well as before and during use. For example, FIGS. 9A-9H depict an attachment stabilization device 130 that can couple a driver device 134 and a fixation device 132, thereby helping to maintain their connection and thereby forming a three-component combination device 128, as discussed in more detail below. Driver device 134 represents any of the driver device embodiments disclosed or contemplated herein, and fixation device 132 represents any of the fixation device embodiments disclosed or contemplated herein.

[0064] Driver device 134 and fixation device 132 can be disposed through a lumen 131 defined within stabilization device 130, as shown in FIGS. 9A-9H, such that driver device 134 and fixation device 132 are interconnected within lumen 131, resulting in the three-component combination device 128 described above. Accordingly, the distal end of fixation device 132 (including distal tip 136) extends from lumen 131 and from the distal end of stabilization device 130, while the distal end of driver device 134 (including distal head 138 and male coupling feature 140) is disposed within lumen 131 of stabilization device 130 and is coupled to proximal head 142 such that male coupling feature 140 is disposed within and coupled to female coupling feature 144. More specifically, when stabilization device 130 is positioned over driver device 134 and fixation device 132 to help stabilize and / or maintain attachment of the two devices 134, 132 as shown, the distal end of fixation device 132 extends from distal opening 146 of stabilization device 130, and driver device 134 is disposed through proximal opening 148 of stabilization device 130. Both distal opening 146 and proximal opening 148 are in fluid communication with lumen 131 such that openings 146, 148 provide access to lumen 131.

[0065] As described above, embodiments of the stabilization device 130 described herein are used to maintain a connection between any of the embodiments of the driver device and the fixation device disclosed or contemplated herein. Thus, the stabilization device 130 is used to maintain the driver (such as driver 134) and the fixation device (such as fixation device 132) in a connected configuration (three-component combination device 128) during packaging, transportation, storage, sterilization, and / or prior to use in a procedure. In fact, in certain embodiments contemplated below, the stabilization device 130 can also be used in combination with the driver device and the fixation device during the first step of the procedure.

[0066] Of course, the stabilization device is not limited to use in the embodiments of the driver device and the fixation device of this specification. That is, various embodiments of the stabilization device disclosed or contemplated herein can be used to maintain the connection and stability of any similar implant having a fixation device and a driver device or equivalent components.

[0067] Figures 10A - 10H depict one exemplary embodiment of the stabilization device 130. The device 130 has an elongated body 150 with a lumen 131 defined therethrough, as discussed above. The body 150 has a distal section 150A, a proximal section 150B, and in certain embodiments discussed in further detail below, an expansion section 166 disposed between and connecting the distal section 150A and the proximal section 150B. In certain implementations, the stabilization device 130 has retention structures 160, 162 disposed within the lumen 131 for connecting and holding the driver device 134 and the fixation device 132 to each other.

[0068] More specifically, according to one embodiment, the stabilization device 130 has at least two flexible proximal retention protrusions 160 disposed within the lumen 131. In a particular implementation, the proximal retention protrusions 160 are disposed within the lumen 131 along the length of the lumen 131 such that they are closer to the proximal opening 148 than to the distal opening 146. In the exemplary embodiments best depicted in FIGS. 9F, 9G, 9H, 10D, 10F, and 10H, as shown, the stabilization device 130 has four proximal retention protrusions 160 disposed around the circumference of the lumen 131 and extending radially from the inner wall of the lumen 131 toward the center of the lumen 131. As best shown in FIGS. 9F - 9H, the inner diameter of the opening defined by the proximal protrusions 160 is smaller than the outer diameter of the distal head 138 of the driver device 134. Thus, the proximal protrusions 160 serve to retain the distal head 138 of the driver device 134 within the lumen 131 of the device 130, as shown in FIGS. 9F and 9G. Further, in a particular embodiment, the protrusions 160 are radially flexible and / or compressible such that the distal head 138 of the driver device 134 (and / or any other device having an outer diameter larger than the inner diameter defined by the protrusions 160) can be urged beyond the protrusions 160 when a sufficient external force is applied to the driver device 134 such that the distal head 138 urges beyond the protrusions 160.

