Patent ID: 12256949

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

In this application, the words proximal, distal, anterior or plantar, posterior or dorsal, medial and lateral are defined by their standard usage for indicating a particular part or portion of a bone or prosthesis coupled thereto, or directional terms of reference, according to the relative disposition of the natural bone. For example, “proximal” means the portion of a bone or prosthesis nearest the torso, while “distal” indicates the portion of the bone or prosthesis farthest from the torso. As an example of directional usage of the terms, “anterior” refers to a direction towards the front side of the body, “posterior” refers to a direction towards the back side of the body, “medial” refers to a direction towards the midline of the body and “lateral” refers to a direction towards the sides or away from the midline of the body. Further, specifically in regards to the foot, the term “dorsal” refers to the top of the foot and the term “plantar” refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current devices, instrumentation and methods are described herein with reference to use with the bones of the foot, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the devices, instrumentation and methods. Further, the devices, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the devices, instrumentation and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the invention. For example, the devices, instrumentation and methods, and the aspects, components, features and the like thereof, described herein with respect to the right foot may be mirrored so that they likewise function with the left foot. Further, the devices, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the foot for brevity purposes, but it should be understood that the devices, instrumentation, and methods may be used with other bones of the body having similar structures, for example the upper extremity, and more specifically, with the bones of the wrist, hand, and arm.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference toFIGS.1-2, there is illustrated an exemplary embodiment fixation guide device100. The fixation guide device100includes an outrigger assembly or frame102which may be coupled to a compression device140and an intramedullary nail200. In the embodiment depicted inFIGS.3-4, the outrigger assembly102includes a base104with a first drill hole106, a second drill hole108, a third drill hole110, a second or lateral arm114with a fourth drill hole112, and a first or distal arm116. It is also contemplated that the frame102may include, for example, a plurality of drill holes106,108,110,112as necessary to secure the intramedullary nail200across a joint or fracture. The drill holes106,108,110,112may each include, for example, multiple holes spaced a small distance apart or multiple nested or overlapping holes to correspond to the openings208,210,212,214in multiple size intramedullary nails200. The frame102may include a first end and a second end. The base104may include at least one opening120allowing for visualization through the base104with imaging technology, such as x-rays, and a bracket122, as seen inFIG.3, for stabilization of the fixation guide device100where the opening120is large. The bracket122may provide stability to the base104allowing for alignment of the fasteners for insertion in the nail200. The distal arm116is perpendicular to the base104at the distal end and includes a knob opening or first opening124, a nail attachment opening or second opening126, and a nail attachment portion or apparatus128. The nail attachment portion128includes an end with an inverted two step profile including a first step or first nail attachment segment180extending a first distance and a second step or second nail attachment segment182extending a second distance. The first distance is greater than the second distance. The base104is ideally made of a material that is strong enough to prevent deformation during surgery, such as a metal, while also being radiolucent to allow for imaging through the base104to determine if correct alignment of the nail200was achieved. The base104may be made of, for example, carbon fiber.

The compression device140slidingly mates with the nail attachment portion128. The compression device140includes a compression member142, a knob144, and a bolt146. As best seen inFIGS.5-6, the compression member142has a base158with a top end148and a bottom end150. The compression member142also includes a protrusion160at the bottom end150. A first opening152is near the top end148for receiving bolt146. The first opening152is threaded to mate with a threaded end156of bolt146. A second opening154is near the bottom end150and passes through the base158and protrusion160. The second opening154is slidingly engaged with the nail attachment portion128. The proximal end of the compression member142is angled from a point between the top and midline of the protrusion160to approximately a midpoint162of the bottom end150of the base158of the compression member142. The angled portion of the protrusion160may include teeth164for engaging a patient's bone.

As depicted, after the compression member142is slid over nail attachment portion128, the knob144may be secured to the base104using a bolt146and a fastener (not shown). The knob144is shown inFIG.7and bolt146is illustrated inFIG.8. The threaded end156of bolt146is inserted into knob opening124and the threaded end156mates with the threads of the second opening154. The bolt146also includes a stop member166and a smooth end168. The stop member166prevents bolt146from passing through knob opening124. The smooth end168of bolt146may be inserted into an opening176in the knob144. The bolt146and knob144are locked in place with a fastener (not shown), such as a pin, clip, or the like, inserted through opening170of the knob144and bolt opening or opening172. Opening170is generally perpendicular to opening176and passes through the entire knob144. The knob144may also include ridges178on an exterior surface to aide in the rotation of the knob144by the surgeon.

