Systems and methods for the fixation or fusion of bone

ES 2 706 005 T3

DESCRIPTION

Bone Fixation / Fusion Device

Related requests

The present application is a partial continuation of the pending United States patent application together with the present serial number 10 / 914,629, filed on August 9, 2004.

Field of the invention

The present application relates, in general, to the fixation of bones.

Background of the invention

Many types of equipment are available, both for the fixation of fractures and for the fixation of bones that have been fused (subjected to an arthrodesis).

Metallic and absorbable screws are commonly used to fix bone fractures and osteotomies. It is important for the successful outcome of the procedure that the screw is capable of generating useful compressive forces to promote bone healing.

WO 03/007839 discloses an orthopedic device that is made of a hardened extracellular matrix material. A device comprises a head portion for engaging soft tissue and a body portion for engaging and attaching to bone.

US 2002/0049497 discloses a spinal implant for joining two adjacent vertebrae. The implant comprises a body having first and second opposing surfaces, each surface including at least one protruding member for attaching the body to the vertebrae.

WO 01/17445 discloses an elongated bone splint for location within a bone socket, for example through a joint. The bone splint comprises a series of barbs formed on its outer surface. The splint may have an axially extending channel to receive a suture or guidewire.

Summary of the invention

In accordance with the present invention, there is provided a bone fixation / fusion device according to claim 1.

The invention provides bone fixation / fusion devices for stabilizing bone segments, which may comprise parts of the same bone (eg, fracture fixation) or two or more individual bones (eg, fusion). The systems include a fixation / fusion device adapted for placement in association with bone segments.

At least a part of the device includes a porous region that allows for internal growth and / or transverse growth of the bone.

In one embodiment, the device includes a first region of essentially non-resorbable material and a second region of essentially resorbable material.

In one embodiment, the device includes a region that engages another bone fixation / fusion device to form a composite device.

In one embodiment, the device includes at least one stabilization element and / or one anti-rotation element.

The bone fixation / fusion device is elongated and includes a triangular cross section. The device may have other cross-sectional geometries in addition to the triangular cross-section, for example, a generally curvilinear (ie, round or oval) cross-section, or a square or rectangular cross-section.

Brief description of the drawings

Figures 1 and 1B are alternate perspective views of a bone fixation / fusion device having an inner growth and / or transverse bone growth region of a mesh configuration. Figure 1A represents a comparative device and Figure 1B represents a device of the invention.

Figure 2 is a perspective view of a comparative embodiment of a fixation / fusion device

ES 2 706 005 T3 bone having an inner growth and / or transverse growth region of bone of a flanged configuration.

Figure 3 is a perspective view of a comparative embodiment of a bone fixation / fusion device having an inner growth and / or transverse growth region of bone of a trabecular configuration.

Figure 4 is a schematic view of a bone fixation / fusion device of the type shown in Figure 1, which is inserted in association with bone through a fracture line or between different bone segments.

Figure 5 is a schematic view of a bone fixation / fusion device positioned in association with a fracture line or between different bone segments with an inner growth and / or transverse growth region of bone extending through the fracture line or a space between different bone segments.

Figure 6 is a front plan view of an alternate example of a bone fixation / fusion device having an inner growth and / or transverse growth region of bone in which the device has a conical configuration.

Figure 7 is a front plan view of an alternate example of a bone fixation / fusion device having an inner growth and / or transverse growth region of bone in which the device has a beveled distal tip.

Figures 8A and 8B are schematic representations illustrating the insertion of a bone fixation / fusion device of the type shown in Figure 6 in association with a fracture line or between different bone segments.

Figure 9 is a schematic representation illustrating a guidewire that is inserted into bone in association with a fracture line or between different bone segments.

Figure 10 is a schematic representation similar to Figure 9 and illustrating a drill bit that is inserted through the guidewire.

Figure 11 is a schematic representation similar to Figure 10 and illustrating a hole formed in the bone remaining after removal of the drill bit.