[0069] Furthermore, the stabilization device 130 can also have at least two flexible distal retention structures 162 disposed within the lumen 131. According to certain embodiments, the distal retention structures 162 are disposed within the lumen 131 along the length of the lumen 131 such that they are disposed on the distal side of the proximal protrusion 160. In the exemplary embodiments best depicted in FIGS. 9F, 10D, and 10H, the stabilization device 130 has two distal retention structures 162 disposed on both sides of the lumen 131 as shown and extending radially toward the center of the lumen 131. More specifically, in the exemplary implementations of FIGS. 9A - 10H, the two distal retention structures 162 are flexible bellows 162, and the flexible bellows 162 extend axially between the distal section 150A and the proximal section 150B and have at least one fin 164 of the bellows 162 extending radially toward the center of the lumen 131 as shown. More specifically, the distal end of the bellows 162 is attached to (or is integral with) the distal section 150A as best shown in FIGS. 10D and 10H, and the proximal end of the bellows 162 is attached to (or is integral with) the proximal section 150B. Thus, the inner diameter of the opening defined by the distal retention structure 162 (in this case, the fin 164) is smaller than the outer diameter of the proximal head 142 of the fixation device 132. In this way, the distal fin 164 serves to hold the proximal head 142 of the fixation device 132 within the lumen 131 of the device 130 as shown in FIGS. 9F and 9G. Further, in certain embodiments, the fin 164 is flexible and / or compressible such that it can be biased to allow the proximal head 142 (and / or any other device or component having an outer diameter larger than the inner diameter defined by the fin 164) to pass over the fin 164 when a sufficient external force is applied to the fixation device 132 to bias the proximal head 142 to pass over the fin 164. Alternatively, the fin 164 can be any type of protrusion 164 extending from a bellows or similar structure.In a further alternative, the distal retention structure 162 is not a bellows, but instead can be any type of retention structure, projection, or the like that operates as described herein to assist in stabilizing the driver device 134 and the fixed device 132, including both axial and radial movement as contemplated.

[0070] According to certain implementations, the distal opening 146 of the stabilization device 130 discussed above can serve to provide stabilization to the driver device 134 and the fixed device 132. More specifically, in some embodiments, the distal opening 146 has an inner diameter sized to substantially match the outer diameter of the fixed device 132 (or its threads). Thus, when the fixed device 132 is positioned through the stabilization device 130 as described above, the inner diameter of the distal opening 146 contacts the outer diameter of the fixed device 132, whereby the distal opening 146 provides support or stabilization to the device 132 at points along the length of the device 132 that contacts the fixed device 132.

[0071] Furthermore, according to some embodiments, as best shown in FIGS. 9A, 9E, 10A, 10B, 10C, and 10D, the stabilization device 130 has a longitudinal slit 147 defined along the length of the distal section 150A of the body 150. The slit 147 allows the distal section 150A to expand radially. For example, as will be described in more detail below, when the proximal head 142 of the fixed device 132 and / or the distal head 138 of the driver device 134 are biased distally through the distal section 150A, the slit 147 allows the distal section 150A (and thus the lumen 131 therein) to expand radially, thereby enabling the proximal head 142 and / or the distal head 138 to pass through the distal section 150A.

[0072] As described above, the stabilization device 130 can be used to help maintain the connection between the driver device 134 and the fixation device 132. With regard to maintaining the connection between the two devices 134, 132, as best shown in FIGS. 9F and 9G, when the stabilization device 130 is positioned over the driver device 134 and the fixation device 132, the two retention structures 160, 162 are disposed on opposite sides of the coupled distal head 138 of the driver device 134 and the proximal head 142 of the fixation device 132. More specifically, the proximal retention structure 160 is disposed proximal to the distal head 138 so as to prevent the retention structure 160 from moving proximally (and thus disconnecting from the proximal head 142) of the distal head 138, unless sufficient force is applied such that the head 138 can radially outwardly bias the structure 160. Similarly, the distal retention structure 162 is disposed distal to the proximal head 142 so as to prevent the retention structure 162 from moving distally (and thus disconnecting from the distal head 138) of the proximal head 142, unless sufficient force is applied such that the head 142 can radially outwardly bias the structure 162.