Referring now toFIGS.9-10with continued reference toFIGS.1-2, the intramedullary nail200includes a body202with a closed end204, a fastening end206, and four openings208,210,212,214. The four openings208,210,212,214may be disposed on independent planes and angularly spaced apart relative to each other. By placing the four openings208,210,212,214at opposing angles oblique to the longitudinal axis of the nail200, the amount of longitudinal and rotational movement of the nail200is limited. It is also contemplated that the intramedullary nail200may include any number of openings208,210,212,214as may be necessary to secure the nail to a patient's bones. The fastening end206includes an insertion opening216and an engagement opening218. The insertion opening216is a threaded opening along a longitudinal axis in the center of the nail200parallel to the exterior surface of the nail200. The insertion opening216is used to secure the nail200to the nail attachment portion128using an engagement fastener220, such as a screw. The engagement opening218may include a central axis that is generally transverse the longitudinal axis of the nail200. As illustrated inFIG.11, the engagement fastener220includes a head222with a drive opening224and a shank226that is partially threaded including a smooth portion228and a threaded portion230. The drive opening224may be, for example, hexagonal, square, Phillips or another multi-lobed configuration for coupling with an insertion instrument. The engagement fastener220is inserted through opening126and passes through the nail attachment portion128before being screwed into the insertion opening216to secure nail200to the nail attachment portion128.

The engagement opening218of the nail200may be a threaded opening that passes through the exterior surface of nail200to secure the nail200to the bone using a fastener, such as a locking screw232. The locking screw232is depicted inFIG.12and includes a head234with a drive opening236and a shank238with a first threaded section240, a smooth section242, and a second threaded section244. The drive opening236may be, for example, a Phillips opening, a flat head opening, a hexagonal opening, or other multi-lobed configuration. The second threaded section244is designed to engage the patient's bone. The first threaded section240of the locking screw232is threaded to correspond to the threads246of the engagement opening218to secure the nail200in place inside the patient's bones. The first threaded section240may have a larger diameter than the second threaded section244allowing for the second threaded section244to pass through the opening218without engaging the threads246. Alternatively, the first threaded section240and second threaded section244may have the same diameters such that the second threaded section244would mate with the threads246as it passes through the opening218. For example, the threads of the first threaded section240and second threaded section244may have the same pitch to allow both the first threaded section240and second threaded section244to mate with opening218. In order to provide for thread differentiation between the first threaded section240and second threaded section244the second threaded section244may have a single lead thread and the first threaded section240may include a double lead thread in order to improve bone purchase.

The nail200may also include a fastening end206with a shape that corresponds to the shape of the end of the nail attachment portion128to create a tight fit between the nail200and the attachment portion128. As depicted inFIGS.9-10, the fastening end206may have a two step profile including a first step or first fastening segment248and a second step or second fastening segment250. When the nail200is secured to the outrigger assembly102the first fastening segment248aligns with second nail attachment segment182and second fastening segment250aligns with first nail attachment segment180. The engagement fastener220may then be inserted to secure the nail200to the outrigger assembly102. The step profiles of the nail200and the nail attachment portion128provide additional stability to the nail200during insertion into the patient's bone and prevent nail200from rotating during insertion of the pegs and screws.

The surgical method for inserting the intramedullary nail200into a patient's joint260may include the steps ofFIG.55, as illustrated inFIGS.13-32. The method utilizes some of the devices, instruments, features, aspects, components, and the like described above, and therefore reference will be made to the above described embodiments, such as the illustrated embodiments presented in the figures and discussed above. However, such references are made for exemplary purposes only and are not intended to limit the surgical method beyond the specifically recited steps. Further, the surgical method may be discussed under the umbrella of particular bones, but such an application is not intended to be limiting and the method described herein may be used or conducted with bone or other tissue not specifically discussed herein without departing from the spirit and scope of the surgical method.

