# Patent

## Title
Ankle arthrodesis nail and outrigger assembly

## Abstract

An intramedullary fixation device having a distal section; a proximal section; a connecting member for adjustably securing the distal and proximal sections end to end along a longitudinal axis; a screw securing the proximal section to a first bone; and a screw securing the distal section to a least one different bone. The connecting member is rotated to provide compression across a bone arthrodesis site to be stabilized and fused. Also described is a method of utilizing the intramedullary fixation device with an outrigger assembly.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Application No. 61/079,132, filed on Jul. 9, 2008, entitled “ARTHRODESIS NAIL OUTRIGGER ASSEMBLY” and to U.S. Provisional Application No. 61/079,130 filed on Jul. 9, 2008, entitled “ANKLE ARTHRODESIS NAIL AND OUTRIGGER ASSEMBLY” which are incorporated herein by reference in their entirety as if set forth in full.


FIELD OF THE INVENTION
The present invention relates to surgical and bone fusion devices and systems in general, and more particularly to an improved arthrodesis nail that enables the bone fusion site to be sufficiently compression prior to fusion, and more particularly still to an improved outrigger assembly and method for implanting an arthrodesis nail.
BACKGROUND OF THE INVENTION
The lower limbs of the human body, namely the femur (thigh bone), the tibia (shinbone), and fibula, are designed to bear the weight of the body and to provide the body with sufficient stability. The femur courses medially from its proximal end connected to the hip bone to its distal end connected to the knee, placing the knee joints closer to the body's center of gravity and thus giving the body better balance while walking or standing. The tibia and fibula, which are connected together by an interosseous membrane, extend in parallel from the knee to ankle, with the tibia being larger and located medially in relation to the fibula. The tibia articulates proximally with the femur, forming the hinge joint of the knee, and distally with the talus bone of the foot at the ankle, and as such receives most of the body's weight and transmits it to the foot, while the fibula, which articulates proximally and distally with the lateral aspects of the tibia, is a non-weight bearing bone and generally provides stability for the ankle joint. The shaft of the tibia is generally triangular in cross section, and its distal end is blunt where it articulates with the talus. Situated medially to such distal tibia end is the medial malleolus, and a fibular notch is provided on the lateral surface of the tibia opposite the medial malleolus.
The foot skeleton is made up of the tarsus, metatarsus, and phalanges bones, with the tarsus bones forming the proximal or heel end of the foot, the metatarsus bones forming the bases of the toes, and the phalanges being the toe bones. The tarsal bones include the talus, calcaneus, lateral cuboid, medial navicular, and medial, intermediate, and lateral cuneiform bones. The talus articulates with the tibia and fibula superiorly and is located on the upper surface of the calcaneus bone, which forms the heel and with the part that touches the ground the tuber calcanei, and such bones support most of the weight of the body, although some weight is distributed to the heads of the metatarsals by the arching of the foot. In some patients the ankle joint or interconnection of the lower end of the tibia, the fibula, and the talus (spaced apart by articular cartilage and held together by various ligaments) can become worn or injured due to a degenerative condition or deformity, or a fracture, subluxation, or other traumatic event. In order to stabilize the ankle joint and control the often severe pain caused by such conditions, an arthrodesis procedure may be necessary to fuse and therefore permanently immobilize the ankle joint, fusing the distal end of the tibia with