Figure 12 is a schematic representation similar to Figure 11 and illustrating insertion of a bone fixation / fusion device into the preformed hole.

Figure 13 is an exploded front plan view illustrating engagement of a pair of bone fixation / fusion devices by threaded engagement.

Figure 14 is a schematic representation illustrating a pair of bone fixation / fusion devices coupled to each other and inserted in association with a fracture line or between different bone segments. Figure 15 is a front plan view illustrating passage of a bone fixation / fusion device through a fenestration in another bone fixation / fusion device.

Figure 16 is a schematic representation illustrating the placement of a series of bone fixation / fusion devices in bone.

Figure 17 is a top plan view of a bone fixation / fusion device positioned in association with a fracture line or between different bone segments.

Figure 18A is a perspective view of an alternate example of a bone fixation / fusion device having an inner growth and / or transverse growth region of bone that extends substantially the entire length of the device.

Figure 18B is a perspective view of a bone fixation / fusion device similar to Figure 18A and having an inner growth and / or transverse growth region of bone extending along a portion of the device.

Figure 19 is a top plan view of the bone fixation / fusion device of Figure 18A positioned in association with a fracture line or between different bone segments.

Figure 20 is a top plan view of the bone fixation / fusion device of Figure 18A positioned in association with a fracture line or between different bone segments and stabilized by fixation screws.

Figures 21A through 21F are perspective views illustrating alternative configurations of bone fixation / fusion devices of a type shown in Figure 18A.

Figures 22A and 22B are perspective views illustrating alternative examples of the bone fixation / fusion device of a type shown in Figure 18A in which the device is outlined.

Figures 23A and 23B are perspective views illustrating alternative examples of the bone fixation / fusion device of a type shown in Figure 1 with structural elements that provide an anti-rotational function.

Figure 24 is a perspective view illustrating an alternate example of the bone fixation / fusion device of a type shown in Figure 18A, in which the device includes a series of grooves that provide an anti-rotational function.

Figure 25 is a perspective view illustrating an alternate example of the bone fixation / fusion device of a type shown in Figure 18A in which the device includes a pair of opposing wings that provide an anti-rotational function.

Figure 26 is a perspective view illustrating an alternate example of the bone fixation / fusion device of Figure 18A in which the device includes a pair of opposing flanges that provide an anti-rotational function.

ES 2 706 005 T3

Figure 27 is an exploded view of a pair of coupled bone fixation / fusion devices which, when secured together, form a composite bone fixation / fusion device.

Figure 28 is an assembled view of the composite bone fixation / fusion device formed from the assembly of the bone fixation / fusion devices shown in Figure 27.

Figure 29 is a front view of the assembled composite bone fixation / fusion device of Figure 28 positioned in association with a fracture line or between different bone segments.

Figure 30 is a perspective view of an alternate example of the bone fixation / fusion device of a type shown in Figure 18A with fixation plates.

Figure 31 is a perspective view of an alternate example of the bone fixation / fusion device of Figure 30.

Figure 32 is a side view of an alternate example of a clamp plate having a rounded configuration.

Figure 33 is a side view of an alternate example of a clamp plate having a tapered configuration.

FIG. 34 is a perspective view of an alternate example of the bone fixation / fusion device of a type shown in FIG. 18A that provides a series of radially extending fixation ridges.

Figures 35A and 35B are perspective views of a bone fixation / fusion device having a malleable region that can be widened or expanded to provide fixation and / or anti-rotation resistance.

Figure 36 is a front plan view illustrating the drilling of pilot holes in adjacent bone segments, which may comprise a fracture line in the same bone or different bone segments. Figure 37 is a front plan view illustrating a cavity drilled between the pilot holes to receive a bone fixation / fusion device.

Figure 38 is a front plan view illustrating the placement of a pair of guide pins within the perforated cavity.

Figure 39 is a front plan view illustrating placement of the bone fixation / fusion device in the socket and removal of the guide pins.

Figure 40 is a front plan view illustrating the placement of a pair of opposing C-shaped restraints within the perforated cavity.