If a joint260, for example, a proximal tarsal-metatarsal joint or the like, needs to be surgically fixed, a surgeon would first expose the joint260by creating an incision over the joint260shown in step352. Next, in step354, the first bone262and second bone264of the joint260will be prepared by using a cut guide and cartilage removal technique such as curet, osteotome, saw blade, or other similar cartilage removal technique known by one skilled in the art. The joint260is then aligned by moving the first bone262and second bone264into a desired position for fixation. Once the bones262,264are aligned, temporary fixation may be applied to hold the joint260in the desired position. A guidewire, template, or similar clamp may be used to temporarily fix the joint260.

Next, in step356, as seen inFIG.13, a guidewire alignment guide270is positioned onto the first bone262with the first end272of the alignment guide270aligned with the proximal end, for example, the dorsal ridge, of the first bone262at the joint260to align the guide270. The alignment guide270, shown inFIG.14, may include a first opening282on the proximal end of the guide270, a second opening284on the lateral side of the guide270, and a third opening286on the front of the distal end of the guide270. As seen inFIG.14, the guidewire alignment guide270may also include a rim266at the first end272that mates with the edge of the first bone262to hold the alignment guide270in place. In addition, the alignment guide270may include teeth268for mating with the first bone262to maintain a desired position while inserting the guidewires276. A handle274may add additional stability to hold the alignment guide270in position while guidewires276,278,280are inserted into the bone. The guidewires276,278,280may be, for example, K-wires.

Referring now toFIG.15, the first guidewire276may then be inserted through first opening282and into the proximal end of the first bone262. The guide270may be rotated about the first guidewire276if necessary for proper alignment. The second guidewire278may be inserted through second opening284and into the medial side of the first bone262. The third guidewire280may be inserted through the third opening286and across the joint260. The third guidewire280may be positioned to be used as a drilling guide for the intramedullary nail200. Once the third guidewire280is inserted across the joint260the first guidewire276, second guidewire278, and guidewire alignment guide270may be removed, leaving the third guidewire280in position for drilling a cavity for the nail200, as illustrated inFIG.16.

A depth gauge (not shown) may then be used to measure the length of the guidewire280inserted into the bones262,264to determine the length of intramedullary nail200needed. Once the length of the guidewire280that is inserted into the bones262,264is determined three millimeters is subtracted from the measured length to account for compression of the joint260. After subtracting three millimeters, the length of the intramedullary nail200that should be used is known. Next, in step258, a drill may be used to drill over the guidewire280to create a cavity288for the intramedullary nail200. The diameter of the drill used should correspond to the size of the intramedullary nail200that was selected for insertion into the joint260. The drill may include measurement gradients lasered onto the drill bit to allow for reading of the depth drilled. Once the desired depth is reached to fit the selected intramedullary nail200, the drill and guidewire280may be removed leaving cavity288for insertion of the intramedullary nail200, as illustrated inFIG.17.

Next, in step360, a fixation guide device100may be selected. Then in step362, the nail200may be loaded onto the outrigger assembly102of the fixation guide device100by aligning the first step180and second step182of the nail attachment portion128with the second step250and the first step248of the nail200, respectively. Once the nail attachment portion128and nail200are aligned, an engagement fastener220may be inserted into opening126to secure the nail200to the outrigger assembly102creating the fixation guide device100for use during insertion and fixation of the nail200into the cavity288, as depicted inFIGS.1and2. Referring now toFIG.18, the fixation guide device100is then oriented to allow the surgeon to insert the nail200into the pre-drilled cavity288. The nail200is advanced in the cavity288until a positive stop is reached on the guide device100. When the nail200reaches the positive stop it will be countersunk in the cavity288approximately three millimeters (3 mm) preventing prominence of the nail200after compression has occurred and the nail200is in its final position.