the talus. Where both the tibi-talar and talocalcaneal joints are damaged, such as in some patients having severe osteoporosis, the calcaneus bone will also be fused with the ankle. Such tibiotalacalcaneal arthrodesis procedures today are typically accomplished by permanent intramedullary nailing, wherein after the ankle bone surfaces have been prepared a rigid nail or rod is inserted in a hole drilled upwardly through the calcaneus and talus bones and into the medullary canal of the tibia. Screws are passed laterally through holes drilled in the tibia to hold the proximal end of the nail in place in the tibia, and into the nail through holes drilled in the calcaneus and talus bones. A limitation of known intramedullary or tibio-calcaneal arthrodesis nailing systems is in obtaining sufficient compression across the arthrodesis site so that a proper fusion is accomplished. The present inventor has devised an arthrodesis implant or intramedullary nail and system wherein proper compression across the arthrodesis site can be obtained, as well as an improved arthrodesis nail outrigger assembly.
OBJECTS OF THE INVENTION
It is therefore a primary object of the invention to provide both an arthrodesis implant which is simple, easy to install and effective, as well as an arthrodesis outrigger assembly for use with such implant which is effective during an arthrodesis operation for proper alignment and implantation of the arthrodesis implant.
It is a still further object of the invention to provide an arthrodesis implant which can be relatively easily implanted in the foot and ankle and quickly, easily and effectively secured in place.
It is a still further object of the invention to provide an arthrodesis prosthesis which is formed in two main sections which are adjustably secured together by an intervening rotatable adapter effective from the bottom of the arthrodesis prosthesis to compress or place tension on the leg and ankle bones to be fused.
It is a still further object of the invention to provide an arthrodesis implant which is formed in two main sections adjustably secured together by a central rotating fitting which in combination with an external compression disc are used to provide tension from and through the foot bone to provide compression of the bones in an arthrodesis site prior to insertion of retaining screws used to immobilize the foot bones after which the compression disc can be removed.
It is a still further object of the invention to provide an improved arthrodesis nail outrigger assembly adapted for guiding an arthrodesis tool into the foot and leg bones applying an external compression disc and retaining screws after which the outrigger assembly can be removed.
It is a still further object of the invention to provide an arthrodesis nail outrigger assembly wherein the outrigger assembly can be adjustably rotated around an arthrodesis with respect to a stationary intramedullary nail device.
It is a still further object of the invention to provide an arthrodesis nail outrigger assembly having a cannulated nail mounting shaft arrangement to allow for compression of a two-sectioned intramedullary nail device, resulting in a more tightly compressed and stable tibio-calcaneal arthrodesis.
Still other objects and advantages of the invention will become clear upon review of the following detailed description in conjunction with the appended drawings.
SUMMARY OF THE INVENTION