Figure 41 is a front plan view illustrating the placement of the bone fixation / fusion device in the socket within the restraints.

Description of the preferred embodiment

Although the disclosure herein is detailed and accurate to enable those skilled in the art to practice the invention, the physical embodiments disclosed herein merely exemplify the invention that can be made in another specific structure. Although the preferred embodiment has been described, the details can be changed without departing from the invention, which is defined in the claims.

Figures 1A and 1B show representative alternative configurations of a device 10 sized and configured for fixation of bone fractures (i.e., fixation of parts of the same bone) or for fixation of bones to be fused (subjected to arthrodesis) ( that is, the fixation of two or more individual bones that are adjacent and / or joined). For the sake of brevity, the device will sometimes be referred to as a bone fixation / fusion device, to indicate that it can perform a fixation function between two or more individual bones, or a fusion function between two or more parts of the same bone, or both functions. As used herein, "bone segments" or "adjacent bone regions" refer to either situation, ie, a fracture line in a single bone or a space between different bone segments.

In the example shown in Figure 1A and one embodiment of the invention as shown in Figure 1B, the bone fixation / fusion device 10 comprises an elongated stem-like structure. Device 10 may be formed, for example, by machining, molding, or extrusion, from a material useful in prosthetic techniques, including, but not limited to, titanium, titanium alloys, tantalum, cobalt chrome, surgical steel, or any other full bond replacement metal.

The bone fixation / fusion device 10 of the invention includes a triangular cross section, as shown in Figure 1B for purposes of illustration. The device may have other cross-sectional geometries in addition to the triangular cross-section, for example, a generally curvilinear (ie, round or oval) cross-section, or a square or rectangular cross-section.

As Figures 2 and 3 show, bone fixation / fusion device 10 desirably includes a region 12 formed along at least a portion of its length to stimulate bone ingrowth on or on the surface of device 10 and / or the complete growth of the bone through all or part of the device 10.

Region 12 may comprise, for example, through holes, and / or various surface patterns, and / or various surface textures, and / or pores, or combinations thereof. Device 10 may be coated or wrapped or

ES 2 706 005 T3 be surface treated to provide the Inner growth and / or transverse growth region of bone 12, or may be formed from a material that inherently possesses a structure conducive to inner growth or transverse growth of bone, such as a porous mesh, hydroxyapatite, or other porous surface. Device 10 may be further coated with other different coatings, such as antimicrobial, antithrombotic, and osteoinductive agents, or a combination thereof. Region 12 can be impregnated with such agents, if desired.

Of course, the configuration of region 12 may vary. By way of example, Figure 1 shows region 12 as an open mesh configuration; Figure 2 shows region 12 as a flanged configuration; and Figure 3 shows region 12 as a trabecular configuration. Any configuration conducive to ingrowth or transverse growth of the bone will suffice.

During use (see Figures 4 and 5), the bone fixation / fusion device 10 is inserted into a space between two adjacent bone surfaces, for example, at a fracture site in a single bone or between two bones (e.g. for example, adjacent vertebral bodies) that must be fused together. In Figure 4, device 10 is shown drilling bone through bone segments 14 (i.e., through a fracture line or between adjacent bones to be fused) with a drilling tool 16. The bone can be drilled first to facilitate insertion of the device 10. The bone ingrowth and / or transverse growth region 12 along the surface of device 10 accelerates the ingrowth or transverse growth of bone on, in, or through the device 10. The ingrowth or transverse growth of the Bone on, in, or through device 10 helps speed up the fusion process or the time to heal the fracture.

The bone inner growth and / or transverse growth region 12 may extend along the entire outer surface of the device 10, as shown in Figure 4, or the bone inner growth and / or transverse growth region 12 may cover only a specified distance on each side of the bone segments or the fracture line, as shown in figure 5.

The size and configuration of device 10 can be varied to suit the type and location of the bone to be treated, as well as the individual anatomy.