Next, in step366, as shown inFIG.19, a drill sleeve290may be inserted into the first drill hole106. The drill sleeve290including a sleeve portion292with a stop member294at the top and an opening296through the center of the sleeve portion292, as depicted inFIG.20. The opening296may have a diameter the size of the drill bit used to drill a cavity298in the second bone264. The drill bit passes through the first opening208in the nail200when the cavity298is drilled. After the cavity298is drilled a depth gauge may be inserted into the cavity298through drill sleeve290to measure the depth of the cavity298. Then the depth gauge and drill sleeve290may be removed from the first drill hole106. Using the measured depth the surgeon may select a first peg300having the desired length. The first peg300may then be inserted through the first drill hole106and into the cavity298, as shown inFIG.22. The first peg300may be inserted relatively perpendicular to the nail200. Referring now toFIG.21, the pegs or fasteners300,320,330, and340include a shaft302with a proximal end and a distal end. The proximal end includes a head304, an upper threaded section306, and a notch308. In the depicted embodiment the head304is a hexagonal head although other head shapes, such as, a flat head, Phillips head, and the like are also contemplated. The distal end includes a lower threaded section310with a pointed end312and a notch314. Between the proximal end and the distal end of the shaft302there may be a smooth region which mates with the first opening208of the nail200. The upper threaded section306of the pegs300,320,330, and340may be substantially flush with the exterior surface of the bones262,264. Alternatively, the pegs300,320,330, and340may be countersunk below the surface of the bones262,264.

In step368, the first peg300may then be used as a counter force for compression as knob144is turned forcing compression member142to move proximally and exert force on the first bone262as the first peg300holds the second bone264in place. As the compression member142is moved the first bone262and second bone264may be compressed at joint260. Once the desired compression is achieved, next in step370, a second peg320may be inserted by inserting the drill sleeve290into a second drill hole108and drilling a second cavity322into the first bone262, as illustrated inFIG.23. The second cavity322will pass through second opening210in the nail200. After the second cavity322is drilled a depth gauge may be inserted into the second cavity322through drill sleeve290to measure the depth of the second cavity322. Then the depth gauge and drill sleeve290may be removed from the second drill hole108. Using the measured depth the surgeon selects a second peg320having the desired length. The second peg320may then be inserted through the second drill hole108and into the second cavity322, as shown inFIG.24. The second peg320may be inserted relatively perpendicular to the nail200. The insertion of the second peg320will secure the achieved compression to prevent the loss of compression.

Referring now toFIG.25, a drill sleeve290may be inserted into the third drill hole110. A drill may then be inserted into opening296in drill sleeve290to drill a third cavity332into the second bone264, as illustrated inFIG.26. The third cavity332passes through the third opening212in the nail200. After the third cavity332is drilled a depth gauge may be inserted into the third cavity332through drill sleeve290to measure the depth of the third cavity332. Then the depth gauge and drill sleeve290may be removed from the third drill hole110. Using the measured depth the surgeon may select a third peg330with the desired length. The third peg330may then be inserted through the third drill hole110and into third cavity332, as shown inFIG.27. The third peg330may be inserted relatively perpendicular to the nail200. The insertion of the third peg330may add additional stability to the compression of the first bone262and second bone264.

A drill sleeve290may be inserted into the fourth drill hole112, as illustrated inFIG.28. A drill may then be inserted into the opening296in the drill sleeve290to drill a fourth cavity342into the first bone262. The fourth cavity342, as best seen inFIG.29, passes through the fourth opening214in the nail200. After the fourth cavity342is drilled a depth gauge may be inserted into the fourth cavity342through drill sleeve290to measure the depth of the fourth cavity342. Then the depth gauge and drill sleeve290may be removed from the fourth drill hole112. Using the measured depth the surgeon may select a fourth peg340with the desire length. The fourth peg340may then be inserted through the fourth drill hole112and into the fourth cavity342, as illustrated inFIG.30. The fourth peg340may be inserted relatively perpendicular to the nail200. The insertion of the fourth peg340may provide additional stability to the compression of the first bone262and the second bone264.