An intramedullary fastener or nail is provided having which nail is formed in two sections which are adjustably joined together by an internal bolt member which can be rotated to decrease the total length of the combined nail and thus is capable of providing compression across an arthrodesis site in a tibio-calcaneal arthrodesis nailing procedure. After the nail has been inserted upwardly through holes drilled in the calcaneus and talus bones and tibia, using an outrigger assembly such nail is first secured to the tibia, after which the outrigger assembly in combination which a compression disc provided at the distal end of the nail is used to rotate the internal bolt member causing the distal or lower section of the nail and compression disc to move upwardly toward the proximal or upper section, providing compression of the calcaneus and talus bones with the tibia so that any spaces between the joints are closed prior to securing the bones in such position. In addition, an improved outrigger assembly is provided which enables the outrigger handle to be rotated and secured at ninety degree angles with respect to the stationary intramedullary nail, that also provides superior stability and ease of use, and having a cannulated nail mounting shaft which enables an adjustment to be inserted through the shaft upwardly into the nail to adjust the position of the bolt member and provide the desired amount of compression across the arthrodesis site. In addition, the amount of compression across the arthrodesis site can be adjusted at a later date via a minimally invasive procedure.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial cross-sectional view of the intramedullary fixation device of the present invention along its longitudinal axis in an uncompressed configuration.
FIG. 2 is a side view of the intramedullary fixation device of the present invention as applied to an ankle joint in an uncompressed configuration.
FIG. 3 is a side view of the fixation device shown in FIG. 2 as applied to an ankle joint in a fully compressed configuration.
FIG. 4A is a top view of a compression disc used with the intramedullary fixation device of the present invention.
FIG. 4B is a side view of the intramedullary fixation device and the compression disc of the present invention as applied to an ankle joint in an uncompressed configuration.
FIG. 5 is a side view of the proximal section of the intramedullary fixation device of the present invention.
FIG. 6A is a side view of the distal section of the intramedullary fixation device of the present invention.
FIG. 6B is a view of the distal section of the intramedullary fixation device of the present invention taken along the line B in FIG. 6A.
FIG. 6C is a view of the distal section of the intramedullary fixation device of the present invention taken along the line C in FIG. 6A.
FIG. 7 is a side view of the compression bolt member of the intramedullary fixation device of the present invention.
FIG. 8 is a side view of the bolt retainer member of the present invention.
FIG. 9 is a cross-sectional view of the intramedullary fixation device as shown in FIG. 1 in a compressed configuration.
FIG. 10 is a side view of the intramedullary fixation device of the present invention in an uncompressed configuration.
FIG. 11 is a proximal end view of a section of the intramedullary fixation device of the present invention.
FIG. 12 is a perspective view from the side of the outrigger assembly and intramedullary fixation device of the present invention.
FIG. 13 is a side view of the outrigger assembly and intramedullary fixation device of the present invention.
FIG. 14 is a perspective view from the top of the outrigger assembly and intramedullary fixation device of the present invention.
FIG. 15 is an exploded view from the side of the outrigger assembly of the present invention.
FIG. 16 is an exploded view from the top of the outrigger assembly of the present invention.
FIG. 17 is a cross-sectional view from the side of the outrigger assembly of the present invention.
FIG. 18 is a side view of the intramedullary fixation device of the present invention as applied to an fifth metatarsal fracture in an uncompressed configuration.
FIG. 19 is a side view of the intramedullary fixation device of the present invention as applied to an long bone fracture in an uncompressed configuration.
FIG. 20 is a side view of the intramedullary fixation device of the present invention as applied to subtalar joint fusion in an uncompressed configuration.