As Figure 6 shows, device 10 may be angled or tapered in a conical configuration. The degree of angle can be varied to suit specific needs or individual anatomy. A smaller degree of angle (ie, a more acute angle) decreases the risk of splitting the bone when the device 10 pierces the bone or the fracture segments 14. Device 10 may also include a beveled distal tip 18 to be further added upon insertion of device 10 into bone, as shown in Figure 7. As shown in Figures 8A and 8B, the tapered shape also helps drive the bone segments or fracture fragments together, reducing the gap (G) between the bone segments 14 or the fracture segments.

In Figures 9 through 12, device 10 is cannulated, having a central lumen or through hole 20 extending therethrough, to aid in placement of device 10 within bone. Figure 1B also shows a cannulated through hole 20 in a different configuration.

During use, the clinician may insert a conventional guide pin 22 through bone segments 14 by conventional methods, as shown in Figure 9. A cannulated drill bit 24 can then be inserted through guide pin 22, as shown. see Figure 10. A single drill bit or multiple bits 24 may be used to drill bone fragments or bone surfaces to create a hole 26 of the desired size and configuration. In the illustrated example, drill bit 24 is sized and configured to create a tapered hole 26 similar in size and configuration to device 10. Hole 26 is desirably sized and configured to allow firm engagement of device 10 within hole 26 and thereby restricting movement of device 10 within hole 26. Preformed hole 26 may be slightly smaller than device 10, while still allowing device 10 to be held in position within hole 26 by piercing. As seen in Figure 11, the bit 24 is then removed. Device 10 is then inserted into hole 26 through guide pin 22, as shown in Figure 12. Guide pin 22 is then removed.

Alternatively, the bone fusion / fixation device 10 itself may include screw threads throughout the body to screw the device into place. In the arrangement, the device 10 may be self-sustaining. Also in this arrangement, device 10 can be cannulated for use with a guide pin 22, or does not need to be cannulated.

Multiple devices 10 may be employed to provide additional stabilization. Although the use of multiple devices 10 will be described below illustrating the use of multiple devices 10 of the same size and configuration, it is contemplated that devices 10 may also be of different size and / or configuration, for example, a device 10 is of a cylindrical configuration and a second device 10 is of a conical configuration.

ES 2 706 005 T3

In many cases, it may be desirable to couple a number of devices 10 together, for example, to provide stabilization over a larger surface area. A series of devices 10 may be coupled to one another by any suitable means, for example, by a snap fit coupling, or a reed pin and slot arrangement, or by a Morse taper fit, or combinations thereof. In one example, a series of devices 10 are coupled by threaded engagement. As illustrated in Figure 13, a first device 10A includes a recess 28 at one end that provides a series of internal threads 30. In the illustrated example, the first device 10 is of a cylindrical configuration, but can be of any configuration. desired. The internal threads 30 mate with a series of complementary external threads 32 on a second device 10B of a similar or different configuration to couple the first and second devices 10A and 10B together.

Devices 10A and 10B are desirably coupled together prior to being inserted into preformed hole 26. The series of internal and external threads 30 and 32 provide an interlocking mechanism that allows a series of devices 10 to be stacked and connected to cover a larger area or multiple bone segments 14 (for example, a bone that has multiple fractures) and thus provides additional stabilization, as seen in Figure 14.

Figure 15 illustrates another example where a device 10 'includes an opening or fenestration 34 to allow another device 10 to pass through, thereby providing additional stabilization. Fenestration 34 can be sized and configured to allow another device 10 to pass through device 10 'at virtually any angle. The fenestration 34 can also be sized and configured to limit movement of the second device 10 relative to the second device 10 '.

During use, and as shown in FIG. 16, the physician pierces a first device 10 'having a fenestration 34 through the bone segments. Next, a second device 10 is inserted (eg, by piercing) through the fenestration 34 of the first device 10 'in its place.

It is further contemplated that device 10 'may also be adapted to mate with another device 10A (for example, via a series of internal and external threads), allowing devices 10' and 10A to be further stacked and connected, as also shown in figure 16.