Next, in step372, as shown inFIG.31, after the four pegs300,320,330,340are inserted into the first and second bones262,264, respectively, the outrigger assembly102may be detached from the nail200and removed from the foot. Next, in step374, a locking drill guide may be threaded for inserting the locking screw232into the first bone262through the opening of the intramedullary nail200. Once the locking drill guide is secured, a drill may be passed through an opening in the locking drill guide and the engagement opening218to create a cavity350for the locking screw232. After the cavity350is drilled the locking drill guide may be removed. A depth gauge may then be inserted into the cavity350to measure the depth of the cavity350. Using the measured depth the surgeon may select a locking screw232. The selected locking screw232may then be inserted into the cavity350to secure the nail200in position in the first bone262and the second bone264. After the locking screw232is inserted the position and stability of the nail200may be verified using fluoroscopy. Once the position of the nail200is verified a cap252may be inserted into the fastening end206to prevent bone ingrowth or overgrowth in order to maintain the ability to remove nail200if necessary or desired. The cap may include securing means to secure the cap to the nail200to prevent disengagement of the cap. Next, in step376, the incision over the joint260may be closed by the surgeon.

Referring now toFIGS.33-54, with specific reference toFIGS.33and34showing an exemplary embodiment fixation guide device400. The fixation guide device400may include an outrigger assembly or frame402, a compression device440, and an intramedullary nail500. The outrigger assembly402, shown inFIGS.35and36, includes a base404with a lateral wing or outwardly extending wing414including a first drill hole406, a second drill hole408, a third drill hole410, a fourth drill hole412, and a proximal arm416. It is also contemplated that the frame402may include, for example, a plurality of drill holes to correspond to the number of openings in an intramedullary nail, for example, nail200,500,700in order to secure the intramedullary nail to the patient's bones. The drill holes406,408,410,412may each include, for example, multiple holes spaced a small distance apart or multiple nested or overlapping holes to correspond to the openings508,510,512,514in various sized intramedullary nails500. The base404may include at least one opening420allowing for visualization through the base404with imaging technology, such as x-ray. The proximal arm416is perpendicular to the base404at a proximal end of the outrigger assembly402and includes a knob opening424, a nail attachment opening426, and a nail attachment portion428. The nail attachment portion428may include an end with an inverted two step profile including a first step or nail attachment segment480and a second step or nail attachment segment482. The base404may ideally be made of a material that is strong enough to prevent deformation during surgery, such as, a metal, while also being radiolucent, for example, carbon fiber, to allow for imaging through the base404to determine whether correct alignment of the nail500was achieved.

The compression device440slidingly mates with the nail attachment portion428. The compression device440includes a compression member442, a knob444, and a bolt446. As best seen inFIGS.37-38, the compression member442has a base458with a top end448and a bottom end450. The compression member442also includes a protrusion460at the bottom end450, a first opening452near the top end448for receiving the bolt446, and a second opening454near the bottom end450passing through the base458and protrusion460. The compression member442may be of the type described above with reference to the compression member142and will not be described again here for brevity sake The second opening454is slidingly engaged with the nail attachment portion428. The compression member442may also include a midpoint462and teeth464on the angled portion of the protrusion460, as described above with reference to compression member142.

As depicted, after the compression member442is slid over nail attachment portion428, the knob144may be secured to the base404using a bolt146and fastener inserted into opening170. The knob144, shown inFIG.7, and the bolt146, illustrated inFIG.8, are both described above with reference to the fixation guide device100. The threaded end156of bolt146may be inserted into the knob opening424and the threaded end156mates with the threads of the second opening454. The stop member166of the bolt146may prevent the bolt146from passing through the knob opening424.

Referring now toFIGS.39-40with continued reference toFIGS.33-34, the intramedullary nail500may be of the type described above with reference to nail200and may include a body502with a closed end504, a fastening end506with an insertion opening516and an engagement opening518, and four openings508,510,512,514. It is also contemplated that the intramedullary nail500may include any number of openings508,510,512,514as may be necessary to secure the nail to a patient's bones. The insertion opening516may be used to secure the nail500to the nail attachment portion428using an engagement fastener220, for example, a screw, such as the one illustrated inFIG.11.

The engagement opening518may be a threaded opening, with threads546, that passes through the exterior surface of nail500to secure the nail500to the bone using a locking screw532. The locking screw532, as depicted inFIG.41, may include a head534with a drive opening536and a shank538with a first threaded section540, a smooth section542, and a second threaded section544, as described above with reference to locking screw232and which will not be described again here for brevity sake.