DESCRIPTION OF THE PREFERRED EMBODIMENTS
The following detailed description is of the best mode or modes of the invention presently contemplated. Such description is not intended to be understood in a limiting sense, but to be an example of the invention presented solely for illustration thereof, and by reference to which in connection with the following description and the accompanying drawings one skilled in the art may be advised of the advantages and construction of the invention. The invention is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims.
FIGS. 1-11 illustrate the intramedullary fixation device of the present invention, FIGS. 12-14 and 17 illustrate the combination intramedullary fixation device and outrigger assembly, and FIGS. 15-16 illustrate the outrigger assembly alone. Referring to FIG. 1, there is shown an embodiment of the intramedullary fixation device 12 of the present invention for stabilizing the position of and fusing together the tibia T (shin bone) relative to the talus A (adjoining ankle) and calcaneus C (heel) bones, and which is to be inserted through the bottom of the foot into the medullary canal of the tibia. Intramedullary nail 12 is comprised of two main sections, referred to generally herein as proximal section 14 and distal section 16. In addition, compression bolt 18 (see FIG. 7) is used to join proximal section 14 to distal section 16, and in addition to provide the required tension or compression of the ankle joint once installed, as will also be described in detail below. In addition, alignment outrigger device 20 (FIG. 16) is provided, which is used to precisely position nail 12 in the tibia T and fixed to the talus A and calcaneus C bones. Also shown in FIG. 16 is driving device 24 which is used to adjust compression bolt 18.
Proximal 14 and distal 16 sections of intramedullary nail 12 generally have a rounded or circular shape, and are preferably made of surgical stainless steel or surgical stainless titanium, and correspond generally to the-shape of the tibia medullary canal. Referring more particularly now to FIG. 5, proximal section 14 of nail 12 has a forward end 25 and a rearward end 26, and is slightly tapered along its longitudinal axis 23 from rearward end 26 to forward end 25, the outer surface of which end is preferably smooth and rounded. Through-holes 28 extending perpendicular to longitudinal axis 23 are spaced apart in the shaft of proximal section 14 near forward end 25, through which holes 28 support screws 30 (see FIG. 1) are passed to secure proximal section 14 of nail 12 to the tibia bone in position in the tibia medullary canal. It will be understood that screws 30 may have different lengths and sizes as required and known to those skilled in the art. A bore 32 extends inwardly from the rearward end 26 of proximal section 14 along longitudinal axis 23, forming non-threaded sleeve area 34 adjacent rearward end 26, a short non-threaded section 35 adjacent sleeve area 34 and having a smaller diameter than sleeve area 34, with inwardly extending circumferential bearing surface 37 formed between areas 34 and 35, and extending inwardly from short section 35 an internal screwthreaded area 36 for receiving compression bolt 18. See also FIGS. 1 and 9. In addition, at least one alignment notch 38 is provided in sleeve area 34 adjacent rearward end 26, for receiving corresponding tab in distal section 16 and for properly aligning the sections of nail 12 in the manner described below.
As shown in FIG. 6A, distal section 16 of nail 12 has an upper end 40 and a lower end 41, and is preferably slightly tapered from lower end 41 to upper end 40 along its longitudinal axis 42. A plurality of holes 44 are situated in distal section 16 near lower end 41 extending perpendicular to longitudinal axis 42 and spaced apart a predetermined distance, for receiving screws 30 passed through the talus and calcaneus bones. Situated on the upper end 40 of distal section 16 is arm 46 having a reduced outer diameter and being sized to be slidingly received in sleeve 34 of bore 32 in proximal section 14, while as best shown in FIGS. 1 and 9 a bore 48 extends through distal section 16 from upper end 40 to lower end 41, which bore 48 has a smaller diameter section 49 adjacent upper end 40 and arm 46, and a larger diameter section 50, with inwardly extending bearing surface or end wall 51 between such sections. Threads 52 are provided in the inner walls of larger diameter section 50 of bore 48 adjacent lower end 41, while a plurality of spaced apart rectangular notches 54 are formed in lower end 41.