Figure 17 illustrates an alternative form of a bone fixation / fusion device 100. Similar to the type of bone fixation / fusion device 10 described above, the device 100 includes a body 106 formed of a durable material that is not subjected to significant bioabsorption or resorption by surrounding bone or tissue over time. In other words, the body 106 is intended to remain in place long enough to stabilize the fracture or fusion site. Such materials are well known in the prosthetic arts and include, for example, titanium, titanium alloys, tantalum, cobalt chromium, surgical steel or any other fully bonded replacement metal and / or ceramic, sintered glass, artificial bone, any surface. uncemented metal or ceramic, or a combination thereof. Alternatively, the body 106 of the bone fixation / fusion device 100 may be formed from a suitable durable biological material or a combination of metallic and biological material, such as a biocompatible bone filler material. The body 106 of the device 100 can be molded both with a fluid biological material, for example acrylic bone cement, which is cured, for example, by UV light, and with a non-fluid or solid material.

Body 106 of device 100 may also include an inner growth and / or transverse growth region of bone 108, as already described in conjunction with previous examples.

Unlike bone fixation / fusion device 10, bone fixation / fusion device 100 includes at least one region associated with body 106 that, in contrast to body 106, comprises a material that is bioabsorbed or bioabsorbed. faster in vivo resorption by surrounding bone or tissue over time, eg, over weeks or a few months. The resorbable material may comprise, for example, polylactic acid (PLA), polyglycolic acid (PGA), poly (lactidaglycolide) copolymers, polyanhydrides, cyclode, cirsns, polyorthoesters, n-vinyl alcohol or other known or recognized bioabsorbable polymers or similar materials. in prosthetic techniques that have such characteristics. The bioabsorbable region is intended to facilitate implantation or positioning of the body 106, but will over time be absorbed to minimize the footprint of the implanted device 100 in the long term.

The bioabsorbable region or regions may possess functionality to aid in the implantation process. For example, as shown in the illustrated example, there are two bioabsorbable regions 102 and 104. Region 102 comprises a bioabsorbable screw region 102, which is desirably threaded or otherwise suitably configured to pierce bone and facilitate advancement. of device 100 in the bone. The other region 104 comprises a bioabsorbable head region 104, which is desirably configured to engage an installation instrument, eg, a screwdriver, to further facilitate advancement and placement of the bone fixation / fusion device 100. on the bone. Bioabsorbable head 104 may also be sized and configured to temporarily anchor device 100 within bone, for example, head 104 may have a slightly larger diameter than body 106 of device 100. The screw portion

ES 2 706 005 T3 bioabsorbable 102 and head portion 104 are configured to provide immediate benefit during initial placement of device 100, but may be resorbed over time when they have served their initial purpose during implantation. This leaves the more durable and less resorbable body 106 behind to fulfill its long-term function of stabilizing the fracture or fusion site.

As disclosed above, a given bone fixation / fusion device can take various shapes and geometries. For example, as shown in Figures 18A and 18B, bone fixation / fusion device 200 has a flattened rectangular (or wafer-like) configuration. A region 12 of device 200 may be textured or treated, as described above, to provide an ingrowth or transverse growth of bone. The bone growth and / or transverse growth region 12 may extend throughout the entire device 200 (see FIG. 18A) or along any portion or portions of the device 200 (see FIG. 18B).

The bone fixation / fusion device 200 is desirably sized and configured to be positioned to join two or more adjacent bone segments 14 (which may comprise a fracture site, a fusion site, or both), as shown in the figure. 19, to fix and stimulate fusion of the adjacent bone segments 14. Device 200 may also be sized and configured to fix and stimulate fusion of multiple bone segments 14 or compound fractures, as shown in Figure 20. Figure 20 illustrates placement of bone fixation / fusion device 200 sized and configured for fixation and fusion of, for example, a first wedge (CE1), a second wedge (CE2), a first metatarsal (M1) and a second metatarsal (M2).