The nail500may also include a fastening end506with a shape that corresponds to the shape of the end of the nail attachment portion428to create a tight fit between the nail500and the attachment portion428. As depicted inFIGS.39-40, the fastening end506, may be of the type described above with reference to fastening end206, and includes a two step profile including a first step or fastening segment548and a second step or fastening segment550. Thus, the nail500may be secured to the outrigger assembly402, as described above with reference toFIGS.9-10.

The surgical method for inserting the intramedullary nail500into a patient's joint560may include the steps ofFIG.55, as illustrated inFIGS.42A-54. The method utilizes some of the devices, instruments, features, aspects, components, and the like described above with reference to the fixation guide device400, and therefore reference will be made to the above described embodiments illustrated inFIGS.33-41and discussed above. However, such references are made for exemplary purposes only and are not intended to limit the surgical method beyond the specifically recited steps. Further, the surgical method may be discussed under the umbrella of particular bones, but such an application is not intended to be limiting and the method described herein may be used or conducted with bone or other tissue not specifically discussed herein without departing from the spirit and scope of the surgical method.

If a joint560, for example, a metatarsal phalangeal joint or the like, needs to be surgically fixed, a surgeon would first expose the joint560by creating an incision over the joint560as in step352. Next, in step354, the first bone262and the third bone564of the joint560will be prepared by using a cut guide and cartilage removal technique such as a curet, osteotome, saw blade, or other similar cartilage removal technique known by one skilled in the art. The joint560is then aligned by moving the first bone262and third bone564into a desired position for fixation. Once the bones262,564are aligned, temporary fixation may be applied to hold the joint560in the desired position. A guidewire, template, or similar clamp may be used to temporarily fix the joint560.

Next, in step356, shown inFIG.42A, an alignment guide522, as illustrated inFIGS.42B-42F, is aligned with the patient's first bone262and third bone564. The alignment guide522includes a base member524with an alignment member526and a fixation guide or temporary fixation guide528. The base member524includes a first member and a second member. The alignment member526couples to the base member524for alignment of the first bone262and the third bone564. The alignment member526may be coupled to the base member524by, for example, pins552on the alignment member526which engage openings554on the base member524, as shown inFIG.42D. When the alignment member526is coupled to the base member524the alignment portion558aligns the alignment member526relative to the second member of the base member524. The alignment portion558may be angled at a desired angle, which may range from, for example, approximately 0 degrees to 25 degrees and more preferably from approximately 10 degrees to 15 degrees. The alignment portion558allows a surgeon to maintain the desired alignment of the first bone262and third bone564of the patient's toe.

Once the guide522is aligned, at least two guidewires530may be inserted into through holes or openings556to temporarily fix the guide522to the first bone262and third bone564. After temporarily fixing the guide522to the first and third bones262,564the fixation guide528may be inserted into one of the holes566in the first member of the base member524providing the desired path through the patient's joint. The fixation guide528may include a head568, a shaft570extending out from the head568and a through hole572extending through the center of the head568and the shaft570. After inserting the fixation guide528into the desired hole566a guidewire530may be inserted into the through hole572of the temporary fixation guide528and into the bone262and third bone564across the joint. The guidewire530inserted into the temporary fixation guide528may be positioned to be used as a drilling guide for the intramedullary nail500. Once the guidewire530is inserted across the joint560the alignment guide522may be removed, leaving the guidewire530in position for drilling a cavity for the nail500.

Alternatively, step356may be performed as shown inFIG.43A, using the alignment guide576, as illustrated inFIG.43B, wherein the guide576is aligned with the patient's first bone262. The alignment guide576includes a body578with a distal end which includes a pointed end580and a drill guide portion582at the proximal end of the body578. The drill guide portion582includes a bone mating portion584and a center channel586for the drill to pass through. The pointed end580aligns with the distal end of the first bone262. Once the guide576is aligned, a guidewire may be inserted through a center channel586and into the distal end562of the first bone262and the third bone564. The guidewire may be positioned to be used as a drilling guide for the intramedullary nail500. Once the guidewire is inserted across the joint560the alignment guide576may be removed, leaving the guidewire in position for drilling a cavity for the nail500.