Bore 48 is sized to receive compression bolt 18, best shown in FIG. 7, which bolt has a reduced diameter section 60 and a larger diameter head section 62, forming outwardly extending bearing surface 63 between sections 60 and 62. Reduced diameter section 60 includes a threaded section 64, a non-threaded shaft section 66, a shallow notch 67 situated between such sections, and head section 68. A socket 70 is provided in the end surface of enlarged diameter section 62 to facilitate rotating bolt 18 in either a clockwise or counterclockwise direction using driving device 24 as described in more detail below. As shown in FIGS. 1 and 9, head section 62 of compression bolt 18 is sized to be received in bore 50 of distal section 16 of nail 12, while at the same time reduced diameter section 60 of bolt 18 is passed through bore sections 50, with threaded section 64 extending outwardly through forward end 40 while shaft section 66 remains in bore 49 in arm 46. When arm 46 is inserted in sleeve 34, male threaded section 64 is received on the female threads in bore section 36, and when rotated on the threads arm 46 is pulled towards sleeve 34 until bearing surface 63 of head section 62 engages against bearing surface 51 in bore 50. Compression bolt 18 is adjustably secured to proximal section 14 by clip 72, shown in FIG. 8, which clip is secured around the outer surface of bolt 18 in slot 67, to prevent threaded section 64 from being moved outwardly out of bore 32 past sleeve section 34.
The present inventor's system also includes an improved outrigger assembly 20, shown alone in FIGS. 15-16 and with nail 12 attached in FIGS. 12-14 and 17, which assembly 20 is used to properly position and align intramedullary fixation device 12 while it is being inserted and secured in the patient's tibia medullary canal and then while a compressive for is applied across the arthrodesis site. Outrigger assembly 20 includes an alignment beam 80 that is detachably and adjustably secured to handle 82 in a slot 83 along one side edge of handle 82 so that the beam extends outwardly from the handle, while a nail engaging shaft 84 is secured to handle 82 in an aperture 85 along the opposite side edge of the handle, so that nail 12 when engaged with shaft 84 is spaced apart and in parallel with beam 80. Outrigger assembly 20 is preferably made of carbon fiber which is radiolucent and thus does not appear in x-rays, although other materials such as surgical stainless steel may be used.
Beam 80 is secured in slot 83 by two different locking mechanisms on opposite sides of the slot. The first of these is a threaded pin 86 which is threadably secured in an aperture 87 in handle 82, which aperture 87 extends laterally between the outer side surface of handle 82 and slot 83. Thus, when pin 86 is inserted in aperture 87 with beam 80 in slot 83 and tightened, its forward end extends through aperture 87 and presses against the side surface of beam 80, preferably in one of several notches 88 (see FIG. 17) in the corresponding side surface of beam 80, to hold it in place in slot 83. Pin stop 89 also engages with beam 80. The second locking mechanism is provided on the opposite side of slot 83 in handle 82. As shown in the cross sectional view in FIG. 17, an angled aperture 90 is provided in handle 82 having a larger diameter end section 92, a reduced diameter center section 94, and second reduced diameter section 96 terminating at slot 83. In addition, a transverse slot 98 is cut out in handle 82 extending through reduced diameter center section 94. Aperture 90 receives a lock shaft 100 having a head section 102, a non-threaded shaft section 104, a threaded shaft section 106, and a forward non-threaded pin section 108. Head section 102 is sized to be received in end section 92 of aperture 90, shaft sections 104 and 106 are sized to be received in center section 94 of aperture 90, and pin section 108 is sized to be received in section 96 of aperture 90. Lock spring 110 is placed around non-threaded shaft section 104, while adjustor knob 112 is secured over threaded shaft section 106 in transverse slot 98, such that turning knob 112 causes lock shaft 100 to move either forwardly or rearwardly in aperture 90, with the forward end of pin section 108 extending into one of several similarly angle apertures 114 in beam 80, thereby locking beam 80 in place. Notches 116 aligned with apertures 114 are also provided in beam 80, which when aligned properly with handle 82 engage teeth 117 on the inner surface of slot 83 adjacent second reduced diameter section 96 of aperture 90. Thus, the tension on beam 80 can be adjusted on one side by rotating knob 112, and on the other side using threaded pin 86 to ensure that such tension is generally equal and further than beam 80 is locked in place.