[0073] In addition, the stabilization device 130 can also be used to help maintain the alignment of the longitudinal axes of the two devices 134, 132 while they are connected. That is, the stabilization device 130 can help prevent either of the devices 134, 132 from moving radially relative to each other. This restriction of radial movement is achieved, as described above, by the retention structures 160, 162 that contact them at the connection of the devices 134, 132 and by the inner diameter of the distal opening 146 of the device 130 that contacts the fixation device 132 as described above. Thus, the device 130 provides stabilizing contact with the two devices 134, 132 at two different points along its length, namely at the connection between the distal head 138 and the proximal head 142 (via the retention structures 160, 162) and at a point along the length of the fixation device 132, distally of the proximal head 142 (via the distal opening 146).

[0074] In various embodiments, the stabilization device 130 can also have an expansion section 166 having an outer diameter that is larger than the remainder of the body 150, as shown, on an elongated body 150. More specifically, the expansion section 166 is disposed between and attached to the distal section 150A and the proximal section 150B, and as a result of the expansion section having a larger outer diameter, extends radially outward from the body 150 more than either of these sections 150A, 150B. In certain implementations, as best shown in FIGS. 10A - 10C, the expansion section 166 is actually made up of two sections 166A, 166B that are on opposite sides of the circumference of the device 130, such that the two sections 166A, 166B are separated by a gap 167. Further, in certain implementations, the bellows 162 is disposed within the gap 167 as shown. In addition to making it easier for a user to grip the device 130, each of the expansion sections 166A, 166B forms a protection space for each of the bellows 162, the protection space being circumferentially defined by the gap 167 in which the bellows 162 is disposed and radially defined by the space 168 formed between the outer diameter of the expansion sections 166A, 166B and the bellows 162. Thus, each of the distal retention structures 162 is disposed within this protection space such that any force applied by a user gripping the expansion section 166 is prevented from being applied to the structure 162 while allowing the structure 162 to freely expand or contract during use.

[0075] In use, the stabilization device 130 can be used in combination with any of the embodiments of the various combination devices disclosed or contemplated herein to perform any of the bone-related procedures discussed above. A device 130 having a driver device 134 and a fixation device 132 as discussed above is used as an exemplary device for purposes of explaining the following exemplary treatment steps, but the device 130 and its reasonable variations can be used with any of the embodiments of the various combination devices disclosed or contemplated herein and can be used to perform various bone-related procedures. As discussed elsewhere in this specification, in various implementations, the stabilization device 130 can be used to assist in maintaining the state in which the fixation device 132 and the driver device 134 are connected together. Thus, in certain embodiments, the stabilization device 130 can be attached to or disposed around the fixation device 132 and the driver device 134, such that the stabilization device 130, the fixation device 132, and the driver device 134 form a three-component combination device 128 that can be packaged, shipped, stored, and ultimately removed from the package and prepared for use in a treatment in a connected configuration.

[0076] According to one embodiment, the first step is to attach the stabilization device 130 to the fixation device 132 and the driver device 134 to create a three-component combined device 128. More specifically, the fixation device 132 and the driver device 134 are first connected together as described elsewhere herein, and then the connected devices 132, 134 are inserted into the stabilization device 130 (or alternatively, the stabilization device 130 is inserted over the connected devices 132, 134 and positioned over the connection as described above). In one specific embodiment, the distal end 136 of the fixation device 132 is inserted distally through the proximal opening 148 of the stabilization device 130 and out of the distal opening 146 through the lumen 131, such that the fixation device 132 is biased distally through the device 130 until both the proximal head 142 and the distal head 138 are disposed between the distal retention structure 160 and the proximal retention structure 162 as contemplated above and depicted in FIGS. 9D, 9F, and 9G. That is, sufficient force is applied to the connected devices 132, 134 such that the proximal head 142 and the distal head 138 pass through the flexible proximal retention structure 160 in the manner contemplated above. Once the connected devices 132, 134 are positioned within the stabilization device 130 as intended to create the three-component combined device 128, the three-component combined device 128 can be packaged, shipped, stored, and ultimately removed from the package and prepared for use in a procedure in the connected configuration.