A depth gauge (not shown) may then be used to determine the length of the intramedullary nail500to be used, as described above with reference to determining the length of nail200, which will not be described again here for brevity sake. Next, in step358, a cavity588for the nail500is drilled, as described above with reference to drilling cavity288, and nail500is inserted, as illustrated inFIG.44.

Next, in step360, a fixation guide device400may be selected. Then, in step362, as depicted inFIGS.33and34, the nail500may then be loaded onto the outrigger assembly402creating the fixation guide device400for use during insertion and fixation of the nail500into the cavity588, as described above with reference to nail200and outrigger assembly102. Next, in step364, as shown inFIG.45, the fixation guide device400may then be oriented to allow the surgeon to insert the nail500into the pre-drilled cavity588, as described above with reference to insertion of nail200, which will not be described again here for brevity sake. The nail500may be countersunk in the cavity588, approximately two to three millimeters depending on pre-operative assessment.

Referring now toFIG.46, drill sleeves590are shown inserted into a first drill opening406, a second drill opening408, a third drill opening410, and a fourth drill opening412of the base404. The drill sleeves590include a sleeve portion592with a stop member594at the top and an opening596through the center of the sleeve portion592, as depicted inFIG.47. The diameter of the opening596may be the same size as the drill bit used to drill cavities into the first and second bones262,564. The cavities are drilled through the opening596in the drill sleeve590and the openings508,510,512, and514in the nail500.

Referring now toFIGS.46and48, the nail500is shown fixed into the bones262,564using four pegs or fasteners600,620,640, and660. Referring now toFIGS.49-52, the first peg600, second peg620, third peg640, and fourth peg660each include a shaft602,624,644,664, respectively, with a proximal end and a distal end. The proximal ends include a head604,626,646,666, an upper threaded section606,628,648,668, and a notch608,630,650,670. In the depicted embodiment the heads604,626,646,666may be hexagonal heads, although other head shapes, such as, a flathead, Phillips head, other multi-lobed configurations, and the like are also contemplated. The distal ends include a lower threaded section610,632,652,672with a pointed end612,634,654,674and a notch614,636,656,676. Between the proximal ends and distal ends of the shafts602,624,644,664there may be a smooth region which mates with the first opening508, second opening510, third opening512, fourth opening514, respectively, of the nail500.

Once the nail500is inserted into the cavity588it will be secured to the bones262,564using at least two pegs, in the depicted embodiment four pegs600,620,640, and660are used. Next, in step366, as shown inFIG.48, the surgeon may secure the nail500by inserting the first peg600into a first cavity598in the third bone564, as described above with reference to drilling, measuring, and inserting the first peg300, which will not be described again here for brevity sake.

Next, in step368, the first peg600may then be used as a counter force for compression as knob144is turned forcing compression member442to move distally and exert force on the first bone262as the first peg600holds the third bone564in place. As compression member442is moved the first bone262and third bone564are compressed at joint560. Once the desired compression has been achieved, in step370, a second peg620may be inserted using drill sleeve590to drill a second cavity622in the first bone262, as described above with reference to second cavity322. After the second cavity622is drilled the depth of the cavity622may be measured and the length of a second peg620selected, as described above with reference to second peg320which will not be described again here for brevity sake. The second peg620may then be inserted through the second drill opening408and into the second cavity622, as shown inFIG.48. The insertion of the second peg620may secure the achieved compression to prevent the loss of compression.

With continued reference toFIGS.46and48, the drill sleeve590may also be inserted into the third drill hole410. A drill may then be inserted into opening596in the drill sleeve590to drill a third cavity642into the third bone564. The third cavity642may pass through the third opening512in nail500. After the third cavity642is drilled a depth gauge may be inserted into the third cavity642through the drill sleeve590to measure the depth of the third cavity642. Then the depth gauge and the drill sleeve590may be removed from the third drill opening410. Using the measured depth, the surgeon may select a third peg640with the desired length. The third peg640may then be inserted through the third drill hole410and into the third cavity642, as shown inFIG.48. The insertion of the third peg640adds additional stability to the compression of the bones262,564.