Intramedullary fixation device mounting shaft 84 has a bottom section 118 that is generally square or rectangular and fits in aperture 85 in handle 82, a slide lock receiving section 120 adjacent bottom section 118, a short conical section 122 adjacent slide lock receiving section 120, a second short enlarged diameter section 124 adjacent conical section 122, and a shaft section 126 for engaging with nail 12. Cavity 128 extends through nail mounting shaft 84, and alignment tabs 130 that engage with notches 54 in the outer end 41 of distal section 16 of nail 12 as well as notches 154 on compression disc 150, shown in FIG. 4, are provided on the outer end of shaft section 126. Another slot 134 and associated notch 135 (see FIG. 17) are provided in the side surface of handle 82 adjacent aperture 85, in which slide lock device 136 is inserted. Slide lock device 136 has a head or button section 138, a rectangular shaft section 140 having a lateral through hole 142, and a pin section 144 extending forwardly from shaft section 140, around which pin 144 coil spring 146 is secured. When bottom section 118 of nail mounting shaft 84 is inserted in aperture 85, first slide lock device 136 is inserted in aperture 134 until lateral hole 142 is aligned with aperture 85, and bottom section 118 is passed through lateral hole 142, and slide lock receiving section 120, which section has a width that is slightly greater than the width of shaft section 140, is aligned in hole 142. Slide lock device 136 serves as a position stop locking device, as spring 146 causes shaft section 140 to press against the side surface of slide lock receiving section 120, thereby locking nail receiving shaft 84 in place secured to handle 82. When button 138 on slide lock device 136 is pressed inwardly, shaft 84 is released and outrigger assembly 20 can be swiveled or rotated with respect to shaft 84 and nail 12 in a three hundred sixty degree range around shaft 84 and nail 12, and can be stopped and locked at ninety degree intervals. Such unique feature enables the outrigger assembly to be rotated to different positions or angles around a patient's legs as desired, with the nail 12 remaining stationary or fixed to the patient's tibia. This may be desired in some cases where the outrigger assembly is in the surgeon's way while another step or task is being performed, and allows the assembly to be moved out of the way and then back again after a task has been completed, or where the outrigger assembly must be moved in order to complete the operation.
Nail 12 is secured to outrigger assembly 20 as follows. The notches 54 in the lower end 41 of distal section 16 of intramedullary fixation device or nail assembly 12 are aligned in the desired position with tabs 130 on the outer end of shaft section 126 of nail mounting shaft 84. In addition, compression disc 150, shown in FIG. 4A, is positioned between lower end 41 of nail 12 and tabs 130 so that it will be held between the lower end of the nail and forward end of shaft section 126. As shown in FIG. 4A, disc 150 has an aperture 152 through its center area, to accommodate shaft section 126 passing through such aperture. The purpose of disc 150 is to prevent the lower end of nail 12 from pulling upwardly into the calcaneus or heel bone when the bolt 18 is rotated to bring the distal section 16 of nail 12 upwardly to proximal section 14. Rather, with compression disc 150 abutting against the bottom surface of the patient's heel, the upward movement of distal section 16 will cause the spaces between the lower end of the tibia and top surface of the talus, as well as between the bottom surface of the talus and top surface of the calcaneus, to shrink and eventually be eliminated, as shown in FIGS. 2 and 3, and resulting in a desirably compressed ankle joint. In a preferred embodiment, the compression disc 150 is placed against the heel bone internal to the body. In an alternate embodiment, the compression disc 150 is placed against the heel bone external to the body.
Once alignment tabs 130 on the outer end of shaft 84 have been engaged with notches 54 on the lower end 41 of nail 12, with compression disc 150 inserted in-between, then nail attachment device 160 is used to secure nail 12 to shaft 84. As is best illustrated in FIG. 17, device 160 is comprised essentially of a knob 162 attached to one end of an elongated shaft 164 having male threads 166 on its opposite end. Shaft 164 is sized to be slidably received in cavity 128 in nail mounting shaft 84, and in addition a cavity 168 extends through shaft 164 from end to end. Male threads 166 are engaged with female threads 52 on the lower end of distal section 16 of fixation device 12, and causing nail 12 to be tightly secured to mounting shaft 84. Note also that compression bolt 18 is already positioned in nails sections 14 and 16, and that nail 12 is in an uncompressed state. After a hole has been is drilled upwardly through the bottom of the calcaneal bone C, talus A (if not so eroded or degraded that it no longer separates the tibia from the calcaneal bone) and into the medullary canal the tibea T and cleaned out appropriately using techniques known to those skilled in the art, the forward end 25 of proximal section 14 of nail 12 is inserted upwardly into such hole into the tibia, also in the known manner. Screw holes 170 are provided in the distal end of beam 80, which during use of outrigger assembly 20 are aligned with holes 28 in proximal section 14 of nail 12. Similarly, similarly screw holes 172 in beam 80 will be aligned with holes 44 in distal section 16 of nail 12, to ensure that screws 30 are properly positioned and aligned with inserted through the tibia, talus, and calcaneus. Using outrigger assembly 20, holes are then drilled into the tibia, which holes are aligned with holes 