As shown in Figure 20, one or more auxiliary fixation elements, such as conventional orthopedic screws 206, may also be placed into and / or through the bone segments 14 by conventional techniques, to increase stabilization of the bone segments. 14 during the fusion process.

The size and configuration of the bone fixation / fusion device 200 can be modified or adjusted in various ways to fulfill the intended stabilization function in various bone locations, bone geometries, or types of bone, which are intended to be fused or repaired. The bone fixation / fusion device 200 may come in a family of different preset sizes and shapes, or it may be individually sized and configured to meet the requirements of a specific individual's anatomy. For illustrative, but not limiting purposes, a particular bone fixation / fusion device 200 may take the form of a disk (FIG. 21A), a square (FIG. 21B), or an oval (FIG. 21C). The height, width and length of a particular bone fixation / fusion device 200 can vary depending on the specific location and amount of bone to be traversed for stabilization. A given bone fixation / fusion device can have a symmetric geometry, or an asymmetric or complex geometry, such as an L-shape (Figure 21D), a triangle (Figure 21E), or a rectangle with triangular ends (Figure 22F) . Any combination of linear or curvilinear or rounded geometries is possible.

As described above, a particular bone fixation / fusion device can be cannulated to aid in orientation during placement or implantation. For example, as shown in Figures 18A and 18B, device 200 may include a pair of opposing guide holes 202. Guide holes 202 are sized and configured to accommodate the passage of guide pins 204, which are clamped at the intended placement site of the device. Other forms of cannulated devices 200 are shown in Figures 21B and 24. In this manner, bone fixation / fusion device 200 can be guided by pins 204 to the intended bone placement site.

The device can be profiled to aid in the stabilization of a particular bone fixation / fusion device within the bone. For example, as shown in FIG. 22A, bone fixation / fusion device 200 may vary in height over the entire length of device 200, to form a tapered wedge. Alternatively, as shown in FIG. 22B, bone fixation / fusion device 200 may vary in height only at one end. In these arrangements, the bone fixation / fusion device 200 is desirably positioned with the area of ​​greatest height in the proximal direction, which serves to wedge the device 200 into place within the bone.

Also to aid in the stabilization of a particular bone fixation / fusion device within the bone, the device may include one or more anti-rotation elements, which further stabilize and hold the device in the desired position within the bone. The size and configuration of the anti-rotation elements may vary. For example, the anti-rotation elements may comprise a set of fins 300 protruding from a stem-like device 10 (Figure 23A), or a set of slits 302 formed in a rectangular wafer device 200 (Figure 24), or wings 304 formed into a rectangular wafer device 200 (Figure 25), or flanges 306 protruding from a wafer device 200 (Figure 26). The antirotation elements may comprise (see FIG. 23B) a set of protrusions 308 or surface protrusions 310 formed in all or part of the device, which may be rod-shaped or wafer-shaped in configuration. Any number of antirotation elements, or any configuration of antirotation elements, or any combination of configurations can be provided to meet the functional objective of stabilization.

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As also described above, two or more bone fixation / fusion devices 200 of the types generally described above can be assembled to form a composite bone fixation / fusion device having a desired size and configuration. For example, in the arrangement shown in Figures 27 to 29, the bodies of two bone fixation / fusion devices 200 each have a slot 208. Slot 208 in a first device 200 mates with a similar or complementary slot 208 in a second device 200 to allow assembly of a composite bone fixation / fusion device 310, which has a cross anti-rotational configuration for placement through the bone segments 14. The cross-relationship of the composite bone fixation / fusion device 310 has an increased surface area and adds additional stability to the devices 200 in the bone during the fusion process.

It will be apparent to those skilled in the art that the location, size, and configuration of the grooves 208 can be varied to suit specific needs and a specific anatomical location, as well as individual anatomy. It is also apparent that other coupling configurations, for example tongue and groove fittings, or push-fit arrangements, or Morse taper fits, or threaded assemblies, may be used to assemble two or more bone fixation / fusion devices into a composite device 310.