The drill sleeve590may also be inserted into the fourth drill hole412, as illustrated inFIG.46. A drill may then be inserted into the opening596in the drill sleeve590to drill a fourth cavity662into the first bone262. The fourth cavity662may pass through the fourth opening514in the nail500. After the fourth cavity662is drilled a depth gauge may be inserted into the fourth cavity662through the drill sleeve590to measure the depth of the fourth cavity662. Then the depth gauge and the drill sleeve590may be removed. Using the measured depth, the surgeon may select a fourth peg660with the desire length. The fourth peg660may then be inserted through the fourth drill opening412and into the fourth cavity662, as illustrated inFIG.48. The insertion of the fourth peg660may provide additional stability to the compression of the first bone262and the third bone564.

Referring now toFIGS.53and54, once at least the first and second peg600,620, although all four pegs600,620,640, and660are shown in the depicted embodiment, are inserted into the first and third bones262,564, respectively, nail500may be detached from the outrigger assembly402and the fixation guide device400may be removed from the patient's foot, in step372. Next, in step374, a threaded locking drill guide may be threaded or not threaded for inserting the locking screw532into the first bone262through the engagement opening518of the intramedullary nail500. Once the locking drill guide is secured, a cavity680for the locking screw532may be drilled through the engagement opening518and the depth measured, as described above with reference to drilling cavity350which will not be described again for brevity sake. Using the measured depth, the surgeon may select a locking screw532and insert the screw532into the cavity680to secure the nail500in position in the first bone262and the third bone564. After the locking screw532is inserted the position and stability of the nail500may be verified using fluoroscopy. Once the position of the nail500is verified, a cap may be inserted into the fastening end506to prevent bone ingrowth or overgrowth in order to maintain the ability to remove nail500if necessary or desired. The cap may also include securing means to secure the cap to the nail500to prevent disengagement of the cap. Then, in step376, the incision over the joint560may be closed by the surgeon.

Alternative intramedullary nails, for example, nail700, as shown inFIGS.56-59, may be used to replace intramedullary nails200and500. The nail700may include a body702, a closed end704, a compression end or fastening end706, and four openings708,710,712, and714. The four openings708,710,712, and714may be disposed on independent planes and angularly spaced apart relative to each other. The amount of longitudinal and rotational movement of the nail700is limited by placing the four openings708,710,712, and714at opposing angles oblique to the longitudinal axis of the nail700. It is also contemplated that the intramedullary nail700may include any number of openings708,710,712,714as may be necessary to secure the nail to a patient's bones with limited or no rotational or longitudinal movement after implantation. The second opening710may be an elongated opening to enable compression of a joint732which is medial the first opening708and the second opening710and configured to receive fastener726. While the first opening708, third opening712, and fourth opening714may be configured to receive fasteners724,728,730, respectively, and prevent movement along the longitudinal axis of the body702. Alternative fasteners may also be used with the intramedullary nail700, for example, fasteners or pegs300, as shown inFIG.21, and600,620,640,660, as shown inFIGS.49-52. The compression end706includes a cam opening or insertion opening716, which may be threaded, and a cam or cam member718for insertion into the cam opening716. The cam718may include exterior threads720for engaging the threads of the cam opening716and a drive opening722.

The intramedullary nail700may be used during surgery to compress a joint732, which may be, for example, joints260,560described in greater detail above. The nail700may be inserted into a patient in place of nails200and500. Once inserted into a cavity within the patient's bones734,736which passes through a patient's joint732, the surgeon may insert a first fastener724into the first opening708and into the second bone736. Next a second fastener726may be inserted into the first bone734through the second or elongated opening710at a position within the opening710closest to the compression end706. Then a screw driver, not shown, may be inserted to engage the drive opening722of the cam718and turned to advance the cam718along the cam opening716. As the cam718is advanced along the cam opening716into the body702of the nail700, the cam718engages the shaft of the second fastener726, as shown inFIG.57, and pushes the second fastener726along the elongated opening710to compress the first bone734and second bone736of the joint732. Once the desired compression is achieved, a third fastener728may be inserted into the first bone734through the third opening712to secure the joint732in compression. A fourth fastener730may be inserted into the second bone736through the fourth opening714to secure the joint732in compression.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.