28 in nail 12, and then screws 30 are inserted in such holes to secure proximal section 14 of nail 12 in position in the tibia. Then, compression driver 24 is used rotate bolt 18, which movement causes distal section 16 to move upwardly towards proximal section 14. As shown in FIG. 16, compression driver 24 has a handle section 180, a shaft or blade section 182 and a tip 184 which is designed to match and be received in socket 70 in the end of bolt 18. Blade section 182 is sized to slidingly fit through cavity 168 in nail attachment device 160, and is long enough so that tip 184 can be engaged with socket 70 in bolt 18. Bolt 18 is turned so that threaded shaft section 64 is moved upwardly into threaded section 36 if proximal section 14 of nail 12, causing distal section 16 to slowly move upwardly toward distal section 18. As indicated above and as is best illustrated in FIGS. 3 and 4, such movement causes the calcaneus and talus bones to also be forced to moved upwardly toward the lower end of the tibia. Eventually, by continuing to rotate driver 24 to turn bolt 18, an adequate amount of compression of the ankle joint will be accomplished, after which driver 24 may be removed from cavity 168 in mounting shaft 84. Then, the surgeon must secure the talus and calcaneus bones in such a compressed position against the lower end of the tibia, and this is accomplished by drilling the appropriate holes in the talus and calcaneus through orifices 172 in beam 80 of outrigger assembly 20, and the inserting screws through such holes and into holes 44 in distal section 16 of nail 12. Once properly secured, nail attachment device 160 can be removed from the lower end 41 of nail 12, and compression plate 150 will also be coincidingly removed. Preferably a suitable screw threaded cap will be placed over the lower end of nail 12 on threads 52.
FIGS. 2-3 are exemplary embodiments of uses for the intramedullary fixation device for use in ankle arthrodesis. FIG. 2 is a side view of the nail 12 in a non-compressed state in position within the tibia (T), talus (A) and calcaneus (C) bones. FIG. 3 is the nail 12 of FIG. 2 in a compressed state. FIG. 4B is the nail of FIG. 2 in a non-compressed state along with the compression disc 150 being placed against the heel bone. FIGS. 2 and 4B also show the direction of compression.
FIGS. 18-20 are exemplary alternate embodiments of uses for the intramedullary fixation device. FIG. 18 is a side view of the intramedullary fixation device of the present invention as applied to an fifth metatarsal fracture in an uncompressed configuration. The proximal portion 14 of nail 12 is secured to a first portion of a metatarsal bone and the distal portion 16 of nail 12 is secured to a second portion of the metatarsal bone. The direction of compression is also shown. A compression disc 150 would also be used and placed to provide a compressive force on the bones during compression of the nail 12 but prior to the distal portion 16 being affixed to the second portion of the metatarsal bone. The compression disc 150 may be placed internal or external to the body.
FIG. 19 is a side view of the intramedullary fixation device of the present invention as applied to a long bone fracture in an uncompressed configuration. The proximal portion 14 of nail 12 is secured to a first portion of a long bone and the distal portion 16 of nail 12 is secured to a second portion of the long bone. The direction of compression is also shown. The long bone may be any bone having a fracture which would benefit from the compressive forces of nail 12 being applied thereupon. Examples of a long bone include the tibia and femur. A compression disc 150 would also be used and placed to provide a compressive force on the bones during compression of the nail 12 but prior to the distal portion 16 being affixed to the second portion of the long bone. The compression disc 150 may be placed internal or external to the body.
FIG. 20 is a side view of the intramedullary fixation device of the present invention as applied to subtalar joint fusion in an uncompressed configuration. The proximal portion 14 of nail 12 is secured to the talus (A) and the distal portion 16 of nail 12 is secured to the calcaneus (C) bones. The direction of compression is also shown. A compression disc 150 would also be used and placed to provide a compressive force on the bones during compression of the nail 12 but prior to the distal portion 16 being affixed to the second portion of the calcaneus bone. The compression disc 150 may be placed internal or external to the body.
While the present invention has been described at some length and with some particularity with respect to the several described embodiments, it is not intended that it should be limited to any such particulars or embodiments or any particular embodiment, but it is to be construed with references to the appended claims so as to provide the broadest possible interpretation of such claims in view of the prior art and, therefore, to effectively encompass the intended scope of the invention.