[0077] Once the three-component combination device 128 is removed from the packaging and all preparations for the desired procedure are made, the driver device 134 can be connected to a known electric driver device (not shown) in a manner similar to that described above. At this point, the surgeon (or other user) can hold the electric driver device in one hand and the three-component combination device 128 in the other hand while positioning the distal tip 136 of the fixation device 132 at the target location on the bone. In one embodiment, the surgeon grasps the stabilization device 130 at the expansion sections 166A, 166B. Once the distal tip 136 is positioned as desired, the surgeon activates the electric driver device to rotate the driver device 134 and the fixation device 132, thereby biasing the fixation device 132 into the bone. In one embodiment, the stabilization device 130 maintains the connection between the fixation device 132 and the driver device 134 and prevents either device 132, 134 from tilting or moving radially relative to the other while the surgeon applies a distal force to bias the fixation device 132 into the bone. In other words, the stabilization device 130 serves to keep the connected devices 132, 134 on the intended trajectory without either device 132, 134 tilting or moving radially relative to the other during the insertion process. As the fixation device 132 advances into the bone, the stabilization device 130 also advances distally until the distal end of the stabilization device 130 contacts the bone surface. When the distal end of the stabilization device 130 contacts the bone surface, the stabilization device 130 stops advancing distally, but the driver device 134 and the fixation device 132 continue to advance. Thus, due to the force applied by the electric driver device, the proximal head 142 and the distal head 138 continue to advance distally through the distal retaining structure 162 and out of the distal opening 146 of the device 130, thereby radially expanding the distal opening 146 as a result of the slit 147 until the proximal head 142 and the distal head 138 exit the distal opening 146. This radial expansion of the distal end of the stabilization device 130 functions for the surgeon as a visual indication that the proximal head 142 is in proximity to the surface of the bone in certain embodiments.Once the proximal head 142 and the distal head 138 exit the device 130, the stabilization device 130 can be removed or moved aside so that the surgeon has full visualization of the proximal head 142 and the driver device 134 during the final implantation of the fixation device 132. According to certain embodiments, the remaining steps are similar to those of the device implantation process without the stabilization device discussed above.

[0078] Although the various systems described above are separate implementations, any of the individual components, mechanisms, devices, or steps within the various system embodiments described in detail above, and the related features and functions, can be incorporated into any of the other system, device, or method embodiments herein.

[0079] As used herein, the terms "about" and "substantially" refer to variations that may occur through typical measurement techniques and equipment for any quantifiable variable, including but not limited to, for example, mass, volume, time, distance, wavelength, frequency, voltage, current, and electromagnetic fields (including numerical quantities or structures). Further, due to differences in the manufacturing, source, or accuracy of the components used to make the various components or implement the methods, there are likely to be certain incidental errors and variations in the real world. The terms "about" and "substantially" also encompass these variations. The terms "about" and "substantially" can include any variation of 5% or 10%, or any amount from 0% to 10% (including any integer). Further, whether or not modified by the term "about" or "substantially", the claims include equivalents to the quantity or amount.

[0080] The numerical ranges recited within this specification include 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. The description in range format is for convenience and brevity only 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 specifically disclose all possible sub-ranges, fractions, and individual numerical values within that range. For example, a description of a range such as 1 to 6 should be considered to specifically disclose sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as the individual numbers within the range, such as 1, 2, 3, 4, 5, and 6, and decimals and fractions, such as 1.2, 3.8, 1 1 / 2, and 4 3 / 4. This applies regardless of the breadth of the range. Although various embodiments have been described with respect to preferred implementations, those skilled in the art will recognize that changes may be made in form and detail without departing from their spirit and scope.

[0081] Although various embodiments have been described with respect to preferred implementations, those skilled in the art will recognize that changes may be made in form and detail without departing from their spirit and scope.

Claims

1. An osteofixation device, (a) a fixation segment comprising: (i) an elongate non-cannulated fixation shaft having a diameter of less than about 5 mm; (ii) a sharp distal tip; (iii) a proximal head having a first connection structure and a proximal flat surface having a diameter larger than the diameter of the elongate fixation shaft; and (b) a separable driver segment comprising: (i) an elongate driver shaft having a diameter of less than about 5 mm; (ii) a distal head having a distal flat surface and a second connection structure, the second connection structure being separably connectable to the first connection structure, and the distal flat surface being engageable with the proximal flat surface.

2. The device of claim 1, wherein the elongate fixation shaft has an outer surface with threads.

3. The device of claim 1, wherein the first connection structure is a female connection structure and the second connection structure is a male connection structure.