As shown in FIG. 30, fixation or grip plates 212 can be fitted to a given bone fixation / fusion device. In the arrangement shown in FIG. 30, the body of the bone fixation / fusion device 200 includes one or more attachment sites 210, eg, slits or recesses, that are sized and configured to receive a fixation or grip plate selectively. removable 212. When received within slit 210, plate 212 extends radially from the device to grip the bone and further clamp the device 200 within the bone.

In an alternate example, shown in Figure 31, attachment site 210 may include a tab 214, which engages a notch 216 in clamp plate 212 to secure plate 212 within device 200.

Other forms of interlocking or nesting configuration can be used. For example, tongue and groove fittings, or press fit arrangements, or threaded fittings or Morse taper assemblies can be used to assemble one or more fixation or grip plates to a bone fixation / fusion device.

The fixation or grip plate 212 is formed of durable biocompatible metal or bone replacement material, as described above. In some cases, it may be desirable to provide a bone ingrowth surface on at least a portion of plate 212. Alternatively, plate 212 may be formed of a bioabsorbable material, as already described.

Figures 30 and 31 illustrate examples where plates 212 are generally blunt and flat in configuration. It will be apparent to those skilled in the art that, however, the plates 212 may also provide a sharp or cutting edge or otherwise be sized and configured as necessary to suit a specific location and individual anatomy. For example, plate 212 can be rounded (Figure 32) or tapered (Figure 33).

Figure 34 illustrates an alternate example in which one or more fixation ribs 218 extend radially from bone fixation / fusion device 200. Similar to fixation plates 212, ribs 218 can be dimensioned and configured in a variety of ways. ways in order to grip the bone and further secure the bone fixation / fusion device 200 within the bone.

The fasteners can be formed in situ. For example, as shown in FIG. 35A, a bone fixation / fusion device 200 may include a malleable region 320 that typically exhibits a low profile conducive to implantation. As shown in Figure 35B, the profile of the malleable region 320 can be changed in situ after implantation to a radially expanded or extended profile 326 that provides stabilization or an anti-rotational function to the device 200. In the illustrated embodiment, the malleable region 320 is slotted (see FIG. 35A) to allow placement of a wedge tool 324 carried for manipulation by a stylet or cannula 322 (see FIG. 35B). Wedge tool 324 skinns grooved malleable region 320 (as shown in FIG. 35B), to create expanded profile 326 for stabilization and / or resistance to rotation.

In use, and referring to Figure 36, pilot holes 220 are drilled into adjacent bone segments 14 (eg, along a fracture line in a single bone or between adjacent segments of different bones) by conventional surgical techniques. In the illustrated example, a single pilot hole 220 is drilled in each bone segment 14. It should be understood that the number and configuration of pilot holes 220 can vary as needed or desired.

As shown in FIG. 37, the clinician can then saw, using conventional methods, between pilot holes 220 to prepare a cavity 222 to receive device 200.

Guide pins 204, if desired, can be positioned at opposite ends of perforated cavity 222, as seen in Figure 38. In this arrangement, as shown in Figure 39, the fixation / fusion device of

ES 2 706 005 T3 Selected Bones 200 is passed through guide pins 204 to position device 200 with socket 222. Guide pins 204 can then be removed. In an alternative arrangement, it is not necessary to use the pins guide 204, and the physician manually inserts device 200 into perforated cavity 222.

An alternate example is illustrated in Figures 40 and 41. In this example, a c-shaped restraint 224 is placed against each end of the perforated socket 222. Next, the selected bone fixation / fusion device 200 is placed between restraints 222 such that restraints 222 engage device 200 to hold device 200 within the bone.

The foregoing is only considered as illustrative of the principles of the invention. Furthermore, since numerous modifications and changes will occur to those skilled in the art, it is not intended to limit the invention to the exact construction and operation shown and described. Although the preferred embodiment has been described, the details can be changed without departing from the invention, which is defined in the claims.