## Claims

1. An intramedullary fixation device comprising:
(a) a distal section having a reduced diameter arm on its upper end and an internal bore having a first section and a second section, the second section having a smaller diameter than the first section;
(b) a proximal section having an internal bore in its rearward end, the bore having a threaded area and a non threaded area, the non threaded area being sized to slidingly receive the reduced diameter arm;
(c) a connecting member for adjustably securing the distal and proximal sections end to end along a longitudinal axis, the forward end of the connecting member being threadably received in the threaded area of the proximal section internal bore, and the rearward end being sized to be received in the first section of the internal bore in the distal section;
(d) means for securing the proximal section to a first bone; and
(e) means for securing the distal section to a least one different bone, wherein the connecting member can provide compression across a bone arthrodesis site by rotating within the proximal and distal sections.

2. The device of claim 1, wherein the connecting member further includes a socket adapted to receive a driving device to facilitate rotating the connecting member.

3. The device of claim 1, further comprising a clip secured to the connecting member for preventing the rearward end area of the connecting member from being received in the threaded area of the proximal section internal bore.

4. The device of claim 1, further comprising a plate adapted to be affixed to a lower end of the distal section to provide compression across a bone arthrodesis site.

5. The device of claim 4, further comprising a detachable outrigger assembly for positioning the plate and the intramedullary fixation device.

6. The device of claim 1, wherein the threaded area of the proximal section internal bore further includes at least one notch for aligning the proximal section with the second section of the distal section.

7. The device of claim 5, wherein the first section of the distal section further comprises at least one notch for aligning the first section of the distal section with the outrigger assembly.

8. The device of claim 7, wherein the outrigger assembly comprises a shaft comprising at least one tab for engaging the at least one notch of the first section of the distal section of the intramedullary fixation device.

9. The device of claim 8, wherein the shaft of the outrigger assembly further engages at least one tab on the plate.

10. The device of claim 5, wherein the outrigger assembly is operable to be rotated about the longitudinal axis.

11. The device of claim 1, wherein the means for securing the proximal section comprises at least one hole in the proximal section and at least one screw adapted to be received in said hole; and wherein the means for securing the distal section comprises at least one hole in the distal section and at least one screw adapted to be received in said hole.

12. The device of claim 11, further comprising a detachable outrigger assembly for positioning the plate and the intramedullary fixation device.

13. The device of claim 12, wherein the outrigger assembly further comprises a proximal drilling guide for aligning a drill with a hole in the proximal section and a distal drilling guide for aligning a drill with a hold in the distal section.

14. The device of claim 13, wherein the outrigger assembly is operable to be rotated about the longitudinal axis.

15. A method of utilizing an intramedullary fixation device to stabilize one or more bones comprising the steps of:
(a) providing an intramedullary fixation device comprising:
(i) a distal section having a reduced diameter arm on its upper end and an internal bore having a first section and a second section, the second section having a smaller diameter than the first section;
(ii) a proximal section, the proximal section having an internal bore in its rearward end, the bore having a threaded area and a non threaded area, the non threaded area being sized to slidingly receive the reduced diameter arm;
(iii) a connecting member for adjustably securing the distal and proximal sections end to end along a longitudinal axis, the forward end of the connecting member being threadably received in the threaded area of the proximal section internal bore, and the rearward end being sized to be received in the first section of the internal bore is the distal section;
(iv) means for securing the proximal section to a first bone; and
(v) means for securing the distal section to a least one different bone, wherein the connecting member is rotated to provide compression across a bone arthrodesis site to be stabilized and fused;

(b) preparing the ankle joint to receive the intramedullary fixation device;
(c) applying the intramedullary fixation device in the proper position with respect to the ankle joint;
(d) securing the proximal end of the intramedullary fixation device to a first bone or bone section;
(e) securing the distal end of the intramedullary fixation device to at least one second bone forming the ankle joint; and
(f) applying a compression force across the bones of the ankle joint.

16. The method of claim 15, wherein applying the compression force across the one or more bones is provided by the intramedullary fixation device.

17. The method of claim 16, wherein applying the compression force across the bones of the ankle joint is further provided by a plate abutting against the bottom surface of the heel.

18. The method of claim 17, wherein the intramedullary fixation device comprises
(a) a distal section having a reduced diameter arm on its upper end and an internal bore having a first section and a second section, the second section having a smaller diameter than the first section;
(b) a proximal section having an internal bore in its rearward end, the bore having a threaded area and a non threaded area, the non threaded area being sized to slidingly receive the reduced diameter arm;
(c) a connecting member for adjustably securing the distal and proximal sections end to end along a longitudinal axis, the forward end of the connecting member being threadably received in the threaded area of the proximal section internal bore, and the rearward end being sized to be received in the first section of the internal bore in the distal section,
(d) means for securing the proximal section to a first bone; and
(e) means for securing the distal section to a least one different bone, wherein the connecting member is rotated to provide compression across a bone arthrodesis site to be stabilized and fused.

19. The method of claim 15, wherein the one or more bones is an ankle joint comprising a tibia bone, a calcaneus bone, and a talus bone.

20. The method of claim 15, wherein the one or more bones is a foot joint comprising a calcaneus bone and a talus bone.

21. The method of claim 15, wherein the one or more bones is a foot bone.

22. The method of claim 15, wherein the one or more bones is a leg bone.