4. The device of claim 3, wherein the female connection structure comprises an opening defined in the proximal flat surface of the proximal head, the male connection structure comprises a ribbed protrusion extending from the distal flat surface, and the male connection structure is engageable with the opening defined in the proximal flat surface.

5. The device of claim 1, wherein the sharp distal tip includes a self-tapping tip.

6. The device of claim 1, wherein the proximal head has a distal surface with a convex curvature and a proximal surface with a convex curvature.

7. The device further comprises a stabilization device removably connectable to the fixed segment and the separable driver segment, the stabilization device comprising: (a) the elongated body having a lumen defined therethrough; (b) at least one distal flexible retaining structure disposed within the lumen; (c) at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure. The stabilization device is positionable over the fixed segment and the separable driver segment such that the proximal head and the distal head are disposed within the lumen between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure. Device according to claim 1. **Claim 8** A bone fixation device comprising: (a) a fixed segment comprising: (i) an elongated non-cannulated threaded fixation shaft having a diameter of less than about 5 mm; (ii) a sharp distal tip; (iii) a proximal head having a first connection structure and having a proximal flat surface including a diameter greater than the diameter of the elongated fixation shaft. (b) a separable driver segment comprising: (i) an elongated driver shaft having a diameter of less than about 5 mm; (ii) a distal head having a distal flat surface and a second connection structure, the second connection structure being separably connectable to the first connection structure and the distal flat surface being engageable with the proximal flat surface. (c) a stabilization device comprising: (i) an elongated body having a lumen defined therethrough; (ii) at least one distal flexible retaining structure disposed within the lumen; (iii) at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure, a stabilization device comprising, and including, The fixed segment and the separable driver segment are such that the proximal head and the distal head are connected together and are positioned through the lumen of the stabilization device such that they are disposed between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure for transport, storage, and use of the bone fixation device. A bone fixation device.

9. The device according to claim 8, wherein the first connecting structure is a female connecting structure and the second connecting structure is a male connecting structure.

10. The device according to claim 9, wherein the female connecting structure comprises an opening defined in the proximal flat surface of the proximal head, the male connecting structure comprises a ribbed protrusion extending from the distal flat surface, and the male connecting structure is engageable with the opening defined in the proximal flat surface.

11. The device according to claim 8, wherein the sharp distal tip includes a self-tapping tip.

12. The device according to claim 8, wherein the proximal head comprises a distal surface having a curved convex shape and the distal head comprises a proximal surface having a curved convex shape.

13. A method of implanting a fixation device into a target bone, the method comprising: Positioning a combination device at a desired location on the target bone, the combination device comprising: (a) a fixation device comprising an elongated non-cannulated fixation shaft having a diameter of less than about 5 mm and a proximal head having a diameter greater than the diameter of the elongated fixation shaft; and (b) a separable driver device, positioning; Rotating the separable driver device in a first direction using a power driver tool until the proximal head is flush with the outer surface of the target bone to insert the fixation device into the target bone; Separating the separable driver device from the fixation device, a method comprising.

14. The method according to claim 13, wherein the positioning of the combination device and the insertion of the fixation device are performed without using any pre-drilling, tapping, countersinking, measuring, or use of a guide wire.

15. Further comprising providing the combination device before positioning the combination device at the desired position of the target bone, the separable driver device being connected to the fixation device, the method according to claim 13.

16. Further comprising packing, transporting, and / or storing the combination device while the separable driver device is connected to the fixation device, the method according to claim 15.

17. Further comprising reattaching the separable driver device and rotating the separable driver device in a second direction to retract the fixation device by a certain length relative to the target bone, the method according to claim 13.

18. The method according to claim 17, wherein the retraction of the fixation device includes completely retracting the fixation device from the target bone.

19. Further comprising positioning the combination device through a stabilization device before inserting the fixation device into the target bone, the stabilization device being (a) the elongated body having a lumen defined therethrough; (b) at least one distal flexible retention structure disposed within the lumen; (c) at least one proximal flexible retaining structure disposed within the lumen proximal to the at least one distal flexible retaining structure; The method of claim 13, wherein the proximal head and the distal head are connected together and disposed between the at least one distal flexible retaining structure and the at least one proximal flexible retaining structure.

20. The method of claim 19, wherein inserting the fixation device into the target bone further comprises rotating the separable driver device in the first direction until the proximal head exits the stabilization device.

Images